A Randomized, Double-Blind, Multicentric, Parallel Group Therapeutic Equivalence Study Comparing Efficacy, Safety and Immunogenicity of Subcutaneous DMB-3115 and Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis

This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of subcutaneously administered DMB-3115 in comparison with Stelara for treatment of moderate to severe chronic plaque psoriasis.

Start Date28 Apr 2021

Sponsor / Collaborator

Dong-A ST Co., Ltd.

[+1]

100 Clinical Results associated with Ustekinumab biosimilar (Accord BioPharma)

100 Translational Medicine associated with Ustekinumab biosimilar (Accord BioPharma)

100 Patents (Medical) associated with Ustekinumab biosimilar (Accord BioPharma)

Literatures (Medical) associated with Ustekinumab biosimilar (Accord BioPharma)

01 Feb 2026·JAAD international

A randomized, double-blind, phase 3 study to compare efficacy, safety, and immunogenicity between DMB-3115 and reference product ustekinumab in patients with moderate-to-severe chronic plaque psoriasis

Article

Author: Cetkovska, Petra ; Vekovska, Kamelia ; Draelos, Zoe Diana ; Weglowska, Jolanta ; Tichý, Martin ; Imko-Walczuk, Beata ; Rich, Phoebe

Background:

DMB-3115 is a biosimilar to Stelara (hereinafter referred to as ustekinumab).

Objectives:

To evaluate the clinical similarity of DMB-3115 with ustekinumab in patients with moderate-to-severe plaque psoriasis.

Methods:

In this phase 3, randomized, double-blind, parallel-arm study, adults with moderate-to-severe plaque psoriasis were randomized to receive DMB-3115 or ustekinumab (weeks 0-28), followed by re-randomization to continue treatment or switch to DMB-3115 (weeks 28-52). The primary efficacy endpoints were percent change in Psoriasis Area and Severity Index score from baseline to week 8 and week 12. The safety endpoint was the incidence of adverse events.

Results:

A total of 598 patients were randomized to receive DMB-3115 (n = 299) or ustekinumab (n = 299). The least squares mean percent changes in Psoriasis Area and Severity Index score from baseline to week 8 were 77.5% (DMB-3115) and 77.9% (ustekinumab), and from baseline to week 12 were 87.6% (DMB-3115) and 87.9% (ustekinumab). Rates of treatment-emergent adverse events were similar between treatments during period 1 (DMB-3115: 47.5%; ustekinumab: 49.8%) and period 2 (DMB-3115: 18.7%; ustekinumab: 21.2%; switched to DMB-3115: 18.3%).

Limitations:

Data were only through week 52.

Conclusions:

DMB-3115 showed a similar clinical efficacy and safety profile to ustekinumab in patients with moderate-to-severe plaque psoriasis.

01 Sep 2025·ADVANCES IN THERAPY

Pharmacokinetic Bioequivalence, Safety, and Immunogenicity of DMB-3115, an Ustekinumab Biosimilar, and EU- and US-Stelara in Healthy Adult Participants: A Randomized, Double-Blind, Single-Dose Study

Article

Author: Cho, Naoki ; Koernicke, Thomas ; Morita, Jun ; Fushimi, Hideki ; Fuhr, Rainard ; Mencarini, Thin Thin

INTRODUCTION:

The aim of this study was to investigate the pharmacokinetic bioequivalence between DMB-3115 and ustekinumab (EU-Stelara or US-Stelara) as well as the safety and immunogenicity of these drugs in healthy adult participants.

METHODS:

This was a randomized, double-blind, three-arm parallel-group study. Healthy participants aged 18-55 years were randomly assigned in a 1:1:1 ratio to receive a single subcutaneous injection (45 mg) of either DMB-3115, EU-Stelara, or US-Stelara. Participants were stratified into two body weight groups (< 80 vs. ≥ 80 kg). Participants were followed for 16 weeks. The primary pharmacokinetic (PK) endpoints were area under the concentration-time curve from time zero to infinity (AUC_inf), AUC from time zero to the time of the last quantifiable concentration (AUC_last), and maximum serum concentration (C_max). Immunogenicity was tested using antidrug antibody (ADA) assays.

RESULTS:

A total of 296 participants (n = 99 in the DMB-3115 group, n = 99 in the EU-Stelara group, and n = 98 in the US-Stelara group) received the study drug and were included in the safety analysis. Of these, one participant in the DMB-3115 group had no valid PK data and was excluded from the PK analysis. The 95% confidence intervals (CI) for the ratios of geometric least squares means (DMB-3115/EU-Stelara and DMB-3115/US-Stelara) of the primary PK endpoints (AUC_inf, AUC_last, and C_max) were within the prespecified bioequivalence range of 80-125%. Originally this study was designed for the comparison of EU and US Stelara with two formulations of DMB-3115. To avoid multiplicity, a 95% CI was chosen. After that, only one formulation was selected. However, overall design was not changed. Using a 95% CI provided a more stringent level for the bioequivalence evaluation and was acceptable for European Medical Agency and US Food and Drug Administration. The proportions of participants reporting any treatment-emergent adverse event (TEAE) were similar among the three groups. The most common TEAEs were headache, nasopharyngitis, back pain, diarrhea, and oropharyngeal pain. Most TEAEs were mild or moderate in severity, and no TEAEs led to study discontinuation. The incidences of participants with post-dose ADAs and neutralizing antibodies in DMB-3115 tended to be lower among the groups.

CONCLUSION:

DMB-3115 was bioequivalent to both reference ustekinumab in terms of pharmacokinetic profile and showed similar safety and immunogenicity profile after a single subcutaneous injection in parallel groups of healthy adult participants.

CLINICAL TRIAL REGISTRATION:

European Union Clinical Trials Register: number 2018-004033-33; date of registration 17 October 2018.

01 Nov 2011·mAbsQ2 · MEDICINE

Discovery and mechanism of ustekinumab

Q2 · MEDICINE

Review

Author: Jill M. Giles-Komar ; Jacqueline M. Benson ; David Peritt ; Mary Ann Mascelli ; George A. Heavner ; David J. Shealy ; Bernard J. Scallon

Monoclonal antibody (mAb) therapy was first established upon the approval of a mouse antibody for treatment of human acute organ rejection. However, the high incidence of immune response against the mouse mAb restricted therapeutic utility. Development of chimeric, "humanized" and human mAbs broadened therapeutic application to immune-mediated diseases requiring long-term treatment. Indeed, mAb therapeutics targeting soluble cytokines are highly effective in numerous immune-mediated disorders. A recent example is ustekinumab, a first-in-class therapeutic human immunoglobulin G1 kappa mAb that binds to the interleukins (IL)-12 and IL-23, cytokines that modulate lymphocyte function, including T-helper (Th) 1 and Th17 cell subsets. Ustekinumab was generated via recombinant human IL-12 immunization of human immunoglobulin (hu-Ig) transgenic mice. Ustekinumab binds to the p40 subunit common to IL-12 and IL-23 and prevents their interaction with the IL-12 receptor β1 subunit of the IL-12 and IL-23 receptor complexes. Ustekinumab is approved for treatment of moderate-to-severe plaque psoriasis and has demonstrated efficacy in Crohn disease and psoriatic arthritis. The clinical characterization of ustekinumab continues to clarify our understanding of human immune pathologies and may offer a novel therapeutic option for certain immune-mediated diseases.

News (Medical) associated with Ustekinumab biosimilar (Accord BioPharma)

18 May 2026

·www.biospace.com

FDA Approves IMMGOLIS™ (golimumab-sldi) and IMMGOLIS INTRI™ (golimumab-sldi), First Biosimilars to Simponi® (golimumab) and Simponi Aria® (golimumab); Accord BioPharma to Lead U.S. Commercialization

FDA approval of IMMGOLIS and IMMGOLIS INTRI breaks new ground in patient access, marking the first biosimilar option to golimumab biologic therapy in the U.S. IMMGOLIS is approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA), in combination with methotrexate, and moderately to severely active ulcerative colitis (UC), while IMMGOLIS INTRI is approved for the treatment of adults with moderately to severely active RA in combination with methotrexate Accord BioPharma expands growing biosimilar portfolio as exclusive U.S. commercialization partner for IMMGOLIS and IMMGOLIS INTRI RALEIGH, N.C. , May 18, 2026 /PRNewswire/ -- Accord BioPharma , Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas Pharmaceuticals"), focused on the development of oncology, immunology and central nervous system (CNS) therapies, announced today that the U.S. Food and Drug Administration (FDA) has approved IMMGOLIS™ (golimumab-sldi), a biosimilar to Simponi® (golimumab), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate, and adult patients with moderately to severely active ulcerative colitis (UC). The FDA also approved IMMGOLIS INTRI™ (golimumab-sldi), a biosimilar to Simponi Aria® (golimumab), for the treatment of adults with moderately to severely active RA in combination with methotrexate. Simponi, Simponi Aria, IMMGOLIS, and IMMGOLIS INTRI each carry a Boxed Warning for Serious Infections and Malignancy; please see the Boxed Warnings for IMMGOLIS and IMMGOLIS INTRI below. 1,2 IMMGOLIS and IMMGOLIS INTRI are the first FDA-approved golimumab biosimilars, and will be commercialized in the United States exclusively by Accord BioPharma. IMMGOLIS and IMMGOLIS INTRI were designated interchangeable by the FDA for rheumatoid arthritis and ulcerative colitis. For the first time, patients with rheumatoid arthritis and ulcerative colitis will have an FDA-approved biosimilar option for both Simponi and Simponi Aria, a pivotal step toward broader access to biologic therapy. As the exclusive U.S. commercialization partner for IMMGOLIS and IMMGOLIS INTRI, Accord BioPharma plans to make these products available to patients and providers in Q4 2026. "As the first golimumab biosimilars approved in the U.S., IMMGOLIS and IMMGOLIS INTRI represent a meaningful new option for people in the U.S. who are living with the chronic, debilitating autoimmune conditions associated with moderately to severely active rheumatoid arthritis or ulcerative colitis and need more affordable medication," said Chrys Kokino, President of Accord North America. "This approval answers a clear demand in the U.S. market and helps advance our ambitious goal to bring 20 biosimilars to market by the year 2030." "Biosimilars are one of the most powerful tools we have to improve affordability and access across the U.S. healthcare system," said Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals." With Accord BioPharma's deep expertise, dedicated team, and bold vision, the team is well positioned to bring this first-of-its-kind product to U.S. patients and providers later this year." IMMGOLIS and IMMGOLIS INTRI were developed by Bio-Thera Solutions, which will maintain responsibility for manufacturing and product supply. IMMGOLIS is not indicated for and should not be used or administered for the treatment of adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate; adult patients with active ankylosing spondylitis (AS); or pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis (UC). IMMGOLIS INTRI is not indicated for and should not be used or administered for the treatment of Active Psoriatic Arthritis (PsA) in patients 2 years of age and older; adult patients with active Ankylosing Spondylitis (AS); or Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older. IMPORTANT SAFETY INFORMATION IMMGOLIS (golimumab-sldi) injection, for subcutaneous use IMMGOLIS (golimumab-sldi) is a biosimilar* to SIMPONI ® (golimumab) IMMGOLIS INTRI (golimumab-sldi) injection, for intravenous use IMMGOLIS INTRI (golimumab-sldi) is a biosimilar* to SIMPONI ARIA ® (golimumab) BOXED WARNING AND IMPORTANT SAFETY INFORMATION WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving golimumab products. Discontinue IMMGOLIS/IMMGOLIS INTRI if a patient develops a serious infection or sepsis. Perform test for latent TB; if positive, start treatment for TB prior to starting IMMGOLIS/IMMGOLIS INTRI. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children. and adolescent patients treated with TNF blockers, of which IMMGOLIS/IMMGOLIS INTRI is a member. Serious Infections: Patients treated with golimumab products are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Discontinue IMMGOLIS/IMMGOLIS INTRI if a patient develops a serious infection. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, or parasitic organisms including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, and tuberculosis have been reported with TNF-blockers, of which IMMGOLIS/IMMGOLIS INTRI is a member. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. The concomitant use of a TNF-blocker and abatacept or anakinra was associated with a higher risk of serious infections; therefore, the concomitant use of IMMGOLIS/IMMGOLIS INTRI and these biologic products is not recommended. Treatment with IMMGOLIS/IMMGOLIS INTRI should not be initiated in patients with an active infection, including clinically important localized infections. Patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants such as corticosteroids or methotrexate may be at greater risk of infection. Monitoring Closely monitor patients for the development of signs and symptoms of infection during and after treatment with IMMGOLIS/IMMGOLIS INTRI. Discontinue IMMGOLIS/IMMGOLIS INTRI if a patient develops a serious infection, an opportunistic infection, or sepsis. For a patient who develops a new infection during treatment with IMMGOLIS/IMMGOLIS INTRI, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, initiate appropriate antimicrobial therapy, and closely monitor them. Tuberculosis Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving TNF-blockers, including patients who have previously received treatment for latent or active tuberculosis. Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating IMMGOLIS/IMMGOLIS INTRI and periodically during therapy. Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient. Invasive Fungal Infections If patients develop a serious systemic illness and they reside or travel in regions where mycoses are endemic, consider invasive fungal infection in the differential diagnosis. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections and consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections. Hepatitis B Reactivation The use of TNF blockers, of which IMMGOLIS/IMMGOLIS INTRI is a member, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic HBV carriers. In some instances, HBV reactivation occurring in conjunction with TNF-blocker therapy has been fatal. The majority of these reports have occurred in patients who received concomitant immunosuppressants. All patients should be tested for HBV before initiating TNF-blocker therapy. For patients who test positive for hepatitis B surface antigen, consult a physician with expertise in the treatment of hepatitis B before initiating TNF-blocker therapy. Exercise caution when prescribing IMMGOLIS/IMMGOLIS INTRI for patients identified as carriers of HBV and closely monitor for active HBV infection during and following termination of therapy. Discontinue IMMGOLIS/IMMGOLIS INTRI in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of IMMGOLIS/IMMGOLIS INTRI and monitor patients closely. Malignancies: Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy ≤ 18 years of age), of which IMMGOLIS/IMMGOLIS INTRI is a member. Most of the patients were receiving concomitant immunosuppressants. The risks and benefits of IMMGOLIS/IMMGOLIS INTRI should be considered prior to initiating therapy in patients with a known malignancy other than a successfully treated nonmelanoma skin cancer (NMSC) or when considering continuing a TNF-blocker in patients who develop a malignancy. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocking agents, including golimumab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. Congestive Heart Failure (CHF): Cases of worsening CHF and new onset CHF have been reported with TNF blockers, including golimumab products. Some cases had a fatal outcome. Patients with CHF should be closely monitored during therapy. Discontinue IMMGOLIS/IMMGOLIS INTRI if new or worsening symptoms of CHF appear. Demyelinating Disorders: Use of TNF blockers, of which IMMGOLIS/IMMGOLIS INTRI is a member, has been associated with rare cases of new onset or exacerbation of central nervous system demyelinating disorders, including multiple sclerosis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Prescribers should exercise caution in considering the use of IMMGOLIS/IMMGOLIS INTRI in patients with central or peripheral nervous system demyelinating disorders. Consider discontinuation of IMMGOLIS/IMMGOLIS INTRI if these disorders develop. Autoimmunity: Treatment with TNF blockers, including IMMGOLIS/IMMGOLIS INTRI, may result in the formation of antinuclear antibodies and rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with IMMGOLIS/IMMGOLIS INTRI, treatment should be discontinued. Use with Other Drugs: The concomitant use of a TNF blocker and abatacept or anakinra was associated with a higher risk of serious infections; therefore, the use of IMMGOLIS/IMMGOLIS INTRI in combination with these products is not recommended. Care should be taken when switching between biological disease modifying antirheumatic drugs since overlapping biological activity may further increase the risk of infection. Upon initiation or discontinuation of IMMGOLIS/IMMGOLIS INTRI in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed. Hematologic Cytopenias: There have been reports of pancytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anemia, and thrombocytopenia in patients receiving golimumab products. Exercise caution when using TNF blockers, including IMMGOLIS/IMMGOLIS INTRI, in patients who have or have had significant cytopenias. Vaccinations/Therapeutic Infectious Agents: Patients treated with IMMGOLIS/IMMGOLIS INTRI may receive vaccinations, except for live vaccines. If possible, it is recommended that prior to initiating therapy with IMMGOLIS/IMMGOLIS INTRI, patients be brought up to date with all immunizations in agreement with current immunization guidelines. It is recommended that therapeutic infectious agents not be given concurrently with IMMGOLIS/IMMGOLIS INTRI due to the possibility of clinical infections, including disseminated infections. Hypersensitivity Reactions: Serious systemic hypersensitivity reactions (including anaphylaxis) have been reported following golimumab product administration. Some reactions occurred after the first administration of golimumab products. If an anaphylactic or other serious allergic reaction occurs, discontinue IMMGOLIS/IMMGOLIS INTRI and institute appropriate therapy. Most Common Adverse Reactions: Most common adverse reactions with IMMGOLIS in adults (incidence > 5%) are upper respiratory tract infection, nasopharyngitis, and injection site reactions. Most common adverse reactions with IMMGOLIS INTRI (incidence ≥ 3%) are: upper respiratory tract infection, alanine aminotransferase increased, viral infection, aspartate aminotransferase increased, neutrophil count decreased, bronchitis, hypertension, and rash. INDICATIONS IMMGOLIS is a tumor necrosis factor (TNF) blocker indicated for the treatment of: adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate adult patients with moderately to severely active ulcerative colitis (UC) IMMGOLIS INTRI is a tumor necrosis factor (TNF) blocker indicated for the treatment of: adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or . IMMGOLIS (golimumab-sldi) injection is supplied in a 50 mg/0.5 mL and 100 mg/mL single-dose prefilled syringe. IMMGOLIS INTRI (golimumab-sldi) injection is supplied in a 50 mg/4 mL (12.5 mg/mL) solution in a single-dose vial. Click here for full Prescribing Information for IMMGOLIS. Click here for full Prescribing Information for IMMGOLIS INTRI. SIMPONI and SIMPONI ARIA ® (golimumab)are registered trademarks of Johnson & Johnson and its affiliates. About Accord BioPharma Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and central nervous system (CNS) therapies. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. The company is advancing an ambitious pipeline with the goal of bringing 20 biosimilars to the U.S. market by 2030. The company's current commercial portfolio includes the full UDENYCA ® (pegfilgrastim-cbqv) franchise, including the UDENYCA prefilled syringe, autoinjector, and on-body injector, IMULDOSA ® (ustekinumab-srlf), a biosimilar to Stelara ® (ustekinumab), HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin ® (trastuzumab), and CAMCEVI ® (leuprolide) 42 mg injectable emulsion. Please refer to the Important Safety Information and full Prescribing Information for these products, and to the Boxed Warning for HERCESSI. Accord BioPharma has received FDA approval on five additional products: CAMCEVI ® (leuprolide) ETM (every three months), OSVYRTI ® (denosumab-desu) – a biosimilar to PROLIA ® (denosumab), JUBEREQ ® (denosumab-desu) – a biosimilar to XGEVA ® (denosumab), FILKRI™ (filgrastim-laha) – a biosimilar to NEUPOGEN® (filgrastim), and ENNUMO™ (pegfilgrastim-pccg) – a biosimilar to NEULASTA® (pegfilgrastim). The company plans to announce the commercial launch of these products later this year. Please refer to the Important Safety Information and full Prescribing Information for these products, and to the Boxed Warning for OSVYRTI. For more information, visit AccordBioPharma.com . About Bio-Thera Solutions Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. For more information, please visit References: IMMGOLIS (golimumab-sldi) Full Prescribing Information. Accord BioPharma. IMMGOLIS INTRI (golimumab-sldi) Full Prescribing Information. Accord BioPharma. All trademarks, logos and brand names are the property of their respective owners. Contact: abipr@accordhealthcare.com View original content to download multimedia: SOURCE Accord BioPharma

Drug ApprovalClinical ResultBiosimilar

17 Feb 2026

·www.biospace.com

/C O R R E C T I O N -- Accord BioPharma/

In the news release, FDA Approves FILKRI™ (filgrastim-laha), Accord BioPharma's Biosimilar to NEUPOGEN® (filgrastim), issued 17-Feb-2026 by Accord BioPharma over PR Newswire, we are advised by the company that changes have been made. The complete, corrected release follows, with additional details at the end: FDA Approves FILKRI™ (filgrastim-laha), Accord BioPharma’s Biosimilar to NEUPOGEN® (filgrastim) FILKRI completes Accord BioPharma's comprehensive granulocyte colony-stimulating factor (G-CSF) portfolio alongside UDENYCA ® (pegfilgrastim-cbqv ) RALEIGH, N.C. , Feb. 17, 2026 /PRNewswire/ -- Accord BioPharma , the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced that the U.S. Food and Drug Administration (FDA) has approved FILKRI™ (filgrastim-laha), a biosimilar to NEUPOGEN ® (filgrastim), for patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients with cancer undergoing bone marrow transplantation; patients with severe chronic neutropenia; and patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome). 1 The approval of FILKRI marks the sixth product in Accord BioPharma's growing portfolio of FDA-approved biosimilars, following the company's acquisition last year of UDENYCA ® (pegfilgrastim-cbqv), a biosimilar to Neulasta ® (pegfilgrastim), 2 as well as the seventh approved product in the overall portfolio. With the addition of FILKRI, Accord BioPharma now offers physicians in the U.S. a comprehensive granulocyte colony-stimulating factor (G-CSF) portfolio with both long-acting (UDENYCA) and short-acting (FILKRI) biosimilar options to meet the needs of patients, providers, and practices. 1,2 Accord has applied for and expects to receive a permanent Q-code from the U.S. Centers for Medicare & Medicaid Services (CMS), which will standardize and facilitate the billing and reimbursement process across hospital outpatient, ambulatory surgery center, and physician office settings of care. Tackling Vital Healthcare Needs Neutropenia is a common and potentially serious complication of cancer treatment and occurs when white blood cells called neutrophils—which serve as a major line of defense against bacterial and fungal infections—fall below normal levels. This reduction increases a person's risk of developing an infection. Granulocyte colony-stimulating factor, or G-CSF, is a growth factor that stimulates the production and release of neutrophils in the body. By accelerating neutrophil recovery, G-CSF can help reduce the duration of neutropenia. 3,4 FILKRI belongs to the G-CSF class and is a growth factor manufactured by recombinant DNA technology. FILKRI works by regulating the production of neutrophils within the bone marrow. 1 "Cancer patients often face significant challenges with treatment-related neutropenia, which can lead to serious infections, treatment delays, and dose reductions that may compromise therapeutic outcomes," said Chrys Kokino, President, Accord North America. "With FILKRI alongside UDENYCA, the provider-preferred option over Neulasta and all other biosimilars,* we now offer healthcare providers a complete G-CSF portfolio with short- and long-acting biosimilar options. This positions Accord BioPharma as a committed partner in oncology supportive care, expanding access to high-quality biologics." Demonstrated Biosimilarity and Safety Profile FILKRI was approved based on two randomized studies in healthy adults, with pharmacokinetics (PK)/pharmacodynamics (PD) assessed in one study and safety and immunogenicity evaluated in both, compared with reference product NEUPOGEN. These studies demonstrated the biosimilarity in PD and PK parameters between FILKRI and NEUPOGEN and showed overall safety and immunogenicity similar to NEUPOGEN. 5 FILKRI is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors, such as filgrastim products or pegfilgrastim products. 1 Expanding Access: Accord BioPharma's Biosimilar Vision Accord BioPharma believes deeply in the power of biosimilars to reshape the future of treatment. With the support of Intas, an established global leader with nearly five decades of experience, Accord BioPharma is transforming the conventional treatment landscape across several priority therapeutic areas by introducing biosimilars to the U.S. market. As part of this commitment, Accord BioPharma is rapidly expanding its U.S. portfolio with a strategic goal to launch 20 biosimilar products by 2030, solidifying its position as a reliable partner delivering more affordable, high-quality biologic alternatives. In addition to developing and marketing their own biosimilar products, the company is strategically collaborating with select partners around the world to bring more biosimilars to the U.S. market as swiftly as possible. "This approval of FILKRI demonstrates our steadfast dedication to expanding access to cost-effective biologic treatments in the critically important field of oncology," said Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals. "We're proud to have one of the largest biosimilar pipelines within the industry. With Accord BioPharma, we're positioning ourselves as a dependable partner in the United States—one that's deeply committed to understanding stakeholder priorities and revolutionizing patient access." Current Portfolio of Brands The company's current commercial portfolio includes the full UDENYCA franchise, including the UDENYCA prefilled syringe, autoinjector, and on-body injector, IMULDOSA ® (ustekinumab-srlf), a biosimilar to Stelara ® (ustekinumab), HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin ® (trastuzumab), and CAMCEVI ® (leuprolide) 42 mg injectable emulsion. 6,7 Please refer to the Important Safety Information and full Prescribing Information for these products, and to the Boxed Warning for HERCESSI. Accord BioPharma has received FDA approval on three additional products: CAMCEVI ® (leuprolide) ETM (every three months), OSVYRTI ® (denosumab-desu), a biosimilar to PROLIA ® (denosumab), and JUBEREQ ® (denosumab-desu), a biosimilar to XGEVA ® (denosumab). 8,9 The company plans to announce the commercial launch of these products later this year. Please refer to the Important Safety Information and full Prescribing Information for these products, and to the Boxed Warning for OSVYRTI. Contact: abipr@accordhealthcare.com IMPORTANT SAFETY INFORMATION FILKRI is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors (G-CSFs) such as filgrastim or pegfilgrastim products. Splenic Rupture: Splenic rupture, including fatal cases, has been reported following the administration of filgrastim products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. Acute Respiratory Distress Syndrome (ARDS): ARDS has been reported in patients receiving filgrastim products . Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS . Discontinue FILKRI in patients with ARDS. Serious Allergic Reactions: Serious allergic reactions, including anaphylaxis, have been reported in patients receiving filgrastim products . The majority of reported events occurred upon initial exposure . Provide symptomatic treatment for allergic reactions. Allergic reactions, including anaphylaxis, in patients receiving filgrastim products can recur within days after the discontinuation of initial anti-allergic treatment . Permanently discontinue FILKRI in patients with serious allergic reactions. Sickle Cell Disorders: Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim products . Discontinue FILKRI if sickle cell crisis occurs. Glomerulonephritis: Has occurred in patients receiving filgrastim products . Diagnoses were based on azotemia, hematuria, proteinuria, and renal biopsy . Generally, events resolved after dose reduction or discontinuation of filgrastim products . If causality is likely, consider dose-reduction or interruption of FILKRI. Alveolar Hemorrhage and Hemoptysis: Alveolar hemorrhage, manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization, have been reported in FILKRI-treated healthy donors undergoing peripheral blood progenitor cell (PBPC) collection mobilization . Hemoptysis resolved with discontinuation of filgrastim products. The use of FILKRI for PBPC mobilization in healthy donors is not an approved indication. Capillary Leak Syndrome (CLS): CLS has been reported after G-CSF administration, including filgrastim products and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity, and may be life-threatening if treatment is delayed . Patients with symptoms should be closely monitored and receive appropriate treatment. Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Patients with Severe Chronic Neutropenia (SCN ): Confirm the diagnosis of SCN before initiating FILKRI therapy. MDS and AML have been reported to occur in the natural history of congenital neutropenia without cytokine therapy. Cytogenetic abnormalities, transformation to MDS, and AML have also been observed in patients treated with filgrastim products for SCN. Abnormal cytogenetics and MDS have been associated with the eventual development of myeloid leukemia. The effect of filgrastim products on the development of abnormal cytogenetics and the effect of continued filgrastim administration in patients with abnormal cytogenetics or MDS are unknown. Monitor patients for signs and symptoms of MDS/AML in these settings. If a patient with SCN develops abnormal cytogenetics or myelodysplasia‚ the risks and benefits of continuing FILKRI should be carefully considered. Patients with Breast and Lung Cancer : MDS and AML have been associated with the use of filgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings. Thrombocytopenia: Thrombocytopenia has been reported in patients receiving filgrastim products. Monitor platelet counts. Leukocytosis: Patients with Cancer Receiving Myelosuppressive Chemotherapy : White blood cell counts ≥ 100,000/mm 2 were observed in about 2% of patients who received filgrastim products at dosages above 5 mcg/kg/day. Discontinue FILKRI if the absolute neutrophil count (ANC) surpasses 10,000/mm 2 after the chemotherapy-induced ANC nadir has occurred. Monitor CBCs at least twice weekly during therapy with FILKRI. Discontinuation of filgrastim therapy usually resulted in a 50% decrease in circulating neutrophils within 1 to 2 days‚ with a return to pretreatment levels in 1 to 7 days. Cutaneous Vasculitis: Moderate or severe cases of cutaneous vasculitis has been reported in patients treated with filgrastim products . Most reports involved patients with SCN receiving long-term filgrastim therapy . Hold FILKRI therapy in patients with cutaneous vasculitis . FILKRI dose may be reduced when the symptoms resolve and the ANC has decreased. Potential Effect on Malignant Cells: FILKRI is a growth factor that primarily stimulates neutrophils. The granulocyte colony-stimulating factor (G-CSF) receptor through which FILKRI acts has also been found on tumor cell lines. The possibility that FILKRI acts as a growth factor for any tumor type cannot be excluded. The safety of filgrastim products in chronic myeloid leukemia (CML) and myelodysplasia has not been established. Simultaneous Use with Chemotherapy and Radiation Not Recommended: The safety and efficacy of FILKRI given simultaneously with cytotoxic chemotherapy and radiation have not been established . Do not use FILKRI 24 hours before or after administration of cytotoxic chemotherapy . The safety and efficacy of FILKRI have not been evaluated in patients receiving concurrent radiation therapy . Avoid the simultaneous use of FILKRI with chemotherapy and radiation therapy. Nuclear Imaging: Increased hematopoietic activity of the bone marrow has been associated with transient positive bone-imaging changes on nuclear imaging. Aortitis: Aortitis has been reported in patients receiving filgrastim products . It may occur as early as the first week after start of therapy . Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count) . Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue FILKRI if aortitis is suspected. The most common adverse reactions in patients: with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (≥ 5% difference in incidence compared to placebo) are pyrexia, pain, rash, cough, and dyspnea with AML (≥ 2% difference in incidence) are pain, epistaxis and rash with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT (≥ 5% difference in incidence) is rash with severe chronic neutropenia (SCN) (≥ 5% difference in incidence) are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia INDICATIONS FILKRI is a leukocyte growth factor indicated to: Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or . FILKRI is supplied as single-dose prefilled syringes for subcutaneous or intravenous use in 300 mcg/0.5 mL and 480 mcg/0.8 mL strengths. For more information, please see the full Prescribing Information . About Accord BioPharma Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. Accord BioPharma believes in the ability of biosimilars to increase access and options for patients and deliver savings to the U.S. healthcare system, and is striving to offer one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com . *Based on cumulative average of prescriptions written from September 2025 - January 2026, according to IQVIA drug distribution data. References: FILKRI ® (filgrastim-laha) injection. Prescribing Information. Accord BioPharma. UDENYCA ® (pegfilgrastim-cbqv). Prescribing Information. Accord BioPharma. Simpson, P. Clinical Implications and Future Research of Neutrophils in Health and Disease. Immunome Research 2024;20(3): 1-2. Link, H. Current state and future opportunities in granulocyte colony‑stimulating factor (G‑CSF). Supportive Care in Cancer 2022;30:7067–7077. Accord BioPharma. Data on file. IMULDOSA ® (ustekinumab-srlf). Prescribing Information. Accord BioPharma. HERCESSI™ (trastuzumab-strf). Prescribing Information. Accord BioPharma. OSVYRTI ® (denosumab-desu). Prescribing Information. Accord BioPharma. JUBEREQ ® (denosumab-desu). Prescribing Information. Accord BioPharma. All trademarks, logos, and brand names are the property of their respective owners. Correction:  An earlier version of this release had the incorrect link to the full Prescribing Information. View original content to download multimedia: SOURCE Accord BioPharma

Drug ApprovalAcquisitionClinical ResultRadiation Therapy

05 Jan 2026

·www.biospace.com

Accord BioPharma’s HERCESSI™ (trastuzumab-strf) Gains Preferred Status on Express Scripts National Commercial Formularies

HERCESSI ™ becomes one of two trastuzumab biosimilars on preferred formulary placement, expanding patient access to more affordable HER2-targeted oncology therapies RALEIGH, N.C. , Jan. 5, 2026 /PRNewswire/ -- Accord BioPharma Inc., the specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced that Express Scripts, one of the nation's largest pharmacy benefit managers, has added HERCESSI™ (trastuzumab-strf) to preferred status on its largest commercial formularies, including National Preferred Formulary, effective January 1, 2026. HERCESSI is FDA-approved for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma and is a biosimilar with no clinically meaningful differences to its reference product, HERCEPTIN® (trastuzumab). 1 Please see below for full Indications and Important Safety Information. HERCESSI carries a Boxed Warning for cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity. The preferred placement on Express Scripts' formularies expands access to more affordable HER2-targeted therapy for cancer patients, and underscores Accord BioPharma's commitment to delivering high-quality, accessible oncology treatments. "Gaining preferred formulary status for HERCESSI reinforces the value biosimilars bring to the healthcare system," said Chrys Kokino, President and CEO of Accord U.S. "Express Scripts' decision to prioritize more affordable HER2-targeted treatment options helps ensure that cost doesn't prevent patients from receiving the cancer care they need." "This marks our second significant formulary agreement with Express Scripts within the last four months, following the addition of IMULDOSA (ustekinumab-srlf) in September," said Paul Purdy, VP, Head of Market Access at Accord BioPharma. "We're building meaningful partnerships with leading payers to create more accessible pathways to biologic treatments for patients facing cancer and other serious diseases, and we're actively pursuing similar opportunities with additional pharmacy benefit managers across the country." Eligible patients may access copay assistance for HERCESSI. For more details about the copay program and patient support services, please visit hercessi.com . Contact: abipr@accordhealthcare.com IMPORTANT SAFETY INFORMATION FOR HERCESSI™ (trastuzumab-strf) for injection, for intravenous use HERCESSI (trastuzumab-strf) is biosimilar to HERCEPTIN (trastuzumab). BOXED WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning Cardiomyopathy: T rastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue HERCESSI for cardiomyopathy. Infusion Reactions, Pulmonary Toxicity: Discontinue HERCESSI for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Embryo-Fetal Toxicity: Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception. ADDITIONAL IMPORTANT SAFETY INFORMATION Cardiomyopathy Trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. Trastuzumab products can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death Trastuzumab products can also cause asymptomatic decline in left ventricular ejection fraction (LVEF) Discontinue HERCESSI treatment in patients receiving adjuvant therapy and withhold HERCESSI in patients with metastatic disease for clinically significant decrease in left ventricular function Cardiac Monitoring Evaluate cardiac function prior to and during treatment. For adjuvant therapy, also evaluate cardiac function after completion of HERCESSI Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan Monitor frequently for decreased LVEF during and after HERCESSI treatment Monitor more frequently if HERCESSI is withheld for significant left ventricular cardiac dysfunction Infusion Reactions With trastuzumab products, serious and fatal infusion reactions have been reported Symptoms usually occur during or within 24 hours of trastuzumab product administration Interrupt HERCESSI infusion for dyspnea or clinically significant hypotension Monitor patients until symptoms completely resolve Discontinue HERCESSI for severe infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Strongly consider permanent discontinuation in all patients with severe infusion reactions Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion include nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia Embryo-Fetal Toxicity Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception Verify the pregnancy status of females of reproductive potential prior to the initiation of HERCESSI Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of HERCESSI. Advise female patients to contact their healthcare provider with a known or suspected pregnancy Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for HERCESSI treatment and any potential adverse effects on the breastfed child from HERCESSI or from the underlying maternal condition Pulmonary Toxicity Trastuzumab products can result in serious and fatal pulmonary toxicity , which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity Exacerbation of Chemotherapy-Induced Neutropenia In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not Most Common Adverse Reactions The most common adverse reactions associated with trastuzumab products in breast cancer are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia The most common adverse reactions associated with trastuzumab products in metastatic gastric cancer were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or . INDICATIONS Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. Adjuvant Breast Cancer HERCESSI TM (trastuzumab-strf) is indicated in adults for adjuvant treatment of HER2-overexpressing node positive or node negative (ER/PR-negative or with one high-risk feature) breast cancer: as part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel as part of a treatment regimen with docetaxel and carboplatin as a single agent following multi-modality anthracycline-based therapy Metastatic Breast Cancer HERCESSI is indicated in adults: in combination with paclitaxel for the first-line treatment of HER2-overexpressing metastatic breast cancer as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease Metastatic Gastric Cancer HERCESSI is indicated in adults, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease. HERCESSI TM (trastuzumab-strf) for injection is available as a single-dose vial for the 150 mg/vial strength and as a multiple-dose vial for the 420 mg/vial strength. Click here for full Prescribing Information, including Boxed Warnings . About Accord BioPharma Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., seeks to provide more affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. Accord BioPharma believes in the ability of biosimilars to increase access and options for patients and deliver savings to the U.S. healthcare system, and is striving to offer one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com . References: HERCESSI (trastuzumab-strf). Prescribing Information. Accord BioPharma. All trademarks, logos and brand names are the property of their respective owners. View original content to download multimedia: SOURCE Accord BioPharma

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100 Deals associated with Ustekinumab biosimilar (Accord BioPharma)

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KEGG	Wiki	ATC	Drug Bank
-	-	L04AC05	DB05679

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10 top approved records.

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Indication	Country/Location	Organization	Date
Crohn's disease, active moderate	European Union	Accord Healthcare SL	12 Dec 2024
Crohn's disease, active moderate	Iceland	Accord Healthcare SL	12 Dec 2024
Crohn's disease, active moderate	Liechtenstein	Accord Healthcare SL	12 Dec 2024
Crohn's disease, active moderate	Norway	Accord Healthcare SL	12 Dec 2024
Crohn's disease, active severe	European Union	Accord Healthcare SL	12 Dec 2024
Crohn's disease, active severe	Iceland	Accord Healthcare SL	12 Dec 2024
Crohn's disease, active severe	Liechtenstein	Accord Healthcare SL	12 Dec 2024
Crohn's disease, active severe	Norway	Accord Healthcare SL	12 Dec 2024
Ulcerative colitis, active moderate	European Union	Accord Healthcare SL	12 Dec 2024
Ulcerative colitis, active moderate	Iceland	Accord Healthcare SL	12 Dec 2024
Ulcerative colitis, active moderate	Liechtenstein	Accord Healthcare SL	12 Dec 2024
Ulcerative colitis, active moderate	Norway	Accord Healthcare SL	12 Dec 2024
Ulcerative colitis, active severe	European Union	Accord Healthcare SL	12 Dec 2024
Ulcerative colitis, active severe	Iceland	Accord Healthcare SL	12 Dec 2024
Ulcerative colitis, active severe	Liechtenstein	Accord Healthcare SL	12 Dec 2024
Ulcerative colitis, active severe	Norway	Accord Healthcare SL	12 Dec 2024
Arthritis, Psoriatic	United States	Accord BioPharma, Inc.	10 Oct 2024
Colitis, Ulcerative	United States	Accord BioPharma, Inc.	10 Oct 2024
Crohn Disease	United States	Accord BioPharma, Inc.	10 Oct 2024
Plaque psoriasis	United States	Accord BioPharma, Inc.	10 Oct 2024

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10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Psoriasis	Phase 1	Japan	Meiji Seika Pharma Co., Ltd.	01 Sep 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04785326 (Opportuniti, CTgov)	Phase 3	Plaque psoriasis	598	DMB-3115 (DMB-3115)	iyamwhslbg(khyivnpisj) = ngmvroygju sodfwosogb (ksnleljlwh, 2.595) View more	-	18 Jan 2024
				DMB-3115+Stelara (Stelara)	iyamwhslbg(khyivnpisj) = pyxwbjrjsj sodfwosogb (ksnleljlwh, 2.587) View more
Biospace Manual	Phase 1	Plaque psoriasis	296	DMB-3115	vettkaoqny(wpgvdowngt) = corresponded with the known safety profile of ustekinumab vzoklngtta (kazbliacbg )	Positive	21 May 2021
				Stelara

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