the goal of this study is to compare the efficacy of ustekinumab with infliximab for the treatment of ulcerative colitis aim of the study :
1. Compare effectiveness of ustekinumab versus infliximab therapy in remission achievement in UC patients.
2. Compare safety of ustekinumab therapy versus infliximab therapy in UC
3. To asses quality of life of ustekinumab therapy versus infliximab therapy in UC patients.

Start Date15 May 2025

Sponsor / Collaborator

Helwan University

NCT06788340

/ Not yet recruitingPhase 4IIT

MOdel-Informed Precision Dosing (MIPD) of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease - An Independent Randomized Controlled Trial

The goal of this clinical trial is to investigate if dosage of Ustekinumab (UST) and Vedolizumab (VDZ) based on Model-Informed Precision Dosing (MIPD) is equally as efficient in keeping adults with Inflammatory Bowel Disease (IBD) in remission as management based on what the treating physician deems best. The main question is:
Is using pharmacokinetic-pharmacodynamic (PK-PD) models to predict the appropriate dose and dosing interval for VDZ and UST at least as effective as current practices in maintaining IBD remission.
As above mentioned the comparison-group is adults with IBD, treated with UST or VDZ, managed as the physician deems best.
Participants will:
Have blood and stool tests done, as well as answer a questionnaire 4th weekly Have their dosage frequency decided on either by the PK-model or as the physician deems best visit the clinic once every 24 weeks for checkups. Have an endoscopy done at completion of the study (if the disease is primarily located in the small intestine, MRI or capsule endoscopy will be used instead)

Start Date01 Mar 2025

Sponsor / Collaborator

Odense University Hospital

100 Clinical Results associated with Ustekinumab

100 Translational Medicine associated with Ustekinumab

100 Patents (Medical) associated with Ustekinumab

3,375

Literatures (Medical) associated with Ustekinumab

01 Dec 2025·IMMUNOLOGIC RESEARCH

A patient with CVID-enteropathy successfully treated with ustekinumab

Article

Author: Grammatikos, Alexandros ; Marley, Fenella ; Lockett, Melanie ; Gompels, Mark

CVID (common variable immunodeficiency) is associated with a variety of gastrointestinal disorders including those mimicking Crohn's disease and ulcerative colitis. At present there is no clear trial data for the treatment of CVID enteropathy. There are no specific recommendations for treatment; however, it is commonly treated in a similar manner to inflammatory bowel disease, with corticosteroids, 5-aminosalicylates (5-ASA), azathioprine and anti-TNF therapy all being used. We describe the case of a 54-year-old with CVID-enteropathy presenting with diarrhoea and evidence of granulomatous inflammation on colonic biopsies. He was successfully treated with ustekinumab following failure/intolerance of prednisolone, 5-ASA and azathioprine. Features of CVID-enteropathy improved both clinically and histologically, with no evidence of serious treatment-related side effects.

01 Mar 2025·CLINICAL THERAPEUTICS

Treatment Persistence Among Anti-Tumor Necrosis Factor–experienced Patients With Ulcerative Colitis Switching to a Biologic With a Different Mode of Action or Cycling to Another Anti–Tumor Necrosis Factor Agent

Article

Author: Shah, Aditi ; Zhdanava, Maryia ; Boonmak, Porpong ; Kachroo, Sumesh ; Pilon, Dominic ; Godwin, Bridget ; Burbage, Sabree

PURPOSE:

In ulcerative colitis (UC), anti-tumor necrosis factor (TNF) agents often are first-line biologic therapy. Switching to a biologic with a different mode of action (ustekinumab and vedolizumab) or cycling to another anti-TNF agent (adalimumab, infliximab, and golimumab) is necessary if an initial anti-TNF fails. This study compared real-world persistence in patients with UC who switched to a biologic with a different mode of action or cycled with another anti-TNF after nonresponse to an anti-TNF.

METHODS:

Adults with UC treated with an anti-TNF, who switched or cycled (index date) between October 21, 2019, and March 02, 2022, were selected from the IQVIA PharMetrics® Plus database. Patients had ≥12 months of continuous insurance eligibility before the first anti-TNF without UC-indicated biologics or advanced therapies. During the 12 months before the index date (baseline period), patients had no other immune disorders and discontinued the first anti-TNF. Baseline characteristics were balanced using inverse probability of treatment weights. Persistence on the index biologic was defined as no therapy exposure gaps >120 days (ustekinumab, vedolizumab, and infliximab) or >60 days (adalimumab and golimumab) between days of supply. Composite end points were persistence while corticosteroid-free (<14 consecutive days of corticosteroid supply after day 90 post-index) and persistence while on monotherapy (no immunomodulators/nonindex biologics/advanced therapies). End points were assessed with weighted Kaplan-Meier and Cox proportional hazards models 12 months after the maintenance phase started.

FINDINGS:

The switch cohort included 488 patients (mean age: 41.4 years; 44.9% female), and the cycle cohort included 129 patients (mean age: 40.7 years; 43.8% female). At 12 months after the maintenance phase started, the proportions of persistent patients (switch cohort: 79.6%; cycle cohort: 64.9%) and persistent patients on monotherapy (switch cohort: 74.6%; cycle cohort: 48.0%) were significantly higher in the switch versus cycle cohort; the proportions of persistent patients while corticosteroid-free was also higher in the switch (60.1%) versus cycle cohort (49.3%) but was not significant. In the switch cohort, the rate of persistence was 1.92 times higher (hazard ratio [HR] = 1.92; 95% CI, 1.31-2.82), the rate of persistence while on monotherapy was 2.56 times higher (HR = 2.56; 95% CI, 1.86-3.53), and the rate of persistence and being corticosteroid-free was 1.31 times higher (HR = 1.31; 95% CI, 0.98-1.77) than in the cycle cohort.

IMPLICATIONS:

Patients with UC who switched from an anti-TNF agent to a biologic with a different mode of action were more persistent on treatment than patients who cycled to another anti-TNF agent. Findings may aid physicians whose patients experience treatment failure on the first anti-TNF agent.

01 Mar 2025·GASTROENTEROLOGY

A Head-to-Head Comparison of Risankizumab and Ustekinumab as Second-Line Therapy in Moderate to Severely Active Crohn’s Disease

Article

Author: Khanna, Reena ; Roshanov, Pavel S ; Roshanov, Pavel S.

380

News (Medical) associated with Ustekinumab

24 Feb 2025

·pipelinereview.com

Samsung Bioepis Announces US Launch of PYZCHIVA® (ustekinumab-ttwe), Biosimilar to Stelara

INCHEON, Korea I February 24, 2025 I Samsung Bioepis Co., Ltd. today announced that PYZCHIVA ® (ustekinumab-ttwe), a biosimilar to Stelara (ustekinumab), is now available in the United States. PYZCHIVA has been approved for the treatment of moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis. Through Samsung Bioepis’ commercialization partner Sandoz, PYZCHIVA is available to patients across US starting today in 45 mg/0.5 mL and 90 mg/mL pre-filled syringes, 130 mg/26 mL intravenous infusion single-dose vial, and 45 mg/0.5 mL subcutaneous vials. “The launch of PYZCHIVA is a significant milestone for both Samsung Bioepis and for millions of patients living with inflammatory conditions in the US. The expanded treatment options in the market would allow for reduced healthcare costs, ultimately contributing to a more sustainable healthcare system,” said Linda Y. MacDonald, Executive Vice President and Head of Global Commercial Division at Samsung Bioepis. “We remain steadfast in our commitment to serve patients in need through our continued innovation to make medicine more accessible.” Samsung Bioepis and Sandoz entered into a commercialization agreement for PYZCHIVA in September 2023 for the US. Samsung Bioepis remains responsible for development, registration, intellectual property, manufacturing and supply. In the US, the license period for PYZCHIVA will begin on February 22, 2025, according to the settlement and license agreement between Samsung Bioepis and Janssen Biotech Inc. Samsung Bioepis has a total of 11 biosimilars in its products and pipeline portfolio across immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. Currently, Samsung Bioepis has 10 biosimilars approved in the US and five commercially available. About PYZCHIVA® (ustekinumab-ttwe) injection, for subcutaneous (45 mg/0.5 mL and 90 mg/mL) or intravenous (130 mg/26 mL solution) use PYZCHIVA (ustekinumab-ttwe) is indicated for: SELECTED IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS PYZCHIVA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in PYZCHIVA. WARNINGS AND PRECAUTIONS Infections Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products. Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical studies included the following: Avoid initiating treatment with PYZCHIVA in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of PYZCHIVA in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with PYZCHIVA and discontinue PYZCHIVA for serious or clinically significant infections until the infection resolves or is adequately treated. Theoretical Risk for Vulnerability to Particular Infections Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections. Consider appropriate diagnostic testing (e.g., tissue culture, stool culture, as dictated by clinical circumstances). Pre-treatment Evaluation for Tuberculosis Evaluate patients for tuberculosis infection prior to initiating treatment with PYZCHIVA. Avoid administering PYZCHIVA to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis prior to administering PYZCHIVA. Consider anti-tuberculosis therapy prior to initiation of PYZCHIVA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving PYZCHIVA for signs and symptoms of active tuberculosis during and after treatment. Malignancies Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among subjects who received ustekinumab in clinical studies. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy. The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer. Monitor all patients receiving PYZCHIVA for the appearance of non-melanoma skin cancer. Closely follow patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue PYZCHIVA. Posterior Reversible Encephalopathy Syndrome (PRES) Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis and Crohn’s disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab product initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab products. Monitor all patients treated with PYZCHIVA for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue PYZCHIVA. Immunizations Prior to initiating therapy with PYZCHIVA, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with PYZCHIVA should avoid receiving live vaccines. Avoid administering BCG vaccines during treatment with PYZCHIVA or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving PYZCHIVA because of the potential risk for shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of PYZCHIVA may not elicit an immune response sufficient to prevent disease. Noninfectious Pneumonia Cases of interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases administration of corticosteroids. If diagnosis is confirmed, discontinue PYZCHIVA and institute appropriate treatment. Most common adverse reactions are: Please see Full Prescribing Information for PYZCHIVA ® (ustekinumab-ttwe) HERE , which includes the Boxed Warning, Medication Guide and Instructions for Use. About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X , LinkedIn . SOURCE: Samsung Bioepis

Drug ApprovalLicense out/inVaccineClinical Result

24 Feb 2025

·pipelinereview.com

Celltrion Receives EC Approval for Avtozma® (CT-P47), a Biosimilar to RoActemra® (tocilizumab)

INCHEON, South Korea I February 23, 2025 I Celltrion today announced that the European Commission (EC) has granted marketing authorization for Avtozma ® (CT-P47), a biosimilar referencing RoActemra ® (tocilizumab). Avtozma ® has been approved for all indications of its reference product, including moderate to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and giant cell arteritis (GCA). 1 The approval further strengthens Celltrion’s growing immunology portfolio. “Today’s approval of Avtozma ® , a biosimilar to RoActemra ® , marks a critical step in Celltrion’s mission to provide European healthcare systems with affordable, effective solutions for immunological disorders. By leveraging our integrated operations, we strengthen the stability of supply chains and enhance collaboration with European healthcare professionals,” said Taehun Ha, Senior Vice President and Head of Europe at Celltrion. “We are committed to delivering value-driven solutions tailored to the unique needs of the European market.” The EC approval on Avtozma ® was supported by a comprehensive data package and totality of evidence, including the results from a phase III study demonstrating biosimilarity between Avtozma ® and the reference product. The primary endpoint was met in terms of mean change from baseline in Disease Activity Score (DAS) using 28 joints (DAS28)-ESR at Week 12, and the final results supported comparability in secondary efficacy, pharmacokinetics (PK), safety and immunogenicity results between Avtozma ® and RoActemra ® . 2,3 Avtozma ® is Celltrion’s twelfth biosimilar product approved by the EC, following the approval of Remsima ® (intravenous infliximab), Remsima ® SC (subcutaneous infliximab), Yuflyma ® (adalimumab), SteQeyma ® (ustekinumab), Truxima ® (rituximab), Herzuma ® (trastuzumab), Vegzelma ® (bevacizumab), Omlyclo ® (omalizumab), Eydenzelt ® (aflibercept), Stoboclo ® and Osenvelt ® (denosumab). About CT-P47 Phase III Clinical Trial 2,3 This was a Phase III, randomised, active-controlled, double-blind trial to compare the efficacy and safety of Avtozma ® (CT-P47) and RoActemra ® (tocilizumab) in patients with moderate to severely active rheumatoid arthritis (RA). Therapeutic equivalence of CT-P47 and reference tocilizumab in treating RA was demonstrated and supported by comparable and sustained efficacy results up to Week 52. CT-P47 was also well tolerated with a safety profile comparable to reference tocilizumab, and no notable safety issue was identified following the single transition from reference tocilizumab to CT-P47 compared with maintenance groups up to Week 52. About Avtozma ® (CT-P47, biosimilar tocilizumab) Avtozma ® , containing the active ingredient tocilizumab, is a recombinant humanised monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Based on data from the global Phase III clinical trial, designed to evaluate the efficacy, pharmacokinetics, safety, and immunogenicity of Avtozma ® compared to the reference product 2,3 , Avtozma ® has been approved for all indications of its reference product, including moderate to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and giant cell arteritis (GCA). 1 Avtozma ® was also approved by the U.S. FDA in January 2025. About Celltrion Celltrion is a leading biopharmaceutical company that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people’s lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world’s first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media – LinkedIn , Instagram , X , and Facebook . SOURCE: Celltrion

Drug ApprovalPhase 3Clinical ResultBiosimilar

24 Feb 2025

·www.prnewswire.com

Biocon Biologics Launches Yesintek™ (ustekinumab-kfce) Biosimilar to Stelara® in the United States

BRIDGEWATER, N.J. and BENGALURU, India, Feb. 24, 2025 /PRNewswire/ -- Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), today announced that YESINTEK™ (ustekinumab-kfce) is now available to patients in the United States, and is one of the first Stelara® (ustekinumab) biosimilar market entrants in the country. Continue Reading YESINTEK is approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, increasing patient access to more cost-effective treatment options for use in the treatment of common chronic autoimmune diseases. YESINTEK will be available in all the same formulations currently provided by Stelara. The available presentations are 45 mg/0.5 mL PFS, 90 mg/mL PFS, 45 mg/0.5 mL vial, and 130 mg/26 mL vial. YESINTEK is approved for the treatment of common chronic autoimmune diseases. Post this Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said: "The launch of YESINTEK marks a significant step in our commitment to improving the lives of patients with inflammatory conditions and expanding access to high-quality biosimilars. It also represents our first product launch in the United States since becoming a fully integrated global biosimilars organization. We are excited to be among the first companies to introduce a high-quality, affordable biosimilar Ustekinumab to this patient population." Laura Wingate, Chief Education, Support & Advocacy Officer of the Crohn's & Colitis Foundation, said: "The burden of Crohn's disease and ulcerative colitis on patients' daily lives is substantial. This is a meaningful advancement for eligible chronic disease patients, who now have more treatment options available." YESINTEK will have commercial payor coverage at launch and also have a robust patient assistance program that includes benefits verification, copay support, among other services. The copay program is competitive with the originator offering and eligible patients that meet the program criteria may pay as little as $0. YESINTEK is a monoclonal antibody that disrupts IL-12 and IL-23 mediated signaling associated immune mediated diseases. Clinical studies showed that YESINTEK is a biosimilar to Stelara® and has similar pharmacokinetic, safety, efficacy and immunogenicity profile compared with Stelara®. YESINTEK received U.S. Food and Drug Administration (FDA) approval in December 2024. Josh Salsi, Head of North America, Biocon Biologics Inc., said: "For healthcare providers, switching to YESINTEK offers a seamless treatment experience covering the same indications and dosing options. Patients can feel confident that YESINTEK comes from Biocon Biologics, a company with extensive biosimilar expertise in immunology." For more information and resources, please visit . Health care professionals can access more information at . About YESINTEK The approval for YESINTEK (ustekinumab-kfce) was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that YESINTEK is highly similar to Stelara®. In a Phase 3 STELLAR-2 Study, YESINTEK was compared with Stelara® in patients with moderate-to-severe chronic Plaque Psoriasis. The study demonstrated that there were no clinically meaningful differences between YESINTEK and Stelara in terms of pharmacokinetics, safety, efficacy, and immunogenicity. INDICATIONS AND USAGE: YESINTEK is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: Moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy Active psoriatic arthritis (PsA) Moderately to severely active Crohn's Disease (CD) Moderately to severely active ulcerative colitis Pediatric patients 6 years and older with: Moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy Active psoriatic arthritis (PsA) CONTRAINDICATIONS Clinically significant hypersensitivity to ustekinumab or to any of the excipients in YESINTEK. WARNINGS AND PRECAUTIONS: Infections: Serious infections have occurred. Avoid starting YESINTEK during any clinically important active infection. If a serious infection or clinically significant infection develops, discontinue YESINTEK until the infection resolves. Theoretical Risk for Particular Infections: Serious infections from mycobacteria, salmonella and Bacillus Calmette-Guerin (BCG) vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Consider diagnostic tests for these infections as dictated by clinical circumstances. Tuberculosis (TB): Evaluate patients for TB prior to initiating treatment with YESINTEK. Initiate treatment of latent TB before administering YESINTEK. Malignancies: Ustekinumab may increase risk of malignancy. The safety of ustekinumab products in patients with a history of or a known malignancy has not been evaluated. Hypersensitivity Reactions: If an anaphylactic or other clinically significant hypersensitivity reactions occurs, institute appropriate therapy and discontinue YESINTEK. Posterior Reversible Encephalopathy Syndrome (PRES): If PRES is suspected, treat promptly and discontinue YESINTEK. Immunizations: Avoid use of live vaccines in patients during treatment with YESINTEK. Noninfectious Pneumonia: Cases of interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. If diagnosis is confirmed, discontinue YESINTEK and institute appropriate treatment. Please refer to full Prescribing Information for YESINTEK for more information. To report SUSPECTED ADVERSE REACTIONS, contact Biocon Biologics at 1-833-986-1468 or FDA at 1-800-FDA-1088 or . About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its 'lab to market' capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 12 biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. The Company has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website ; Follow us on X (formerly Twitter): @BioconBiologics and LinkedIn: Biocon Biologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: ; Follow-us on X (formerly Twitter) @bioconlimited and LinkedIn: Biocon for company updates. Forward-Looking Statements: Biocon This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release. YESINTEK is a registered trademark of Biocon Biologics Limited All other trademarks, registered or unregistered, are the property of their respective owners. SOURCE Biocon Biologics Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalPhase 3Clinical ResultImmunotherapyBiosimilar

100 Deals associated with Ustekinumab

External Link

KEGG	Wiki	ATC	Drug Bank
D09214	Ustekinumab	L04AC05	DB05679

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Colitis, Ulcerative	AU	Janssen-Cilag Pty Ltd.	28 Jul 2009
Crohn Disease	AU	Janssen-Cilag Pty Ltd.	28 Jul 2009
Arthritis, Psoriatic	EU	Janssen-Cilag International NV	15 Jan 2009
Arthritis, Psoriatic	IS	Janssen-Cilag International NV	15 Jan 2009
Arthritis, Psoriatic	LI	Janssen-Cilag International NV	15 Jan 2009
Arthritis, Psoriatic	NO	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active moderate	EU	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active moderate	IS	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active moderate	LI	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active moderate	NO	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active severe	EU	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active severe	IS	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active severe	LI	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active severe	NO	Janssen-Cilag International NV	15 Jan 2009
Plaque psoriasis	EU	Janssen-Cilag International NV	15 Jan 2009
Plaque psoriasis	IS	Janssen-Cilag International NV	15 Jan 2009
Plaque psoriasis	LI	Janssen-Cilag International NV	15 Jan 2009
Plaque psoriasis	NO	Janssen-Cilag International NV	15 Jan 2009
Ulcerative colitis, active moderate	EU	Janssen-Cilag International NV	15 Jan 2009
Ulcerative colitis, active moderate	IS	Janssen-Cilag International NV	15 Jan 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Juvenile Idiopathic Arthritis	Phase 3	US	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	AR	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	DK	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	FR	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	DE	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	IT	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	PL	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	ES	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	TR	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	GB	Janssen Research & Development LLC	30 Aug 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04549792 (CTgov)	Early Phase 1	Sjogren-Larsson Syndrome \| Ichthyosis	13	ustekinumab	szumlrzgiq(tmiscxkmbo) = oeqvwxgrui ktwuaeroes (dxazdvakoa, puueazszdz - jlnonaanon) View more	-	12 Feb 2025
NCT04882072 (CTgov)	Phase 3	Takayasu Arteritis	14	placebo+ustekinumab (Double-blind: Placebo)	usbqxylimg(fzijcxygny) = fjafffsvge lmswddssko (ngkiljcfig, mpsjtoixtb - asimyclkzq) View more	-	02 Dec 2024
				Ustekinumab (Double-blind: Ustekinumab)	usbqxylimg(fzijcxygny) = mqwtprcitl lmswddssko (ngkiljcfig, pcrlwtsqbw - pnpqvipkhx) View more
NCT04629196 (CTgov)	Phase 4	Crohn Disease	12	Ustekinumab (IV Weight-Based Induction Dose)	hgerjvjfkv(wrynwwelyp) = yvangnqsqg lhgcwmjawg (kkidbxhmyq, gvusvjmpnq - gedpriszjl) View more	-	05 Nov 2024
				Ustekinumab (Standard Subcutaenous Dose)	hgerjvjfkv(wrynwwelyp) = wicumdgvbd lhgcwmjawg (kkidbxhmyq, zchqctfaog - dbzrgiqcop) View more
UEGW2024	Not Applicable	Crohn Disease	-	Ustekinumab as 1st line biologic treatment	egsdetgkke(donmtmsldy) = 63.9% (108/169) of patients experienced adverse events gwrtwnfjre (wsnieauvum ) View more	-	13 Oct 2024
				Ustekinumab as 2nd line biologic treatment
NCT03942120 (K-STAR, Pubmed \| Inflamm Bowel Dis) Manual	Not Applicable	Crohn Disease Maintenance \| Induction	464	Ustekinumab	pvgjwzqmbv(evmqpekrli) = esmfcocrhc rzwihtuhxf (jxzqsxlzag ) View more	Positive	03 Aug 2024
				Ustekinumab (At week 52 to 66)	pvgjwzqmbv(evmqpekrli) = ozmbzovjkb rzwihtuhxf (jxzqsxlzag ) View more
NCT04093531 (CTgov)	Phase 1	Primary Sjögren's syndrome	12	ustekinumab	xbtjvcrawp(lrygrfbdwv) = thzmgvfrfj iilkqiuqbs (otyopmdapm, hlgmpmmnhh - bexbpggwir) View more	-	25 Jun 2024
DDW2024	Not Applicable	Colitis, Ulcerative	-	Ustekinumab	bxsgxxlgfm(csbtxpsvvi) = nkwfmbbgro lwnhnefurr (ljqqoupntf ) View more	-	21 May 2024
				Vedolizumab	bxsgxxlgfm(csbtxpsvvi) = hcpeczzsen lwnhnefurr (ljqqoupntf ) View more
DDW2024	Not Applicable	Crohn Disease	-	Ustekinumab	fblrtykxig(cbntehytus) = tujdytegsy xlgojijjku (ginnscgjsh ) View more	-	20 May 2024
NCT04089345 (Pubmed \| Clin Gastroenterol Hepatol) Manual	Phase 3	Pouchitis	22	ustekinumab intravenously at baseline (∼6mg/kg)	ovrlvtryvk(worbavwddz) = dscpnlrkzt yylpbeuwkd (xbdmtrbwth ) View more	Positive	14 May 2024
NCT03981744 (CTgov)	Phase 3	Dermatomyositis	51	placebo+ustekinumab (Placebo)	ibqxyanmdc(hepenhhpxf) = reuwnpykny qzobccwycp (vaqiaasijz, mbmogkaxbd - wpohovrvwp) View more	-	13 May 2024
				Ustekinumab (Ustekinumab)	ibqxyanmdc(hepenhhpxf) = weaydezaoc qzobccwycp (vaqiaasijz, pawqcrydtz - rszzdmqldc) View more

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