Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis)

To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis under actual status of use.

Start Date21 Oct 2019

Sponsor / Collaborator

Pfizer Inc.

NCT03885037

/ Active, not recruitingNot Applicable

Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Rheumatoid Arthritis)

To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against rheumatoid arthritis under actual status of use.

Start Date20 Mar 2019

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with Infliximab-QBTX

100 Translational Medicine associated with Infliximab-QBTX

100 Patents (Medical) associated with Infliximab-QBTX

Literatures (Medical) associated with Infliximab-QBTX

02 Jul 2024·EXPERT OPINION ON BIOLOGICAL THERAPY

Infliximab biosimilar GP1111: a review of 5 years’ post-approval experience

Review

Author: Huizinga, Thomas W. J. ; Dipasquale, Valeria ; Heyn, Jens ; Zabransky, Markus ; Romano, Claudio

INTRODUCTION:

Infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha, and GP1111 (Zessly®, Sandoz) is the most recently approved infliximab biosimilar in Europe. We reviewed the approval process and key evidence for GP1111, focusing primarily on the indications of rheumatoid arthritis (RA) and inflammatory bowel disease (IBD).

AREAS COVERED:

This narrative review discusses preclinical, clinical, and real-world data for GP1111.

EXPERT OPINION:

Results from the Phase III REFLECTIONS trial in patients with moderate-to-severe active RA despite methotrexate therapy confirmed the similarity in efficacy and safety between GP1111 and reference infliximab. Switching from reference infliximab to GP1111 in REFLECTIONS had no impact on efficacy or safety. Since the European approval of GP1111 in March 2018, real-world data have also confirmed the efficacy and safety of switching from another infliximab biosimilar to GP1111 in patients with RA and IBD. In addition, budget impact analysis of various sequential targeted treatments in patients with RA found that GP1111 was cost-effective when used early after failure of conventional synthetic disease-modifying antirheumatic drugs. Therefore, 5 years' post-approval experience with GP1111 in RA and IBD, and key clinical and real-world evidence, support the safety and efficacy of continued use of GP1111 in all infliximab-approved indications.

01 Dec 2023·Drug safety

Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch

Review

Author: Kottke, Andrea ; Cohen, Hillel P ; Kalsekar, Sameer ; Anjaneya, Pradeep ; Sagi, Sreedhar

BACKGROUND:

Biosimilars are additional treatment options that are approved based on robust analytical and clinical comparisons with their reference biologic. At the time of initial approval, the full safety profile of a biosimilar is inferred from the reference biologic. Nonetheless, there are still lingering concerns related to the long-term safety of biosimilars. Therefore, we reviewed the post-approval pharmacovigilance data for eight marketed biosimilars from one Marketing Authorization Holder (MAH) to summarize their safety experience in a real-world setting for up to 18 years since their first biosimilar launch.

METHODS:

Post-approval cumulative patient exposure and safety experience for eight Sandoz biosimilars [adalimumab (Hyrimoz^®), epoetin alfa (Binocrit^®), etanercept (Erelzi^®), filgrastim (Zarzio^®), infliximab (Zessly^®), pegfilgrastim (Ziextenzo^®), rituximab (Rixathon^®), and somatropin (Omnitrope^®)] was summarized based on the available pharmacovigilance data from Periodic Safety Update Reports (PSURs) and the corresponding health authority-authored PSUR assessment reports, where available, as of 31 January 2023. Exposure to all biosimilars was calculated in patient treatment days (PTD) except for rituximab, which was expressed in number of patient doses (PD).

RESULTS:

The combined post-approval cumulative exposure to seven out of the eight marketed Sandoz biosimilars was more than 1.3 billion PTD and for rituximab more than 1.8 million PD. Overall, a critical analysis of the cumulative safety data of all eight Sandoz biosimilar PSURs concluded that the overall benefit-risk profile of each remains favorable and is consistent with the respective reference biologics.

CONCLUSIONS:

This is one of the largest reviews of post-approval biosimilar pharmacovigilance data to date by one MAH. The real-world experience of all eight marketed Sandoz biosimilars for up to 18 years demonstrates that Sandoz biosimilars can be used as safely as their respective reference biologics. Therefore, patients and healthcare providers can be confident in the clinical benefit and safety of Sandoz biosimilars. It is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The long-term safety of biosimilars demonstrated here provides strong support for the concept of biosimilarity.

01 Mar 2023·Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver

Switching from SB2 to PF-06438179/GP1111 and back in inflammatory bowel disease: “The Superswitchers”

Letter

Author: Renna, Sara ; Casà, Angelo ; Mannino, Mariella ; Orlando, Ambrogio ; Grova, Mauro ; Macaluso, Fabio Salvatore

News (Medical) associated with Infliximab-QBTX

12 Mar 2025

·www.prnewswire.com

RedHill Biopharma Advances its Groundbreaking Late-Stage Crohn's Disease Program Building on Statistically Significant Positive RHB-104 Phase 3 Results

The planned innovative Phase 2 study of RHB-2041 will be the first ever clinical study in Crohn's Disease (CD) patients who are all MAP-positive, and will correlate mucosal healing with MAP2 infection eradication utilizing novel endpoints and imaging, pending Type C discussions on path to FDA approval, with FDA guidance expected in Q2/25 -- Patent protected until 2041, RHB-204 is a next generation anti-MAP therapy derivative of RHB-1043 which successfully met its groundbreaking Phase 3 study primary and secondary endpoints demonstrating a statistically significant 64% improvement in efficacy versus SoC and showed compelling mucosal healing data in CD patients who underwent colonoscopy. The inclusion of MAP-positive only patients in the planned study with RHB-204 is anticipated to demonstrate a more consistent benefit in the study population across all efficacy outcomes -- Based on insights from RHB-104's statistically significant positive Phase 3 study results, the improved formulation RHB-204 is designed to reduce pill burden and further enhance tolerability, safety and adherence, and along with the uniquely defined patient population (MAP-positive), allows for a study design with a small sample size and decisive endpoints, entailing lower study costs and expedited timeframe -- The role of MAP as a cause of CD, to be tested in this study, supports a paradigm-shifting new therapeutic approach for CD – focused on addressing the actual cause of the disease, not the symptoms -- The multibillion-dollar Crohn's disease market is expected to expand significantly, with sales in the key markets growing from $13.6 billion in 2024 to over $19 billion in 2033, presenting significant commercial potential for a new FDA approved therapy RALEIGH, N.C. and TEL-AVIV, Israel, March 12, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced plans to advance its groundbreaking late-stage program for Crohn's disease (CD) with initiation of an innovative Phase 2 study of RHB-204 in Mycobacterium avium subspecies paratuberculosis-positive (MAP+) moderate to severe CD, utilizing novel endpoints and the new gold standard in imaging techniques, pending Type C discussions on path to FDA approval with guidance from FDA anticipated next quarter. Patent protected until 2041, and with an expected pediatric orphan designation (subject to FDA approval to transfer from RHB-104), RHB-204, is a novel next generation improved formulation of Phase 3-stage RHB-104, designed to support enhanced tolerability, safety and adherence, with a 40% pill burden reduction, and thus potential better outcomes. In its groundbreaking positive Phase 3 study which met primary and secondary endpoints, RHB-104 demonstrated a 64% increase in efficacy versus SoC, superior remission as early as week 16, improving further at week 26 and continuing through week 52, and also showed compelling mucosal healing data in those patients who underwent colonoscopy. The Phase 2 study is expected to have primary endpoints of mucosal healing (considered a new gold standard in efficacy evaluation in Crohn's disease), MAP status and clinical remission, per FDA guidance following the positive Phase 3 CD study results with RHB-104. The RHB-204 study will be the first ever clinical trial in CD patients who are all MAP-positive, and will correlate mucosal healing with MAP eradication. Based on the successful RHB-104 Phase 3 study insights and specified endpoints, it is expected that the RHB-204 study could be efficiently conducted with a clearly defined and relatively small patient population, precise and decisive endpoints, and an expedited timeframe (with early efficacy indications potentially at just 16 weeks), reducing substantially the anticipated program costs. Clinical study material has already been manufactured and is in place ready for study implementation. The CD market is expected to expand significantly over the 2024–2033 forecast period, with sales in the United States, Japan, and five major European markets, growing from $13.6 billion to $19.1 billion at a compound annual growth rate (CAGR) of 3.87%4. With significant numbers of treatment failures and approximately 1.6 million diagnosed prevalent cases of CD diagnosed globally last year4, there is a strong need for effective new CD therapies. Where applicable, the Company intends to explore the potential for additional regulatory process designations, such as breakthrough therapy designation and fast track designations that may provide additional exclusivity or potential for priority review vouchers, where applicable. Dr. David Y. Graham, Professor of Medicine and Molecular Virology and Microbiology at Baylor College of Medicine, said: "Up to 40% of patients fail to respond to anti-TNF treatment, and over time up to 50% of responders lose response and have disease flare-ups. In addition to the unmet medical need for alternative therapeutic approaches, most of the existing drugs for CD are both expensive and are intravenously administered, further adding to the treatment cost burden. Moreover, several of these existing therapies have known safety issues, including Black Box Warnings, so we believe a safe and effective orally administered therapy would be a very convenient and welcome addition. Based on the safety and efficacy data with concomitant anti-TNFs, immunomodulators and steroids demonstrated in RedHill's initial RHB-104 Phase 3 U.S. study, the development of RHB-204 may provide an expedited route to a safe, oral, stand-alone or combination therapy." "Advances in diagnostic technology have led to increasingly higher identification of MAP in Crohn's diseases patients5," said Gilead Raday, Chief Operating Officer and Head of R&D at RedHill. "Utilizing gold standard imaging technology to provide clear and unambiguous efficacy results, the study is designed to include only MAP positive CD patients and is expected to increase the study's power, potentially allowing to demonstrate the benefits of RHB-204 anti-MAP therapy in a relatively small sample size, over and above the promising efficacy observed in the positive Phase 3 study results of RHB-104's in all-comer CD patients. RedHill is actively pursuing partnering and collaborations for this program, including ongoing discussions with non-dilutive external funding sources, which may pave the way to a much-needed new therapeutic modality for CD, focused on addressing a suspected cause of the disease, as opposed to just its symptoms." The randomized, double-blind, placebo-controlled 331-patient Phase 3 study of RHB-104 in active Crohn's disease met its primary and secondary endpoints, showing RHB-104 standard of care (SoC) to be 64% more effective than SoC alone, was published in the peer-reviewed journal, Antibiotics6. In the global study, conducted across 92 sites, a total of 166 patients were randomized to receive RHB-104 plus SoC and 165 to placebo plus SoC. Data for the primary endpoint, clinical remission at week 26, shows, with high statistical significance, that 36.7% (61/166) of RHB-104 patients achieved clinical remission at week 26 vs. 22.4% (37/165) of placebo patients (p = 0.0048). In the secondary endpoint of mucosal healing, endoscopy was performed in a group of 35 patients who volunteered to undergo colonoscopy, with results showing meaningful improvement in endoscopic healing (Simple Endoscopic Score for Crohn's Disease (SES-CD)) at week 26 (statistically significant at 25% decrease with similar trend at 50% decrease), despite the small sample size. Further corroborating these results was the statistically significantly marked and continuous decline of inflammatory marker, fecal calprotectin (FCP) - an accepted surrogate for mucosal healing - in the RHB-104 active arm from baseline through week 52 in patients with high calprotectin at baseline. RHB-104 was found to be generally safe and well tolerated, with adverse event reporting similar to placebo. Full results are available in the publication. About Crohn's Disease: Crohn's disease (CD) is a form of Inflammatory Bowel Disease (IBD) causing inflammation of digestive tract tissue that can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition. CD can be highly debilitating and remains a serious burden for both patients and healthcare systems: destroying quality of life and even leading to life-threatening complications. There is no known cure for Crohn's disease. According to the Cleveland Clinic, experts estimate that more than three-quarters of a million Americans and approximately 6-8 million people globally have Crohn's disease Commonly used FDA approved therapies in the treatment of CD include: Abbvie's Humira® (adalimumab), Janssen's Remicade® (infliximab) and Stelara® (Ustekinumab), BMS's Zeposia® (ozanimod) and Pfizer's Xeljanz® (tofacitinib). About RHB-204 RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, at specific doses designed to safely and effectively treat MAP+-related Crohn's disease. Patent protected until at least 2041, and with an expected pediatric orphan designation (subject to FDA approval to transfer from RHB-104), RHB-204 is a next-generation formulation of RHB-104 with an optimized formulation for the treatment of CD. It contains the same three antimicrobial agents with potent intracellular, anti-mycobacterial and anti-inflammatory properties, and with an optimized dosing profile, RHB-204 provides the potential for enhanced tolerability, safety and compliance with a 40% pill burden reduction. RHB-204 is supported by a strong foundation of clinical data from the positive safety and efficacy results achieved in the Phase 3 study of RHB-104 in CD, with its potential further demonstrated using mucosal healing imaging, considered to be the gold standard for efficacy evaluation in CD. Originally developed for the treatment of pulmonary NTM disease caused by MAC, RHB-204 was granted FDA Fast Track and Orphan Drug Designation, in addition to QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. post-approval U.S. market exclusivity to a potential total of 12 years. RHB-204 has additionally been granted EU Orphan Designation, providing eligibility for 10 years EU post-approval market exclusivity. RedHill has protection for RHB-204, and its use in treating pulmonary MAC disease, until 2041. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA approved gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults7. RedHill's key clinical late-stage development programs include: (i) RHB-204 with a planned Phase 2 study for Crohn's disease and Phase 3-stage for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iii) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program study in prostate cancer in combination with Bayer's darolutamide; (iv) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (v) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America. More information about the Company is available at / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include, among others, statements regarding the potential development of RHB-204 for Crohn's disease. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the risk that the development of RHB-204 for Crohn's disease may not be completed and if completed may not be successful; the risk that the Company will not benefit from its agreement with Hyloris as currently anticipated; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk of market and other conditions and that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 8, 2024. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma +972-54-6543-112 [email protected] Category: R&D 1 RHB-204 is an investigational new drug, not available for commercial distribution in the United States. 2 Mycobacterium avium subspecies paratuberculosis 3 RHB-104 is an investigational new drug, not available for commercial distribution in the United States. 4 DataMonitor - Disease Analysis: Crohn's Disease, September 2024 5 Bull, J Clin Microbiol, 2003 and Shafran, Dig Dis Sci, 2002 6 Graham DY, et al. Randomized, Double-Blind, Placebo-Controlled Study of Anti-Mycobacterial Therapy (RHB-104) in Active Crohn's Disease. Antibiotics (Basel). 2024 Jul 25;13(8):694. doi: 10.3390/antibiotics13080694. PMID: 39199994; PMCID: PMC11350828. 7 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . Logo - SOURCE RedHill Biopharma Ltd. 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Clinical ResultPhase 3Fast TrackPhase 2Orphan Drug

14 Mar 2024

·www.prnewswire.com

Psoriasis in America - Insights into Psoriasis Patient Demographics, Quality of Life, Information-seeking Behaviors, HCP Engagement and Treatment Experiences

DUBLIN, March 14, 2024 /PRNewswire/ -- The "Psoriasis in America 2023: Understanding the Psoriasis Patient Experience" report has been added to ResearchAndMarkets.com's offering. Approximately 7.5 million people in the United States have psoriasis. This Psoriasis in America report provides a comprehensive look at life for those living with psoriasis. Using detailed quantitative data, it gives a full picture of the psoriasis patient experience - from symptoms to treatment to HCP relationships to quality of life - so you can make informed, strategic decisions, identify opportunities, and understand potential challenges. The report offers an in-depth look at the psoriasis patient experience. This large-scale, patient-reported data leverages vital quantitative insights essential to understanding key touchpoints in the psoriasis patient journey, including condition management, HCP engagement, quality of life, treatment experience and satisfaction, and much more. This report lifts the curtain on life with psoriasis, giving stakeholders an actionable look at the behaviors, attitudes, perceptions, needs, and experiences of people living with the condition. Data can be used to inform strategic decisions, including product communications, competitive assessments, concept development, landscape analyses, patient journey overlays, and forecasting inputs. This report also addresses important questions that stakeholders may not even know to ask while offering valuable insights into must-have patient-reported data points not available anywhere else. Add-on custom data analysis opportunities are also available for an additional cost - please see the report following purchase for more information. The analyst reaches millions of people through its portfolio of 45+ condition-specific online health communities - including PlaquePsoriasis.com - to provide information, connection, and support to patients and caregivers in the U.S. This report includes a deep-dive into: Psoriasis patient demographics Age, gender, ethnicity, marital status, children, employment status, income, location, insurance, and other health conditions Impact of psoriasis on quality of life Severity, impact on quality of life, symptoms experienced, and what patients wish others better understood Information-seeking behaviors Information sources used, plus topics of interest HCP engagement Primary HCP seen for condition, satisfaction with HCP, and discussion about brands aware of/not used Psoriasis treatment awareness and experiences Aided awareness of specific treatments, treatment experience, satisfaction with current treatments, perceived control with current treatment plan, and interest/participation in clinical trials Key questions answered in this report: To what extent do people say psoriasis impacts their overall quality of life? What's the average number of flares in the past year? What do patients wish others understood about psoriasis? What percentage of patients see a specialist for psoriasis treatment? What treatments have the highest aided brand awareness among patients? What percentage of patients use a biologic? How many patients feel their psoriasis is well-controlled on their current treatment plan? What percentage of patients are likely to switch or add new treatments in the next six months? What medications have patients discussed with their HCP? What are the top online resources people with psoriasis use to find information? What kinds of content and information do patients search for? What percentage of patients search for information on treatment options? Methodology Psoriasis in America consists of: A 20-minute online quantitative survey, covering demographics, comorbidities, quality of life/impact, HCP interactions, as well as treatment awareness, experiences, and discussions Qualitative patient insights from open-ended responses Additional details: Fielded: January 16, 2023 to April 14, 2023 Convenience sample of 490 respondents diagnosed with psoriasis Respondents are age 18+, living in the U.S., and are recruited from proprietary online health communities and recruiting partners Key Topics Covered: Respondent Demographics Research Highlights Condition Status and Quality of Life Severity and Exacerbations Symptoms Experienced Impact on Quality of Life Qualitative Patient Insights Information-Seeking Behaviors Resources Used to Manage Health Types of Content/Information Sought Treatment Awareness and Experiences Primary HCP Seen for Psoriasis Care Aided Brand Awareness of Treatments Treatment Usage Condition Control on Current Treatment and Clinical Trial Interest Treatment Discussions with HCP Appendix with All Data Charts and Distributions Brands and treatments mentioned in this report include: Topical corticosteroid (such as hydrocortisone) BRYHALIT (halobetasol propionate) lotion DesOwen (desonide) SERNIVOT (betamethasone dipropionate) SORILUXT Foam (calcipotriene) TACLONEX (calcipotriene and betamethasone) TAZORAC (tazarotene) VECTICAL (calcitriol) VTAMA (tapinarof) ZITHRANOLT-RR (anthralin) ZORYVET (roflumilast) Acitretin (SORIATANE) ARAVA (leflunomide) Azathioprine (such as IMURAN, AZASAN) Cyclosporine (such as Sandimmune, NEORAL, RESTASIS) Methotrexate (eg, Rheumatrex), also sometimes given as an injection OTEZLA (apremilast) PLAQUENIL (hydroxychloroquine) RINVOQ (upadacitinib) SOTYKTUT (deucravacitinib) Sulfasalazine (Azulfidine) XELJANZ/XELJANZ XR (tofacitinib citrate) AMJEVITAT (adalimumab-atto) Hide until launched in US AVSOLA (infliximab-axxq) CIMZIA (certolizumab) COSENTYX (secukinumab) CYLTEZO (adalimumab-adbm) Hide until launched in US ENBREL (etanercept) ERELZIT (etanercept-szzs) Hide until launched in US HULIO (adalimumab-fkjp) Hide until launched in US HUMIRA (adalimumab) HYRIMOZ (adalimumab-adaz) Hide until launched in US ILUMYAT (tildrakizumab-asmn) INFLECTRA (infliximab-dyyb) IXIFIT (infliximab-qbtx) Hide until launched in US ORENCIA (abatacept) REMICADE (infliximab) RENFLEXIST (infliximab-abda) SIMPONI (golimumab) SIMPONI ARIA (golimumab for infusion) SILIQT (brodalumab) SKYRIZI (risankizumab-rzaa) STELARA (ustekinumab) TALTZ (ixekizumab) TREMFYA (guselkumab) For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

19 Feb 2024

·www.pharmaceutical-technology.com

Celltrion’s Remsima SC for IBD gains approval in Canada

In LIBERTY trials, Remsima SC was shown to be superior to placebo in achieving clinical remission and endoscopic response. Credit: Emily frost / Shutterstock.com. Celltrion Healthcare Canada has announced that its Remsima SC, a subcutaneous version of its infliximab biosimilar, has obtained approval for use as maintenance therapy for inflammatory bowel disease (IBD). The treatment is now approved by Health Canada for patients with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). The approval was based on positive clinical data from the LIBERTY UC and LIBERTY CD clinical trials. Both studies demonstrated the safety and efficacy of Remsima SC as a maintenance treatment in people with UC and CD over 54 weeks. Remsima SC showed superiority in achieving the primary endpoints of clinical remission and endoscopic response versus placebo. See Also: Pfizer’s VELSIPITY receives EC approval for ulcerative colitis INV-347 by Inversago Pharma for Obesity: Likelihood of Approval This was observed in patients receiving maintenance therapy after induction with the intravenous formulation of infliximab. The safety profile of Remsima SC during the maintenance period was comparable to that of the placebo in both studies. No new safety concerns were reported, highlighting the treatment’s safety for long-term use. Remsima SC works by blocking the action of tumour necrosis factor-alpha, often overproduced in autoimmune ailments, which leads to the immune system attacking healthy body parts. The intravenous formulation of infliximab biosimilar was the first monoclonal antibody biosimilar to be approved globally. It is currently indicated for nine autoimmune diseases, including UC and CD. The biosimilar was first approved by the European Commission as REMSIMA in September 2013 and subsequently launched in major European countries in early 2015. With the latest Health Canada approval, Remsima SC is now an option for patients in the country with rheumatoid arthritis, UC and CD, offering a subcutaneous route of administration for convenience and ease in treatment management. Celltrion Healthcare Canada managing director Jungyong Shin stated: “The availability of an infliximab treatment option […] in a subcutaneous delivery is an advancement for the patients and healthcare providers in Canada. “Patients now have the opportunity to choose how and where they receive infliximab treatment: in an infusion centre, at a physician’s office and now with Remsima SC, the option to receive treatment at home – providing more flexibility and freedom of choice.”

Drug Approval

100 Deals associated with Infliximab-QBTX

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KEGG	Wiki	ATC	Drug Bank
-	-	L04AB02	DB00065

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Perianal fistula due to Crohn's disease	Australia	Pfizer Australia Pty Ltd.	27 Sep 2024
Uveitis	Japan	Pfizer Inc.	22 Apr 2020
Pediatric Ulcerative Colitis	United States	Pfizer Manufacturing Ireland Unlimited Co.	16 Jan 2020
Erythrodermic psoriasis	Japan	Pfizer Inc.	02 Jul 2018
Pustular psoriasis	Japan	Pfizer Inc.	02 Jul 2018
Psoriasis	European Union	Sandoz GmbH	18 May 2018
Psoriasis	Iceland	Sandoz GmbH	18 May 2018
Psoriasis	Liechtenstein	Sandoz GmbH	18 May 2018
Psoriasis	Norway	Sandoz GmbH	18 May 2018
Ankylosing Spondylitis	United States	Pfizer Manufacturing Ireland Unlimited Co.	13 Dec 2017
Arthritis, Psoriatic	United States	Pfizer Manufacturing Ireland Unlimited Co.	13 Dec 2017
Colitis, Ulcerative	United States	Pfizer Manufacturing Ireland Unlimited Co.	13 Dec 2017
Crohn Disease	United States	Pfizer Manufacturing Ireland Unlimited Co.	13 Dec 2017
Pediatric Crohn's Disease	United States	Pfizer Manufacturing Ireland Unlimited Co.	13 Dec 2017
Plaque psoriasis	United States	Pfizer Manufacturing Ireland Unlimited Co.	13 Dec 2017
Rheumatoid Arthritis	United States	Pfizer Manufacturing Ireland Unlimited Co.	13 Dec 2017

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02222493 (REFLECTIONS B537-02, Pubmed \| BioDrugs) Manual	Phase 3	Rheumatoid Arthritis	650	infliximab+methotrexate+PF-06438179	chrnlvqmqj(covzpvgpcl) = pjrenzpscd mqljpfmwng (rrgdohgnug ) View more	Similar	01 Apr 2020
NCT02222493 (REFLECTIONS B537-02, Pubmed \| RMD Open)	Phase 3	Rheumatoid Arthritis	650	PF-06438179/GP1111	jwjenscyfg(nfrklfklkp) = pqmegzfwud msuekguxjg (hqxgobkujd )	Positive	01 Jan 2019
				European reference infliximab	jwjenscyfg(nfrklfklkp) = kucioabbgv msuekguxjg (hqxgobkujd )
ACR2017	Not Applicable	Rheumatoid Arthritis	-	SB2	dmvwscozoq(gljwfubqme) = rmcewfkcox ulnilhxsdi (wkgzoshuwh )	-	07 Nov 2017
				Reference Infliximab	dmvwscozoq(gljwfubqme) = vclifspasd ulnilhxsdi (wkgzoshuwh )

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