{"id":"biosimilar-infliximab","safety":{"commonSideEffects":[{"rate":"10–15","effect":"Infections (including serious infections)"},{"rate":"5–10","effect":"Infusion reactions"},{"rate":"5–10","effect":"Headache"},{"rate":"5–8","effect":"Nausea"},{"rate":"0.5–2","effect":"Tuberculosis reactivation"},{"rate":"1–3","effect":"Opportunistic infections"},{"rate":"5–10","effect":"Injection site reactions"}]},"_chembl":{"chemblId":"CHEMBL1201581","moleculeType":"Antibody"},"_fixedAt":"2026-03-30T14:20:03.443057","_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Infliximab is a chimeric monoclonal antibody that binds with high affinity to soluble and membrane-bound TNF-α, preventing its interaction with TNF receptors on immune cells and endothelial cells. This blocks the inflammatory cascade driven by TNF-α, reducing production of other pro-inflammatory cytokines and adhesion molecules. As a biosimilar, it is bioequivalent to the reference infliximab product (Remicade) and has the same mechanism of action.","oneSentence":"Biosimilar infliximab is a monoclonal antibody that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), reducing inflammatory signaling.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:21:03.059Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Rheumatoid arthritis"},{"name":"Crohn's disease"},{"name":"Ulcerative colitis"},{"name":"Ankylosing spondylitis"},{"name":"Psoriatic arthritis"},{"name":"Plaque psoriasis"},{"name":"Behçet's disease"}]},"_fixedFields":["pubmed(201)","modality→Monoclonal Antibody"],"trialDetails":[{"nctId":"NCT02998398","phase":"","title":"Evaluation of the Switch From the Original Infliximab to Its Biosimilar in Daily Practice at Cochin Hospital","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2015-10","conditions":"Rheumatoid Arthritis, Spondyloarthritis, Crohn's Disease","enrollment":262},{"nctId":"NCT03885037","phase":"","title":"Infliximab Biosimilar for Intravenous Drip Infusion 100 mg \"Pfizer\" Drug Use Investigation (Rheumatoid Arthritis)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2019-03-20","conditions":"Rheumatoid Arthritis","enrollment":77},{"nctId":"NCT02829424","phase":"PHASE4","title":"Multicenter Randomized Double Blind Controlled-study to Assess the Potential of Methotrexate Versus Placebo to Improve and Maintain Response to Anti TNF- Alpha Agents in Adult Patients With Moderate to Severe Psoriasis","status":"TERMINATED","sponsor":"Assistance Publique Hopitaux De Marseille","startDate":"2017-01-23","conditions":"Psoriasis","enrollment":78},{"nctId":"NCT05424926","phase":"","title":"Sub-cutaneous Infliximab in Inflammatory Rheumatic Disease","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2023-02-24","conditions":"Rheumatoid Arthritis, Spondyloarthritis, Psoriatic Arthritis","enrollment":22},{"nctId":"NCT03885089","phase":"","title":"Infliximab Biosimilar for Intravenous Drip Infusion 100 mg \"Pfizer\" Drug Use Investigation (Psoriasis)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2019-10-21","conditions":"Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis","enrollment":10},{"nctId":"NCT05168475","phase":"PHASE2","title":"Biologics in Refractory Vasculitis: A Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis","status":"TERMINATED","sponsor":"Cambridge University Hospitals NHS Foundation Trust","startDate":"2021-07-14","conditions":"Giant Cell Arteritis, Takayasu Arteritis, Cogan Syndrome","enrollment":22},{"nctId":"NCT05796245","phase":"","title":"A Study to Learn About the Study Medicine Called Infliximab (Genetical Recombination)[Infliximab Biosimilar 3] in People With Rheumatoid Arthritis, Ulcerative Colitis, Crohn's Disease, or Psoriasis","status":"COMPLETED","sponsor":"Pfizer","startDate":"2023-12-01","conditions":"Arthritis, Rheumatoid, Colitis, Ulcerative, Crohn Disease","enrollment":2207},{"nctId":"NCT03884439","phase":"","title":"Infliximab Biosimilar \"Pfizer\" Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2019-03-18","conditions":"Crohn's Disease, Ulcerative Colitis","enrollment":428},{"nctId":"NCT01848028","phase":"","title":"PsoBest - The German Psoriasis Registry","status":"RECRUITING","sponsor":"Universitätsklinikum Hamburg-Eppendorf","startDate":"2008-01","conditions":"Psoriasis, Psoriatic-arthritis","enrollment":3500},{"nctId":"NCT03445845","phase":"PHASE4","title":"Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Saint Etienne","startDate":"2018-12-14","conditions":"Axial Spondyloarthritis","enrollment":300},{"nctId":"NCT06591273","phase":"PHASE1, PHASE2","title":"Efficacy and Safety of Infliximab Biosimilar in Treatment of Moderate to Severe Psoriasis; A Single-arm Clinical Trial","status":"ACTIVE_NOT_RECRUITING","sponsor":"Services Institute of Medical Sciences, Pakistan","startDate":"2023-11-06","conditions":"Moderate to Severe Chronic Plaque Psoriasis","enrollment":104},{"nctId":"NCT06064864","phase":"NA","title":"Efficacy and Safety of Formulation Switching Between SC Infliximab and IV Infliximab in Patients With CD","status":"RECRUITING","sponsor":"Asan Medical Center","startDate":"2023-10-09","conditions":"Crohn's Disease","enrollment":100},{"nctId":"NCT01965132","phase":"","title":"Korean College of Rheumatology Biologics and Targeted Therapy Registry","status":"RECRUITING","sponsor":"Seoul National University Hospital","startDate":"2012-12-01","conditions":"Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis","enrollment":10000},{"nctId":"NCT03704363","phase":"PHASE3","title":"BackToBasic: Infliximab in Chronic Low Back Pain and Modic Changes","status":"COMPLETED","sponsor":"Oslo University Hospital","startDate":"2018-12-12","conditions":"Low Back Pain","enrollment":128},{"nctId":"NCT05663268","phase":"EARLY_PHASE1","title":"Efficacy and Safety of Infliximab Biosimilar in the Treatment of Resistant Hidradenitis Suppurativa","status":"COMPLETED","sponsor":"Services Institute of Medical Sciences, Pakistan","startDate":"2022-10-01","conditions":"Hidradenitis Suppurativa","enrollment":37},{"nctId":"NCT06043752","phase":"PHASE4","title":"Efficacy and Safety of Infliximab Biosimilar Remsima in Psoriasis","status":"COMPLETED","sponsor":"Ghurki Trust and Teaching Hospital","startDate":"2022-03-10","conditions":"Psoriasis","enrollment":51},{"nctId":"NCT03266471","phase":"","title":"Cytokines and Genes in Therapeutic Response in Crohn's Disease","status":"COMPLETED","sponsor":"Vanderbilt University Medical Center","startDate":"2017-10-13","conditions":"Inflammatory Bowel Diseases","enrollment":96},{"nctId":"NCT05719389","phase":"","title":"EFFICACY AND SAFETY OF S.C. INFLIXIMAB IN PATIENTS SWITCHED FROM I.V. FORMULATION OF INFLIXIMAB","status":"UNKNOWN","sponsor":"IRCCS San Raffaele","startDate":"2022-09-14","conditions":"Inflammatory Bowel Diseases, Rheumatologic Disease","enrollment":250},{"nctId":"NCT02925338","phase":"","title":"National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life","status":"COMPLETED","sponsor":"Pfizer","startDate":"2016-10-19","conditions":"Crohn Disease, Ulcerative Colitis, Rheumatoid Arthritis","enrollment":1431},{"nctId":"NCT03662919","phase":"","title":"One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study","status":"COMPLETED","sponsor":"Biogen","startDate":"2018-07-02","conditions":"Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic","enrollment":2274},{"nctId":"NCT05164198","phase":"PHASE4","title":"REduCed Dose of TNFi in Patients With Ankylosing SpondyliTis (RECAST)","status":"UNKNOWN","sponsor":"Hanyang University Seoul Hospital","startDate":"2022-01-15","conditions":"Ankylosing Spondylitis, Axial Spondyloarthritis","enrollment":448},{"nctId":"NCT03890445","phase":"","title":"Real-world Study of Anti-TNFa Treatment Regimes of Hyrimoz or Zessly in Patients With Crohn´s Disease","status":"COMPLETED","sponsor":"Sandoz","startDate":"2019-06-24","conditions":"Crohn´s Disease","enrollment":63},{"nctId":"NCT03452501","phase":"","title":"Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients","status":"COMPLETED","sponsor":"Hikma Pharmaceuticals LLC","startDate":"2018-08-26","conditions":"Inflammatory Bowel Diseases, Crohn Disease, Fistulizing Crohn's Disease","enrollment":157},{"nctId":"NCT03729674","phase":"","title":"Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs","status":"UNKNOWN","sponsor":"McGill University Health Centre/Research Institute of the McGill University Health Centre","startDate":"2018-11-26","conditions":"Rheumatoid Arthritis, Ankylosing Spondylitis, Ulcerative Colitis","enrollment":800},{"nctId":"NCT02728934","phase":"","title":"Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis","status":"COMPLETED","sponsor":"Janssen Scientific Affairs, LLC","startDate":"2016-02-25","conditions":"Arthritis, Rheumatoid","enrollment":1279},{"nctId":"NCT03348046","phase":"","title":"Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan","status":"COMPLETED","sponsor":"Hikma Pharmaceuticals LLC","startDate":"2017-03-23","conditions":"Rheumatoid Arthritis","enrollment":22},{"nctId":"NCT02539368","phase":"","title":"Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease","status":"COMPLETED","sponsor":"Pfizer","startDate":"2015-04-22","conditions":"Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn's Disease","enrollment":2565},{"nctId":"NCT02605642","phase":"","title":"Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade","status":"COMPLETED","sponsor":"Pfizer","startDate":"2015-09-10","conditions":"Rheumatoid Diseases, Rheumatoid Arthritis, Ankylosing Spondylitis","enrollment":351},{"nctId":"NCT03016260","phase":"","title":"RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFα BIologicals in Rheumatoid Arthritis","status":"TERMINATED","sponsor":"TcLand Expression S.A.","startDate":"2016-12","conditions":"RheumatoId Arthritis","enrollment":250},{"nctId":"NCT03775824","phase":"","title":"Faecal Analyses in Rheumatoid Arthritis Therapy","status":"COMPLETED","sponsor":"Region Skane","startDate":"2016-08-01","conditions":"Rheumatoid Arthritis","enrollment":50},{"nctId":"NCT02762838","phase":"PHASE3","title":"Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis","status":"COMPLETED","sponsor":"Biocad","startDate":"2016-01","conditions":"Rheumatoid Arthritis","enrollment":426},{"nctId":"NCT03308357","phase":"","title":"Comparison of the Performance of SB2-Infliximab With Originator Infliximab in the Measure of Serum Concentrations in Serum","status":"UNKNOWN","sponsor":"The Alfred","startDate":"2017-10","conditions":"Inflammatory Bowel Diseases","enrollment":6},{"nctId":"NCT02148640","phase":"PHASE4","title":"The NOR-SWITCH Study","status":"COMPLETED","sponsor":"Diakonhjemmet Hospital","startDate":"2014-10","conditions":"Rheumatoid Arthritis, Spondyloarthritis, Psoriatic Arthritis","enrollment":482},{"nctId":"NCT01936181","phase":"PHASE3","title":"A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy","status":"COMPLETED","sponsor":"Samsung Bioepis Co., Ltd.","startDate":"2013-08","conditions":"Rheumatoid Arthritis","enrollment":584},{"nctId":"NCT01571219","phase":"PHASE3","title":"An Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1","status":"COMPLETED","sponsor":"Celltrion","startDate":"2012-03","conditions":"Rheumatoid Arthritis","enrollment":302},{"nctId":"NCT03192878","phase":"","title":"Infliximab Biosimilar in Takayasu's Arteritis","status":"UNKNOWN","sponsor":"Ospedale San Raffaele","startDate":"2017-03-01","conditions":"Takayasu Arteritis","enrollment":30},{"nctId":"NCT02452151","phase":"PHASE4","title":"\"Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial\"","status":"UNKNOWN","sponsor":"Onze Lieve Vrouwe Gasthuis","startDate":"2015-08","conditions":"Colitis, Ulcerative, Crohn's Disease","enrollment":300},{"nctId":"NCT01571206","phase":"PHASE1","title":"An Extension Study to Demonstrate the Equivalence of Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1","status":"COMPLETED","sponsor":"Celltrion","startDate":"2012-03","conditions":"Ankylosing Spondylitis","enrollment":174}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":201,"recentPublications":[{"date":"2026 Dec","pmid":"41811347","title":"Real-world clinical, safety, and economic evaluation of infliximab biosimilar adoption for crohn's disease.","journal":"Journal of medical economics"},{"date":"2025","pmid":"41458195","title":"Safety outcomes in 2132 Danish patients with inflammatory arthritis treated with biosimilar infliximab (GP1111) in routine care.","journal":"Therapeutic advances in musculoskeletal disease"},{"date":"2025 Nov 19","pmid":"41257895","title":"A retrospective, multinational, cross-sectional survey of real-world outcomes for patients with axial spondyloarthritis receiving subcutaneous infliximab.","journal":"BMC rheumatology"},{"date":"2025 Oct 16","pmid":"41105812","title":"Effectiveness of an Infliximab Biosimilar vs. Originator in Inflammatory Bowel Diseases: A Noninferiority Nationwide Study From the epi-IIRN.","journal":"Journal of clinical gastroenterology"},{"date":"2025 Aug 31","pmid":"40895383","title":"Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX-SIRIUS STUDY I (the IFX-SIRIUS STUDY II): A clinical, ultrasound, and biomarker-based effectiveness after discontinuation and reinitiation of biosimilar infliximab.","journal":"Global health & medicine"}],"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Remsima®","Inflectra","Remsima"],"phase":"marketed","status":"active","brandName":"Biosimilar Infliximab","genericName":"Biosimilar Infliximab","companyName":"Hikma Pharmaceuticals LLC","companyId":"hikma-pharmaceuticals-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Biosimilar infliximab is a monoclonal antibody that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), reducing inflammatory signaling. Used for Rheumatoid arthritis, Crohn's disease, Ulcerative colitis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}