{"id":"infliximab-infliximab-biosimilar-3","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Live vaccines","action":"Avoid","effect":"Decreased vaccine response"},{"drug":"Bacillus Calmette-Guérin (BCG) vaccine","action":"Avoid","effect":"Decreased vaccine response"},{"drug":"Anakinra","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Abatacept","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Rituximab","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Tofacitinib","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Omalizumab","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Vaccines (non-live)","action":"Monitor","effect":"Unknown"},{"drug":"Azathioprine","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Cyclophosphamide","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Methotrexate","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Cyclosporine","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Tacrolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Sirolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Everolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Prednisone","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Mycophenolate mofetil","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Azathioprine","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Cyclophosphamide","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Methotrexate","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Cyclosporine","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Tacrolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Sirolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Everolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Prednisone","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Mycophenolate mofetil","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Theophylline","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Warfarin","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Phenytoin","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Methotrexate","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Cyclophosphamide","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Cyclosporine","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Tacrolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Sirolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Everolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Prednisone","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Mycophenolate mofetil","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Azathioprine","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Cyclophosphamide","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Methotrexate","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Cyclosporine","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Tacrolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Sirolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Everolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Prednisone","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Mycophenolate mofetil","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Azathioprine","action":"Monitor","effect":"Increased 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infections"},{"drug":"Cyclosporine","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Tacrolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Sirolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Everolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Prednisone","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Mycophenolate mofetil","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Azathioprine","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Cyclophosphamide","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Methotrexate","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Cyclosporine","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Tacrolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Sirolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Everolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Prednisone","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Mycophenolate mofetil","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Azathioprine","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Cyclophosphamide","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Methotrexate","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Cyclosporine","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Tacrolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Sirolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Everolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Prednisone","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Mycophenolate mofetil","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Azathioprine","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Cyclophosphamide","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Methotrexate","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Cyclosporine","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Tacrolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Sirolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Everolimus","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Prednisone","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Mycophenolate mofetil","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Azathioprine","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Cyclophosphamide","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Methotrexate","action":"Monitor","effect":"Increased risk of infections"}],"commonSideEffects":[{"effect":"Herpes zoster","drugRate":"1.6%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":61,"totalAffected":1,"trialsReporting":1},{"effect":"Rash","drugRate":"1.6%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":61,"totalAffected":1,"trialsReporting":1}],"contraindications":["Heart failure (NYHA class III/IV)","Previous hypersensitivity reaction to infliximab","Current severe infection (sepsis, tuberculosis)","Active infection","Malignancy","Preexisting demyelinating disease","Mild to moderate heart failure (NYHA class I/II)","History of seizures","Patients older than 65","Uncontrolled diabetes mellitus","Moderate to severe COPD","Live vaccines such as cholera vaccine, live virus MMR vaccine, smallpox vaccine (live vaccinia virus)"],"specialPopulations":{"Pregnancy":"The study evaluated pregnancy outcomes and infant developmental milestones for women with inflammatory bowel disease (IBD) who received reference infliximab and those who received a biosimilar. The authors said it is important to understand how to manage IBD during pregnancy because the peak reproductive years are also the peak years for diagnosis of IBD, which includes Crohn disease (CD) and ulcerative colitis (UC).","Geriatric use":"text","Paediatric use":"text","Renal impairment":"text","Hepatic impairment":"text"},"seriousAdverseEvents":[{"event":"Altered state of consciousness","detail":"MedDRA: Nervous system disorders. 1 trial(s).","severity":"serious","incidence":"1.6%"}]},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T21:04:04.060145+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T21:04:16.950574+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201581/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T21:03:56.924245+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (1 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T21:04:18.257327+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T21:03:55.739813+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T21:04:18.257317+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (1 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T21:04:18.257314+00:00"},"commercial.annualRevenue":{"url":"","method":"deterministic","source":"SEC EDGAR 10-K","rawText":"$646M FY2025","confidence":0.8,"sourceType":"sec_edgar","retrievedAt":"2026-04-19T21:04:04.060180+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (1 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:54:54.967926+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (1 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:54:54.967942+00:00"}},"allNames":"infliximab [infliximab biosimilar 3]","offLabel":[],"timeline":[],"aiSummary":"Pfizer's Infliximab [infliximab biosimilar 3] holds a significant market position with $646M in revenue and 11 approved indications, making it a strong player in the TNF-alpha inhibitor class. Its competitive advantage lies in its broad indication spectrum and established efficacy, though it faces robust competition from other TNF inhibitors like Etanercept and Adalimumab, which have similar or additional indications. A key risk is the lack of clinical trial data, which may limit its adoption and challenge its positioning against biosimilars like Erelzi and Cyltezo, which are backed by their reference products' extensive clinical histories. The pipeline outlook remains uncertain due to the absence of new clinical trials and the requirement for a PD-L1 companion diagnostic for several indications, potentially slowing its expansion into new therapeutic areas.","brandName":"Infliximab [infliximab biosimilar 3]","ecosystem":[],"isGeneric":true,"mechanism":{"target":"tumor necrosis factor-alpha (TNF-alpha)","novelty":"best-in-class","modality":"monoclonal antibody","drugClass":"monoclonal antibody","explanation":"Infliximab biosimilar 3 is a type of monoclonal antibody, which is a class of drugs that are designed to target specific proteins in the body. In this case, the drug targets tumor necrosis factor-alpha (TNF-alpha), a protein that plays a key role in inflammation. By binding to TNF-alpha, infliximab biosimilar 3 helps to reduce inflammation and prevent the progression of various inflammatory conditions. This mechanism of action is similar to other TNF-alpha inhibitors, but infliximab biosimilar 3 has shown clinical differentiation in its ability to provide sustained remission in patients with these conditions.","oneSentence":"Infliximab biosimilar 3 is a monoclonal antibody that targets tumor necrosis factor-alpha (TNF-alpha) to treat inflammatory conditions.","technicalDetail":"Infliximab biosimilar 3 is a chimeric monoclonal antibody that targets the p55 and p75 subunits of TNF-alpha. It works by binding to TNF-alpha and preventing it from interacting with its receptors, which helps to reduce inflammation and prevent tissue damage. The drug is administered via intravenous infusion and has a half-life of approximately 8-10 days."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"chemblData":{"prodrug":0,"chemblId":"CHEMBL1201581","maxPhase":"4.0","chirality":1,"parenteral":true,"availability":1,"moleculeType":"Antibody","withdrawnFlag":false,"naturalProduct":0,"blackBoxWarning":1,"oralBioavailable":false},"commercial":{"yoyGrowth":"7%","revenueYear":2025,"annualCostUS":"$80,000/yr","annualRevenue":646,"genericStatus":"Biologic — patent protected","revenueSource":"SEC 8-K Pfizer (2026-02-03)","currentRevenue":"$21.2B","revenueCurrency":"USD","peakSalesEstimate":"$21.2B","revenueConfidence":"verified (SEC filing)","revenueExtractedAt":"2026-04-01T11:46:10.597440","revenueExtractedBy":"revenue-sec"},"fdaRecalls":[],"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=infliximab-infliximab-biosimilar-3","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=infliximab-infliximab-biosimilar-3","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":4,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":5,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T07:54:56.735481+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Etanercept","company":"Amgen","advantage":"Etanercept (Enbrel) is indicated in the United States for RA, polyarticular juvenile idiopathic arthritis (JIA), PsA, AS, and PsO."},{"name":"Erelzi","company":"Sandoz","advantage":"Erelzi (etanercept-szzs) is a biosimilar referencing etanercept (Enbrel) and is subject to ongoing litigation."},{"name":"Eticovo","company":"Samsung Bioepis","advantage":"Eticovo (etanercept-ykro) is a biosimilar referencing etanercept (Enbrel) and has not been launched."},{"name":"Adalimumab","company":"AbbVie","advantage":"Adalimumab (Humira) is indicated in the United States for RA, JIA, PsA, AS, CD (adult and pediatric), PsO, hidradenitis suppurativa, and noninfectious uveitis (adult and pediatric patients ≥ 2 years)."},{"name":"Cyltezo","company":"Biosimilars/Viatris","advantage":"Cyltezo (adalimumab-adbm) is a biosimilar referencing adalimumab (Humira) and will be launched in the United States in 2023."},{"name":"Hulio","company":"Mylan","advantage":"Hulio (adalimumab-bwwd) is a biosimilar referencing adalimumab (Humira) and will be launched in the United States in 2023."},{"name":"Adalimumab-aqvh","company":"Coherus BioSciences","advantage":"Yusimry (adalimumab-aqvh) is a biosimilar referencing adalimumab (Humira) and will be launched in the United States in 2023."},{"name":"Renflexis","company":"Organon","advantage":"Renflexis (infliximab-abda) is a biosimilar referencing infliximab (Remicade) and has been marketed."},{"name":"Avsola","company":"Amgen","advantage":"Avsola (infliximab-axxq) is a biosimilar referencing infliximab (Remicade) and has been marketed."},{"name":"Ixifi","company":"Pfizer","advantage":"Ixifi (infliximab-qbtx) is a biosimilar referencing infliximab (Remicade) but will not be launched in the United States."},{"name":"Infliximab","company":"Janssen Biotech","advantage":"Infliximab (Remicade) is indicated in the United States for the treatment of RA, CD (adult and pediatric), UC (adult and pediatric), AS, PsA, and PsO."},{"name":"Infliximab-dyyb","company":"Pfizer","advantage":"Inflectra (infliximab-dyyb) is a biosimilar referencing infliximab (Remicade) and has been marketed."}],"genericName":"infliximab-infliximab-biosimilar-3","indications":{"approved":[{"name":"Moderate to severe Crohn's disease","regulator":"FDA"},{"name":"Mild to moderate ulcerative colitis","regulator":"FDA"},{"name":"Ankylosing spondylitis","regulator":"FDA"},{"name":"Psoriatic arthritis","regulator":"FDA"},{"name":"Rheumatoid arthritis","regulator":"FDA"},{"name":"Plaque psoriasis","regulator":"FDA"},{"name":"Crohn's disease","regulator":"FDA"},{"name":"Ulcerative colitis","regulator":"FDA"},{"name":"Psoriasis","regulator":"FDA"},{"name":"Juvenile idiopathic arthritis","regulator":"FDA"},{"name":"Uveitis","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03885037","phase":"","title":"Infliximab Biosimilar for Intravenous Drip Infusion 100 mg \"Pfizer\" Drug Use Investigation (Rheumatoid Arthritis)","status":"","acronym":null,"sponsor":"Pfizer","isPivotal":false,"primaryCI":"","primaryHR":"","enrollment":77,"indication":"Rheumatoid Arthritis","endpointCount":3,"primaryPValue":"","completionDate":"","primaryEndpoint":"Number of Participants With Adverse Drug Reactions (ADRs)"}],"_emaApprovals":[{"date":"","name":"Infliximab [infliximab biosimilar 3]","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"molecularData":{"oral":false,"chemblId":"CHEMBL1201581","moleculeType":"Antibody","molecularWeight":""},"_patentsChecked":true,"_warningLetters":[{"date":"03/28/2023","subject":"11/07/2022\tTodos Medical Ltd aka Todos Medical USA Inc\tCenter for Food Safety and Applied Nutrition"},{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"chemblId":"CHEMBL1201581"},"formularyStatus":[],"_offLabelChecked":true,"chemblMechanisms":[{"actionType":"INHIBITOR","targetChemblId":"CHEMBL1825","mechanismComment":null,"mechanismOfAction":"TNF-alpha inhibitor"}],"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Oncology"],"_revenueScrapedAt":"2026-04-01 10:46:09.909486+00","biosimilarFilings":[],"recentPublications":[],"_drugWebsiteChecked":true,"participantFlowData":[{"nctId":"NCT03885037","groups":[{"id":"FG000","title":"Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]","description":"Participants with rheumatoid arthritis (RA) who received Infliximab BS for I.V. Infusion 100mg \\[Pfizer\\] \\[Infliximab Biosimilar 3\\] as indicated in the approved local product document for the first "}],"acronym":null,"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"77"}},{"type":"COMPLETED","counts":{"FG000":"61"}},{"type":"NOT COMPLETED","counts":{"FG000":"16"}}],"dropWithdraws":[{"type":"Protocol Violation","counts":{"FG000":"16"}}]}],"recruitment":"","preAssignment":""}],"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"structuredTrialResults":[{"nctId":"NCT03885037","phase":"","title":"Infliximab Biosimilar for Intravenous Drip Infusion 100 mg \"Pfizer\" Drug Use Investigation (Rheumatoid Arthritis)","acronym":null,"sponsor":"Pfizer","isPivotal":false,"conditions":["Rheumatoid Arthritis"],"enrollment":77,"otherEndpoints":[],"primaryEndpoints":[{"type":"PRIMARY","title":"Number of Participants With Adverse Drug Reactions (ADRs)","results":[{"value":"1","spread":"","groupId":"OG000","groupTitle":"Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"COUNT_OF_PARTICIPANTS","timeFrame":"30 weeks from the day of initial dose","description":"An ADR was a treatment-related adverse event, and any untoward medical occurrence attributed to Infliximab BS for I.V. Infusion 100mg \\[Pfizer\\] \\[Infliximab Biosimilar 3\\] in a participant who received this drug. A serious ADR was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; and congenital anomaly/birth defect. Relatedness to Infliximab BS for I.V. Infusion 100mg \\[Pfizer\\] \\[Infliximab Biosimilar 3\\] was assessed.","unitOfMeasure":"Participants","reportingStatus":"POSTED"}],"secondaryEndpoints":[{"type":"SECONDARY","title":"Change in Disease Activity Score Based on 28-joint Count and C-reactive Protein (4 Variables) (DAS28 [4/CRP])","results":[{"value":"-0.175","spread":"0.689","groupId":"OG000","groupTitle":"Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"30 weeks from the day of initial dose","description":"The Disease Activity Score based on 28-joint count and C-reactive protein (DAS28 \\[4/CRP\\]) was calculated using four variables: Tender Joint Count (TJC28) and Swollen Joint Count (SJC28), both scored from 0 to 28; participant's overall activity assessed by the Visual Analog Scale (VAS, 0-100 mm); and C-reactive protein (CRP, ≥0 mg/dL). Higher scores indicate increased disease activity.\n\nThe formula is:\n\nDAS28 (4/CRP) = 0.56 × √(TJC28) + 0.28 × √(SJC28) + 0.36 × LN((CRP) × 10 + 1) + 0.014 × (VAS) + 0.96.\n\nChanges in DAS28 (4/CRP) from baseline to study completion were summarized as mean ± standard deviation, overall, as well as separately based on prior infliximab use before the initial dose of this drug. Greater negative changes reflect larger reductions in disease activity.","unitOfMeasure":"Scores of DAS28 (4/CRP)","reportingStatus":"POSTED"},{"type":"SECONDARY","title":"Percentage of Participants With Remission (DAS28 [4/CRP])","results":[{"value":"76.9","spread":"","groupId":"OG000","groupTitle":"Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]","lowerLimit":"46.19","upperLimit":"94.96"}],"analyses":[],"paramType":"NUMBER","timeFrame":"30 weeks from the day of initial dose","description":"Percentage of participants with a remission based on DAS28 (4/CRP) was presented along with the two-sided 95% confidence interval (exact method).\n\nFor participants with available DAS28 (4/CRP) values both at baseline and study completion, the number and proportion of those who achieved remission (\\<2.3) at both time points were calculated overall, as well as separately based on prior infliximab use before the initial dose of this drug.","unitOfMeasure":"Percentage of Participants","reportingStatus":"POSTED"}]}],"genericManufacturerList":[],"phase":"marketed","status":"active","companyName":"Pfizer","companyId":"pfizer","modality":"Monoclonal antibody","firstApprovalDate":"","enrichmentLevel":5,"visitCount":12,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"pricingByCountry":[{"country_code":"US","currency":"USD","price_amount":"80000.00","price_per":"year","price_type":"annual_list","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":3,"withResults":3},"validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T07:54:56.735481+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}