{"id":"ct-p55","safety":{"commonSideEffects":[{"rate":null,"effect":"Cardiotoxicity / left ventricular dysfunction"},{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Nausea and vomiting"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Diarrhea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"CT-P55 is a monoclonal antibody designed as a biosimilar to trastuzumab (Herceptin). It binds to the human epidermal growth factor receptor 2 (HER2) on cancer cells, preventing HER2 signaling and triggering antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). This mechanism inhibits proliferation of HER2-overexpressing tumors.","oneSentence":"CT-P55 is a biosimilar of trastuzumab that targets HER2-positive cancer cells by binding to the HER2 receptor and blocking growth signaling.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:08:02.222Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HER2-positive metastatic breast cancer"},{"name":"HER2-positive early-stage breast cancer (adjuvant/neoadjuvant setting)"}]},"trialDetails":[{"nctId":"NCT06630559","phase":"PHASE3","title":"A Study to Compare Efficacy and Safety of CT-P55 and Cosentyx in Patients With Moderate to Severe Psoriasis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Celltrion","startDate":"2025-05-26","conditions":"Plaque Psoriasis","enrollment":153},{"nctId":"NCT07054970","phase":"PHASE1","title":"To Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55 and Cosentyx in Healthy Subjects","status":"COMPLETED","sponsor":"Celltrion","startDate":"2024-01-12","conditions":"Healthy Male Subjects","enrollment":172}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"CT-P55","genericName":"CT-P55","companyName":"Celltrion","companyId":"celltrion","modality":"Biologic","firstApprovalDate":"","aiSummary":"CT-P55 is a biosimilar of trastuzumab that targets HER2-positive cancer cells by binding to the HER2 receptor and blocking growth signaling. Used for HER2-positive metastatic breast cancer, HER2-positive early-stage breast cancer (adjuvant/neoadjuvant setting).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}