{"id":"myl-1401h","safety":{"commonSideEffects":[{"rate":null,"effect":"Cardiotoxicity / left ventricular dysfunction"},{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Nausea and vomiting"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As a trastuzumab biosimilar, MYL-1401H is a monoclonal antibody that targets human epidermal growth factor receptor 2 (HER2) expressed on cancer cells. By binding to HER2, it blocks growth signaling and recruits immune cells to destroy HER2-positive tumor cells through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).","oneSentence":"MYL-1401H is a biosimilar of trastuzumab that binds to HER2 receptors on cancer cells to inhibit their growth and promote immune-mediated cell death.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:22:27.162Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HER2-positive metastatic breast cancer"},{"name":"HER2-positive early-stage breast cancer (adjuvant/neoadjuvant setting)"},{"name":"HER2-positive metastatic gastric cancer"}]},"trialDetails":[{"nctId":"NCT02479646","phase":"PHASE1","title":"Pharmacokinetic / Pharmacodynamic Study Comparing MYL-1401H, EU-sourced Neulasta and US-licensed Neulasta","status":"COMPLETED","sponsor":"Mylan Inc.","startDate":"2014-09","conditions":"Healthy Volunteers","enrollment":218},{"nctId":"NCT02467868","phase":"PHASE3","title":"Efficacy and Safety Study With MYL-1401H and Neulasta","status":"COMPLETED","sponsor":"Mylan Inc.","startDate":"2015-03","conditions":"Breast Neoplasms, Chemotherapy-Induced Febrile Neutropenia","enrollment":193}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Recombinant human granulocyte colony-stimulating factor (G-CSF)","Pegfilgrastim"],"phase":"phase_3","status":"active","brandName":"MYL-1401H","genericName":"MYL-1401H","companyName":"Mylan Inc.","companyId":"mylan-inc","modality":"Biologic","firstApprovalDate":"","aiSummary":"MYL-1401H is a biosimilar of trastuzumab that binds to HER2 receptors on cancer cells to inhibit their growth and promote immune-mediated cell death. Used for HER2-positive metastatic breast cancer, HER2-positive early-stage breast cancer (adjuvant/neoadjuvant setting), HER2-positive metastatic gastric cancer.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}