{"id":"biosimilar-recombinant-fsh","safety":{"commonSideEffects":[{"rate":null,"effect":"Ovarian hyperstimulation syndrome (OHSS)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Abdominal pain/discomfort"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This biosimilar replicates the action of endogenous follicle-stimulating hormone (FSH), a gonadotropin that promotes follicular development in the ovary. By activating FSH receptors on ovarian granulosa cells, it increases estrogen production and facilitates the recruitment and maturation of multiple follicles, essential for assisted reproductive technologies. The biosimilar formulation is bioequivalent to the reference recombinant FSH product.","oneSentence":"Biosimilar recombinant FSH stimulates the growth and maturation of ovarian follicles by binding to and activating follicle-stimulating hormone receptors on granulosa cells.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:28:36.916Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Infertility in women undergoing assisted reproductive technology (ART) / in vitro fertilization (IVF)"},{"name":"Anovulation and ovulatory disorders in women"}]},"trialDetails":[{"nctId":"NCT04854707","phase":"","title":"An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data","status":"COMPLETED","sponsor":"IVFarma LLC","startDate":"2020-01-12","conditions":"Reproductive Issues, Reproductive Disorder, Fertility Disorders","enrollment":5484},{"nctId":"NCT02503605","phase":"PHASE4","title":"Biosimilar Versus Urinary Gonadotropins","status":"UNKNOWN","sponsor":"IVI Madrid","startDate":"2015-10","conditions":"Infertility","enrollment":130}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":10,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Bemfola"],"phase":"marketed","status":"active","brandName":"Biosimilar recombinant FSH","genericName":"Biosimilar recombinant FSH","companyName":"IVI Madrid","companyId":"ivi-madrid","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Biosimilar recombinant FSH stimulates the growth and maturation of ovarian follicles by binding to and activating follicle-stimulating hormone receptors on granulosa cells. Used for Infertility in women undergoing assisted reproductive technology (ART) / in vitro fertilization (IVF), Anovulation and ovulatory disorders in women.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}