Bemfola is a follicle stimulating hormone (FSH) used for the treatment of infertility. The drug is a biosimilar of Merck’s blockbuster in vitro fertilization drug Gonal-F.

Bemfola has been approved by TGA for the treatment of infertility in adult women and adult men. In women indications include controlled ovarian hyper-stimulation and stimulation of follicular development. While in men Bemfola is indicated with the concomitant human chorionic gonadotropin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective.

Finox received approval for Bemfola from the European Medicines Agency in March 2014 [1]. The company is also carrying out a pivotal phase III study (FIN3002) for registration of Bemfola (Afolia) in the US.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 5]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe  

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