Australian approval for infertility biosimilar Bemfola

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Australian approval for infertility biosimilar Bemfola

Biosimilars/News | Posted 05/02/2016 0 Post your comment

Switzerland-based Finox Biotech (Finox) announced on 30 November 2015 that it had gained approval from Australia’s drug regulator, the Therapeutic Goods Administration (TGA), for follitropin alfa biosimilar Bemfola.

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.

Related article
Biosimilars approved in Australia

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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Source: Finox, TGA