Australian approval for infertility biosimilar Bemfola

Biosimilars/News | Posted 05/02/2016 post-comment0 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.

Follitropin V13I20

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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Biosimilars approved in Australia 

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

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Source: Finox, TGA

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