EMA approves follitropin alfa biosimilar

Biosimilares/Novedades | Posted 14/02/2014 post-comment0 Post your comment

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 23 January 2014 that it had recommended the granting of a marketing authorization for biosimilar infertility treatment Bemfola (follitropin alfa).

Follitropin V13I20

Bemfola is a follicle-stimulating hormone (FSH) used for the treatment of infertility. The drug, which is produced by Switzerland-based Finox Biotech, is a biosimilar of Merck’s blockbuster in vitro fertilization drug Gonal-F. Bemfola is the second biosimilar version of follitropin alfa available on the European market [1].

Finox Biotech conducted clinical trials involving nearly 400 patients in phase I or III studies. Data from a phase III found Bemfola to be similar to Gonal-F, based on the numbers of oocytes (female gametocyte or germ cell involved in reproduction) retrieved after completing FSH therapy. Similar efficacy and safety profiles were also observed between the two study arms and similar numbers of live babies were born to patients who became pregnant following completion of therapy.

The CHMP’s recommendation will now be reviewed by the European Commission, which grants approval of medicines for the European Union (EU). Once approved, Finox Biotech expects Bemfola to be available in the EU in the second quarter of 2014.

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1.  GaBI Online - Generics and Biosimilars Initiative. EMA approves biosimilar follitropin alfa and somatropin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 14]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-biosimilar-follitropin-alfa-and-somatropin

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Source: EMA

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