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).
EMA approves follitropin alfa biosimilar
Biosimilars/News | Posted 14/02/2014 0 Post your comment
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.
Related article
Biosimilars applications under review by EMA – 2013 Q4
Reference
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
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2014 Pro Pharma Communications International. All Rights Reserved.
Source: EMA
Research
Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
Comments (0)
Post your comment