EMA approves biosimilar follitropin alfa and somatropin

Biosimilars/News | Posted 20/09/2013 post-comment0 Post your comment

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 31 July 2013 that it had recommended granting of marketing authorization for a biosimilar follitropin alfa. While on 9 September 2013, the agency announced the approval of a new somatropin biosimilar.

Follitropin V13I20

The follitropin alfa biosimilar (Ovaleap) is produced by generics giant Teva Pharmaceutical Industries. Ovaleap is a biosimilar of Merck’s in vitro fertilization drug Gonal-F, which contains recombinant follicle stimulating hormone (FSH), which helps egg development in the ovaries. There are currently no biosimilars of follitropin alfa available on the European market.

The somatropin biosimilar (Somatropin Biopartners) is manufactured by BioPartners, a Switzerland-based subsidiary of Polish biotech company Bioton. The drug is a biosimilar of Eli Lilly’s recombinant human growth hormone Humatrope, which is used for the treatment of growth failure in children.

Although there is already a somatropin biosimilar approved by EMA [1], Somatropin Biopartners is the first prolonged-release somatropin-containing medicinal product to receive a positive CHMP opinion.

The CHMP’s recommendation for Somatropin Biopartners will now be referred to the European Commission which grants approval for the European Union, Norway and Iceland. The Commision’s final approval is anticipated in the third quarter of 2013.

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1.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 20]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: EMA

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