CHMP clears an another filgrastim biosimilar

July 31, 2013 10:42 AM

Last week, European watchdog, EMA approved one more filgrastim biosimilar. 

The positive opinion is issued by the EMA’s CHMP, Committee for Medicinal Products for Human Use. The new filgrastim biosimilar is Grastofil, 30 MU/0.5 ml and 48 MU/0.5 ml, solution for injection or infusion intended for intended for the treatment of neutropenia.

The applicant for this medicinal product is Apotex Europe B.V. Grastofil is a biological medicinal product similar to the reference product Neupogen authorised in the EU. Studies have shown Grastofil to have a comparable quality, safety and efficacy profile to Neupogen (filgrastim).

Currently there are several filgrastim biosimilars like Biograstim, Filgrastim Hexal, Tevagrastim, Ratiograstim, Nivestim in the European Union and Grastofil is the latest biosimilar which will come to the market after the approval of European Commission.

 

Source: EMA

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