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Hospira's filgrastim biosimilar given CHMP nod

 
• By Katie McQue

The EU's CHMP has adopted a positive opinion on Hospira's Nivestim (filgrastim; 12MU/0.2ml, 30MU/0.5mg, 48MU/0.5ml) solution for injection or infusion for the treatment of neutropenia. Nivestim is a biosimilar of Amgen's Neupogen which was the reference product for the application.

The EU's CHMP has adopted a positive opinion on Hospira's Nivestim (filgrastim; 12MU/0.2ml, 30MU/0.5mg, 48MU/0.5ml) solution for injection or infusion for the treatment of neutropenia. Nivestim is a biosimilar of Amgen's Neupogen which was the reference product for the application.

There are already filgrastim biosimilars marketed in various European countries; these include products from Sandoz (Novartis), Teva and Ratiopharm, each of which referenced Neupogen (scripnews.com, 21 July 2009).

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