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Published on 21 November 2008

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Sandoz receives positive EU opinion for biosimilar filgrastim

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Sandoz has received a positive opinion from European regulators for its third biosimilar medicine, filgrastim, marking another important milestone in its efforts to bring affordable high-quality biopharmaceuticals to patients worldwide.

Filgrastim is indicated for use in treating neutropenia, a condition characterized by lack of neutrophils – one of the most common types of white blood cells – that is often associated with chemotherapy or bone marrow transplants. Filgrastim is a natural man-made protein produced commercially by recombinant DNA technology, which stimulates production of white blood cells.

Sandoz CEO Andreas Rummelt says: “The positive opinion from the CHMP (Committee on Medicinal Products for Human Use) is an important first step towards receiving EU regulatory approval. Such approval would provide an important new option, in particular for patients undergoing chemotherapy.

“Filgrastim enables them to stay on their required course of therapy at the optimal dose level by raising neutrophil counts to within the normal range. In addition to significant potential cost savings, our product offers patients and healthcare providers a very pure form of filgrastim.”

This is the third time that the CHMP, which reviews medicines scientifically in the EU, has issued a positive opinion for a Sandoz biosimilar. In a precedent-setting decision in April 2006, Sandoz was the first company to obtain EU approval for such a medicine, human growth hormone Omnitrope. Binocrit / Epoetin alfa Hexal, the first follow-on erythropoetin and the first complex (glycoprotein) biosimilar, was approved in the EU in August 2007 and launched the same year. Sandoz, the biosimilars pioneer,  also has a comprehensive pipeline, with two dozen projects at various stages of development.

Novartis



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