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Published on 25 February 2008

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EMEA gives positive opinion to Teva biosimilar

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CHMP, the scientific committee of the European Medicines Agency (EMEA), has given a positive opinion regarding a biosimilar human granulocyte colony stimulating factor (G-CSF) product.

The European Commission is now expected to grant marketing authorisation for this product, which will be marketed in the EU by Israel-based manufacturers Teva Pharmaceuticals under the brand name TevaGrastim®.

G-CSF, mainly indicated for the treatment of chemotherapy-induced neutropenia, was developed by Teva in collaboration with a partner. The innovator product, Neupogen® Filgrastim, had annual sales of approximately $300 million in the EU for the twelve months ended September 30, 2007, based on IMS sales data.

Amir Elstein, Executive Vice President, Global Resources of Teva, said: “We are very pleased to receive the first positive opinion for a biosimilar G-CSF product in the EU and believe that it shows the strength of our biotechnology R&D capabilities.

“Coupled with our recent acquisition of CoGenesys, which significantly enhances our capabilities, our strong biogeneric pipeline reflects our determination to capture the considerable long-term prospects we believe the biogeneric market will offer.”

Teva currently markets a portfolio of biopharmaceutical products including human growth hormone (hGH) in the United States, as well as interferon alpha 2b, G-CSF and hGH outside the United States. Teva’s biogeneric pipeline includes many other products to be commercialised in the US and the EU, as well as in other markets.

Teva Pharmaceuticals



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