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Teva Pharmaceutical Industries Ltd.

Teva's Developed G-CSF is the First Biosimilar to Receive a Positive Opinion from European Union Regulators

Published in Medical Letter on the CDC and FDA, March 9th, 2008

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced the receipt of a positive opinion from the CHMP, the scientific committee of the European Medicines Agency ("EMEA"), for its human granulocyte colony stimulating factor ("G-CSF") product. Teva's product is the first biosimilar G-CSF to receive a positive opinion in the European Union.

The European Commission is now expected to grant marketing authorization for this product, which will be marketed in the EU by Teva under the brand name TevaGrastim(R).

G-CSF, mainly indicated for the treatment of chemotherapy-induced neutropenia, was developed by Teva in collaboration with a partner. The...

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