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EMEA grants positive opinion to Teva’s biosimilar G-CSF product

Teva Pharmaceutical Industries has received positive opinion from the CHMP, the scientific committee of the European Medicines Agency or EMEA, for its human granulocyte colony stimulating factor G-CSF product.

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. G-CSF is mainly indicated for the treatment of chemotherapy-induced neutropenia.

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.”