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 TevaGrastimÂ®.
G-CSF, mainly indicated for the treatment of chemotherapy-induced neutropenia, was developed by Teva in collaboration with a partner. The innovator product, NeupogenÂ® 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.
â€œCoupled 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.