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.”