EMEA greenlights biosmilar G-CSF
The very first biosimilar version of the human granulocyte colony stimulating factor (G-CSF), for the treatment of neutropenia, got the go-ahead from the European drug authority EMEA in February. The EMEA’s CHMP issued positive opinions on four biosimilar versions of filgrastim. The biosimilar versions are Ratiopharm’s Ratiograstim and Filgrastim Ratiopharm, CT Arzneimittel’s Biograstim, and Teva Generics’ Tevagrastim. In contrast to Sicor Biotech’s non-approved Grasalva (see EuroBiotechNews 1-2/2008), for which Lithuania has been sued by the European Commission, the four products had been shown to be similar to the reference product Neupogen (Amgen), the original reference drug, which achieved revenues of roughly $1.3 billion last year.