Three firms in EU get nods on pegfilgrastim
Three firms – Mundipharma, Mylan and Sandoz – have received final pan-European marketing authorisations from the European Commission for biosimilar rivals toAmgen’s Neulasta (pegfilgrastim). The nods for Mundipharma’s Pelmeg, Mylan’s Fulphila and Sandoz’ Ziextenzo followed positive recommendations from the European Medicines Agency’s (EMA’s) committee for human medicinal products (CHMP) towards the end of September (Generics bulletin, 28 September 2018, page 15).
You may also be interested in...
Mundipharma is entering into a partnership with Egis for launching its pegfilgrastim biosimilar treatment in Hungary, Romania, Latvia and Lithuania.
Juta Pharma has received a positive opinion from the European Medicines Agency’s CHMP recommending granting a pan-European marketing authorization for its biosimilar pegfilgrastim, Grasustek.
Sandoz has resubmitted its application for biosimilar pegfilgrastim to the FDA, having been knocked back with a complete response letter in 2016.