Biocon and Mylan's cancer biosimilar gets CHMP nod for approval in EU

The CHMP opinion for the drug to be sold under the named Fulphila will now be considered by the European Commission and the decision on approval is expected by November

Biopharma major Biocon on Friday announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of its biosimilar pegfilgrastim, co-developed by Mylan. 

The CHMP opinion for the drug to be sold under the named Fulphila, a biosimilar to Amgen’s Neulasta, will now be considered by the European Commission and the decision on approval is expected by November. Neulasta had brand sales of over $450 million in Europe for the year ended June 30.