Posted by Michael Wonder on 03 Dec 2018
Biosimilar pegfilgrastim co-developed by Biocon receives approval in EU
30 November 2018 - Fulphila, a biosimilar pegfilgrastim jointly developed by Biocon and Mylan, has been approved in EU.
The European Commission has granted marketing authorisation for Fulphila to our partner Mylan.
The European Medicines Agency’s CHMP had issued a positive opinion recommending approval of Fulphila as a biosimilar to Amgen’s Neulasta, which is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy, in September 2018.
