Biosimilar Pegfilgrastim Co-Developed by Biocon Receives Approval in EU

Published On: November 30th 2018 at 5:09 PM

biocon limitedFulphila, a biosimilar Pegfilgrastim jointly developed by Biocon and Mylan, has been approved in EU. The European Commission has granted Marketing Authorization for Fulphila to our partner Mylan.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (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.

Biosimilar Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy.” – Company Spokesperson,