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.
Biocon Chief Executive Officer & Joint Managing Director Arun Chandavarkar said, "CHMP's decision to recommend approval of Biocon and Mylan's biosimilar Pegfilgrastim brings us a step closer to offer this high quality, affordable biologic therapy for cancer patients in the EU, having launched this product in the US, earlier this year.”
Pegfilgrastim is used to treat low count of neutrophils in patients undergoing chemotherapy in certain types of cancer. Fulphila was approved by the US Food and Drug Administration in June for sales in the US market. It is one of 11 biologic and insulin products co-developed by Mylan and Biocon for the global marketplace.