Fulphila, a biosimilar Pegfilgrastim, jointly developed by Biocon and Mylan, has been approved in European Union (EU), Biocon said in a regulatory filing.
In September, European Medicines Agency's Committee for Medicinal Products for Human Use had issued a positive opinion recommending approval of the product which is biosimilar to Amgen's Neulasta.
Biosimilar Pegfilgrastim treatment can be used to stimulate the bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy, the company said.
According to IQVIA, Neulasta had sales of more than USD 450 million (Rs 3136 crore) in Europe for the 12 months ending June 30, 2018.
Biocon shares Friday ended 3.27 per cent up at Rs 622.25 apiece on the BSE.
(With inputs from agencies.)