Mylan gets EU approval for Fulphila
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Biotechnology major Biocon Friday said the European Commission has granted marketing authorisation to its partner Mylan for Fulphila, a biosimilar product to treat cancer.
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.
It 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.
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.)
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