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Biocon, Mylan’s joint product Fulphila gets approval in EU

Biocon and Mylan’s jointly developed Fulphila, a biosimilar Pegfilgrastim, has been approved in EU. The European Commission has granted Marketing Authorization for Fulphila to the company’s 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.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient’s worldwide.