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1st Biosimilar Approval

Intas Pharmaceuticals Limited - Gets the 1st Biosimilar Approval for EU

European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended granting of a European marketing authorization to Intas Pharmaceuticals Limited's Subsidiary - Accord Healthcare's Filgrastim biosimilar. As per the CHMP, Accord's biosimilar Filgrastim - submitted under Accofil brand name - has demonstrated "comparable quality, safety and efficacy" with its reference product. Please find the link below:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003956/smops/Positive/human_smop_000719.jsp&mid=WC0b01ac058001d127