CHMP provides positive opinion for biosimilar Grasustek
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Grasustek, intended for prophylaxis against neutropenia in adult patients treated with cytotoxic chemotherapy. The applicant for this medicinal product is Juta Pharma GmbH.
Grasustek is a biosimilar medicinal product. It is highly similar to the reference product Neulasta (pegfilgrastim), which was authorised in the EU on 22 August 2002. Data show that Grasustek has comparable quality, safety and efficacy to Neulasta.
Comment: The patents on Neulasta expired in the US in October 2015 and expired in Europe in August 2017.
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