CHMP recommends Nyvepria pegfilgrastim biosimilar.- Pfizer.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nyvepria, intended to reduce the duration of neutropenia and to help prevent febrile neutropenia after cytotoxic chemotherapy. The applicant for this medicinal product is Pfizer Europe .Nyvepria will be available as a 6-mg solution for injection. The active substance of Nyvepria is pegfilgrastim, an immunostimulant and colony stimulating factor (ATC code: L03AA13), which stimulates the production and release of neutrophils from the bone marrow. Nyvepria 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 Nyvepria has comparable quality, safety and efficacy to Neulasta (pegfilgrastim).