Mundipharma’s Pegfilgrastim Mundipharma (biosimilar, pegfilgrastim) Receives CHMP Positive Opinion for MAA in EU

Egis Pharmaceuticals Signs an Exclusive Distribution Agreement with Mundipharma for Pelmeg (pegfilgrastim, biosimilar) in Central and Eastern Europe


  • The Mundipharma biosimilar Pegfilgrastim Mundipharma (6mg solution injection) will be authorized for sales in the EU to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy
  • In Nov’2018, Mundipharma has received EC’s approval with trade name Pelmeg having same indication & same dose, which also get CHMP’s positive opinion based on the comparability study of pharmacodynamics and immunogenicity with Neulasta
  • The commercialization of Pelmeg in the EU raises the question that Pegfilgrastim Mundipharma fits in the company’s business strategy. Mundipharma did not respond to clarify whether Pegfilgrastim Mundipharma is a separately developed product or a duplicate of Pelmeg

Click here to­ read full press release/ article | Ref: Centers for Biosimilar | Image: The Times