Mundipharma’s Neulasta biosimilar approved in EU

A second cut-price biosimilar of Amgen’s Neulasta (pegfilgrastim) long-acting white blood cell booster is to hit the EU market after the European Commission approved Mundipharma’s Pelmeg. Pelmeg can now be used in Europe for patients with neutropenia and febrile neutropenia in adult cancer patients treated with chemotherapy. Pelmeg was developed by Spain’s Cinfa Biotech, which Mundipharma acquired last month, after regulators on the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) scientific committee gave the drug the green light.
A marketing authorization from the European Commission is almost a formality within a few months of a positive opinion from the CHMP. Pelmeg follows hot on the heels of the first Neulasta biosimilar approved in the EU, Coherus BioSciences’ Udenyca, which was rubber-stamped in July. There are already several biosimilars of Amgen’s short-acting white blood cell booster, Neupogen (filgrastim) on the European market, such as Sandoz’s Zarzio. Philippe Bastide, head of biosimilars at Mundipharma International, said: “We hope this approval will significantly improve the lives of people who are affected by chemotherapy-induced neutropenia and febrile neutropenia. The availability of this biosimilar represents an important opportunity to reduce healthcare costs while increasing access to an effective treatment option.”