European Commission Authorizes Pegfilgrastim Biosimilar, Pelmeg

The European Commission has granted a marketing authorization to Cinfa Biotech and Mundipharma’s biosimilar pegfilgrastim, Pelmeg, for all indications of the reference product, Neulasta.

The authorization of the drug indicated to reduce the duration and incidence of febrile neutropenia in adults treated with cytotoxic chemotherapy follows a positive recommendation from the Committee for Medicinal Products for Human Use in September 2018. The biosimilar gained a positive recommendation on the basis of a comprehensive package of data including a comparability study of pharmacodynamics and immunogenicity that was presented at the American Society of Hematology’s annual meeting in December 2017.

“We hope this approval will significantly improve the lives of people who are affected by chemotherapy induced neutropenia and febrile neutropenia," Phillippe Bastide, head of biosimilars at Mundipharma, said in a statement. "The availability of this biosimilar represents an important opportunity to reduce healthcare costs while increasing access to an effective treatment option.”

Pelmeg will be the fourth biosimilar commercialized in Europe by Mundipharma, a network of companies that operates in 120 countries worldwide, which acquired Cinfa Biotech October 2018; the company is engaged in an ongoing partnership with Korean drug maker Celltrion to commercialize Remsima (biosimilar infliximab), Truxima (biosimilar rituximab), and Herzuma (biosimilar trastuzumab) in Europe. In addition to access to the biosimilar pegfilgrastim, acquisition of Cinfa Biotech provides Mundipharma with additional research and development capacity for future biosimilar products.

When it enters the European market, Pelmeg will become the third biosimilar pegfilgrastim product available; 2018 saw a spate of approvals in the pegfilgrastim space, with Coherus Biosciences’ Udenyca and Accord Healthcare’s Pelgraz authorized in September (Udenyca also earned FDA approval in November). Another biosimilar pegfilgrastim, Mylan and Biocon’s Fulphila, is currently awaiting EU authorization (the product has been FDA approved and launched in the United States).

The biosimilar will also compete with a range of EU-approved short-acting granulocyte colony-stimulating factor biosimilars and follow-ons, including Zarzio/Filgrastim Hexal, Accofil, Grastofil, Nivestim, and Ratiograstim/Tevagrastim.