Napp Pharmaceuticals has announced the UK launch of Pelmeg, a biosimilar pegfilgrastim developed by Cinfa Biotech and subsequently acquired by Mundipharma.
The biosimilar, which is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in adults undergoing cytotoxic chemotherapy, and which is self-administered, is Napp’s first launch of a product developed by Cinfa.
Paul Clark, director of biosimilars at Napp Pharmaceuticals, said in a statement announcing the launch, “We are proud to be delivering treatments that address patient need in the oncology treatment pathway and that could potentially improve patient experience at such a critical time. We hope that Pelmeg will not only help to alleviate some of the resource pressures on the [National Health Service] by providing a more affordable long-acting treatment option, but that it may also help improve patient access to these vital medicines.”
Pelmeg was authorized by the European Commission in November 2018 following 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 (PD) and immunogenicity that was presented at the American Society of Hematology’s annual meeting in December 2017.
The UK launch of Pelmeg follows a February launch of the biosimilar in Germany, the Netherlands, and Irleand, by Mundipharma, a network of companies that operates in 120 countries worldwide, and that is also engaged in an ongoing partnership with Republic of Korea-based drug maker Celltrion. Mundipharma is responsible for commercializing Celltrion’s Remsima (biosimilar infliximab), Truxima (biosimilar rituximab), and Herzuma (biosimilar trastuzumab) across Europe.
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