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NOTICIA DE CONTRATACIÓN
Napp Pharmaceuticals has announced the UK launch of Pelmeg, a biosimilar pegfilgrastim developed by Cinfa Biotech and subsequently acquired by Mundipharma.
05 Marzo 2019 | Fuente original
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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