Noticia de Contratación

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.