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Mundipharma's Neulasta biosimilar approved in EU

Published on 26/11/18 at 10:54am

Mundipharma has revealed that Pelmeg, its biosimilar version of Amgen’s Neulasta (pegfilgrastim), has been awarded marketing approval by the European Commission.

The decision was driven by a “a robust regulatory submission” of data which supported the biosimilarity of Pelmeg to its reference product, demonstrating non-inferiority in pharmacodynamics, pharmacokinetics, and immunogenicity. It also follows a positive recommendation to approve the product from the Committee for Medicinal Products for Human Use (CHMP). As a result, Pelmeg has been indicated in the exact same way as the subcutaneous form of its reference product, Neulasta.

As a result, Pelmeg will now be available for use to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy, with the exception of chronic myeloid leukaemia and myelodysplastic syndromes.

“We hope this approval will significantly improve the lives of people who are affected by chemotherapy induced neutropenia and febrile neutropenia,” commented Philippe Bastide, Head of Biosimilars at Mundipharma International. “The availability of this biosimilar represents an important opportunity to reduce healthcare costs while increasing access to an effective treatment option.”

Matt Fellows

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