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Home Industry News Mylan files for EU approval of biosimilar version of pegfilgrastim

Mylan files for EU approval of biosimilar version of pegfilgrastim

22nd July 2016

Mylan has announced that the European Medicines Agency has accepted its marketing authorisation application for a proposed biosimilar version of pegfilgrastim.

The therapy is designed 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.

It was co-developed with Biocon as one of six biosimilars and generic insulin analogues being jointly researched by the two companies.

The application includes positive clinical data from pivotal pharmacokinetic/pharmacodynamic and confirmatory efficacy, safety and immunogenicity studies completed earlier in 2016.

Mylan president Rajiv Malik said: "We continue to make great progress across our biosimilars portfolio, which represents one of the industry's largest and most diversified portfolios in development."

The company has exclusive commercialisation rights for the proposed biosimilar pegfilgrastim in the US, Canada, Japan, Australia, New Zealand and Europe, with Biocon handling its sale in other parts of the world.ADNFCR-8000103-ID-801822315-ADNFCR

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