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Amgen and Allergan win first EU approval for Avastin biosimilar

Mvasi, their version of Roche's blockbuster, is licensed for six types of cancers

Amgen

European regulators have approved Amgen and Allergan’s version of Roche’s biggest-selling cancer drug Avastin (bevacizumab).

Mvasi (bevacizumab), a monoclonal antibody, becomes the first bevacizumab biosimilar approved by the European Commission and is indicated to treat six cancer types, including colon, rectum, breast and lung cancer.

The move builds on its US success, which saw it became the first anti-cancer biosimilar, as well as the first biosimilar of bevacizumab, to be approved by the Food and Drug Administration (FDA) last September.

Sean Harper, executive vice president of research and development at Amgen, said: “The EC’s approval of Mvasi marks a significant milestone for both Amgen and the oncology community, providing a biosimilar for a medicine which is used across multiple types of cancer.

“Mvasi is the first targeted cancer biosimilar from Amgen’s portfolio approved in Europe, underscoring our commitment to delivering high-quality medicines that address some of the most serious illnesses.”

The approval was based on data showing Mvasi and beveacizumab are highly similar, with no clinically meaningful differences in terms of efficacy, safety and immunogenicity between the products.

David Nicholson, chief research and development officer at Allergan, said: “Mvasi is the first product from our collaboration with Amgen to receive marketing authorisation from the European Commission, highlighting the success of our join commitment to developing cancer biosimilars.

“We look forward to our continued work with Amgen and to providing important medicines to patients in the future.”

Back in December 2011, Amgen and Allergan entered into a collaboration to develop and commercialise four oncology antibody biosimilars.

Since then, Amgen has also seen success with Amgevita - a biosimilar of AbbVie’s blockbuster Humira - which became Europe’s first approved Humira biosimilar.

Article by
Gemma Jones

22nd January 2018

From: Regulatory

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