Amgen and Allergan receive EU approval for cancer biosimilar Mvasi

Amgen and Allergan have received European regulatory approval for Mvasi, a new biosimilar drug for the treatment of certain types of cancer.

The European Commission has granted marketing authorisation for Mvasi in combination with chemotherapy for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, ovarian cancer and other disease types.

Mvasi is the first biosimilar version of bevacizumab approved in Europe, with the decision coming after Amgen and Allergan were able to prove that their biosimilar offers no clinically meaningful differences in terms efficacy, safety and immunogenicity compared to the original version of bevacizumab.

Dr Sean Harper, executive vice-president of research and development at Amgen, said: "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."

Amgen and Allergan are collaborating on the development and commercialisation of four oncology biosimilars, as part of a portfolio of ten biosimilars that Amgen is creating. Two of these have already been approved by the European Commission.

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