Amgen (AMGN) and Allergan plc. (AGN) announced Thursday that the European Commission has granted marketing authorization for MVASI (biosimilar bevacizumab).
MVASI is the first biosimilar bevacizumab approved by the EC and is approved for the treatment of certain types of cancers. This includes in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum; in combination with paclitaxel for metastatic breast cancer; and in combination with platinum-based chemotherapy for unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer, among others.
The EC approved MVASI based on a comprehensive data package that demonstrated MVASI and Avastin (bevacizumab) are highly similar, with no clinically meaningful differences in terms of the efficacy, safety and immunogenicity between the products. Clinical studies included results from a Phase 3 trial in patients with non-squamous NSCLC.
Amgen and Allergan said they are committed to developing high-quality biosimilars with a robust analytic and clinical package.
Amgen noted that MVASI is the first targeted cancer biosimilar from the company's portfolio approved in Europe.
Approval from the EC grants a centralized marketing authorization with unified labeling in the 28 countries that are members of the European Union. Norway, Iceland and Liechtenstein, as members of the European Economic Area, will take corresponding decisions on the basis of the decision of the EC.
In September 2017, MVASI became the first anti-cancer biosimilar, as well as the first biosimilar bevacizumab, to be approved by the U.S. Food and Drug Administration.
Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, two of which have been approved by the EC.
David Nicholson, chief research and development officer at Allergan, said, "MVASI is the first product from our collaboration with Amgen to receive marketing authorization from the European Commission, highlighting the success of our joint commitment to developing cancer biosimilars."
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