Amgen and Allergan were granted marketing authorization from the European Commission 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, including in combination with chemotherapy or other therapies for metastatic carcinoma of the colon or rectum, metastatic breast cancer, non-squamous non-small cell lung cancer (NSCLC), renal cell cancer, ovarian, fallopian tube, or primary peritoneal cancer, or metastatic carcinoma of the cervix.
 
The approval was based on a data package that demonstrated MVASI and bevacizumab are highly similar, with no clinically meaningful differences in terms of the efficacy, safety and immunogenicity. Clinical studies included results from a Phase III trial in patients with non-squamous NSCLC.
 
In September 2017, MVASI became the first anti-cancer biosimilar, as well as the first biosimilar bevacizumab, to be approved by the FDA. 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.

“The European Commission’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,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “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.”