European Commission approved Amgen and Allergan’s biosimilar

| By | Cancer Drugs, Drug Quality Control

Amgen and Allergan plc. today announced that the European Commission (EC) 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, including metastatic carcinoma of the colon or rectum;  unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC); advanced, metastatic or recurrent non-squamous NSCLC; advanced and/or metastatic renal cell cancer; advanced, platinum-sensitive, or platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; persistent, recurrent, or metastatic carcinoma of the cervix.

“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.”

Approval from the EC grants a centralized marketing authorization with unified labeling in the 28 countries that are members of the European Union (EU). Norway, Iceland and Liechtenstein, as members of the European Economic Area, will take corresponding decisions on the basis of the decision of the EC.

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