Amgen and Allergan have obtained marketing authorisation from the European Commission (EC) for biosimilar MVASI to treat select cancer types in the European Union (EU).
MVASI is a biosimilar to bevacizumab, a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to vascular endothelial growth factor (VEGF).
Bevacizumab blocks the interaction between VEGF and its receptors to inhibit the formation of new blood vessels required by solid tumours for their maintenance and growth.
The EC authorisation indicates the use of MVASI in combination with various other anticancer therapies for metastatic carcinoma of the colon or rectum, breast cancer, renal cell cancer and unresectable advanced non-squamous non-small cell lung cancer (NSCLC).
The permit also covers the treatment of advanced, platinum-sensitive, or platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer; and persistent, recurrent or metastatic cervix carcinoma.
Amgen research and development executive vice-president Sean Harper said: “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.
“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.”
Prior to the approval, the EC reviewed a comprehensive data package that reportedly demonstrated the similarity between MVASI and bevacizumab.
The agency did not find any clinically meaningful differences in the efficacy, safety and immunogenicity of the products.