FDA approves Mvasi (bevacizumab-awwb) biosimilar for non-small cell lung cancer, for metastatic colorectal cancer, glioblastoma, metastatic renal cell carcinoma and carcinoma of the cervix.- Amgen and Allergan.

Amgen and Allergan announced that the FDA has approved Mvasi (bevacizumab-awwb) for all eligible indications of the reference product, Avastin (bevacizumab). Mvasi is the first anti-cancer biosimilar, as well as the first bevacizumab biosimilar, approved by the FDA. Mvasi is approved for the treatment of five types of cancer, including in combination with chemotherapy for non-squamous non-small cell lung cancer (NSCLC), in combination with chemotherapy for metastatic colorectal cancer (mCRC), glioblastoma, metastatic renal cell carcinoma in combination with interferon alfa and in combination with chemotherapy for persistent, recurrent, or metastatic carcinoma of the cervix.

The approval of Mvasi was based on a comprehensive data package that demonstrated Mvasi and 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 III trial in patients with NSCLC.