FDA has approved first Avastin biosimilar

September 18, 2017 8:55 AM

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Amgen and Allergan plc. has announced that the U.S. Food and Drug Administration (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 marks a significant milestone for healthcare practitioners and patients as the first anti-cancer biosimilar approved in the United States,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “With decades of experience in oncology and biologics, Amgen continues to expand its biosimilar and oncology portfolios, and MVASI has the potential to advance access to high-quality, targeted cancer therapy.”

Amgen is committed to developing high-quality biosimilars with a robust analytic and clinical package. Approval is based on the totality of evidence which includes structure, function, toxicity, pharmacokinetics, pharmacodynamics, immunogenicity, clinical safety and efficacy.1 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 3 trial in patients with NSCLC.

“MVASI is the first product from our collaboration with Amgen to be approved by the FDA and underscores our joint commitment to bring cancer biosimilars to market to help patients,” said David Nicholson, chief research and development officer at Allergan. “We are committed to developing safe and effective therapies in critical disease areas, and MVASI is leading the way for additional oncology biosimilars from Amgen and Allergan.”

Amgen and Allergan’s bevacizumab biosimilar is also undergoing review by the European Medicines Agency, following a Marketing Authorization Application submitted in December 2016. The companies 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 FDA including MVASI.

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