November 21, 2023
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FDA approves Amgen cancer treatment biosimilar Mvasi


The U.S. Food and Drug Administration approved a cancer treatment biosimilar developed in partnership between Allergan and Thousand Oaks-based Amgen, the company announced Sept. 13.

Mvasi was approved to treat five types of cancer in combination with other therapies.

“The approval of Mvasi marks a significant milestone for healthcare practitioners and patients as the first anti-cancer biosimilar approved in the United States,” Sean Harper, executive vice president of research and development at Amgen, said in a news release. “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.”

The European Medicines Agency is currently reviewing a marketing authorization application for Mvasi. In addition to Mvasi and its Humira biosimilar Amjevita, Amgen has another eight biosimilars in its portfolio, including four oncology biosimilars it is developing in partnership with Allergan.

“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.”

Mvasi was shown to be highly similar to the Genentech cancer drug Avastin. In February, the Roche AG subsidiary sued Amgen over its investigation into whether the biosimilar violated Avastin patents. Sales for Avastin reached $6.8 billion in 2016.

The FDA granted Amgen its first biosimilar approval last September for Amjevita, which treats patients with inflammatory diseases like rheumatoid arthritis. AbbVie, the maker of Humira, later sued, saying that it violated the Biosimilar Price Competition and Innovation Act.

Unlike generics, biosimilars are biological products designed to replicate existing treatments and reduce costs. Biosimilars for Amgen’s cancer treatment Neupogen and rheumatoid arthritis drug Enbrel have also been approved for use in the U.S.

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