The U.S. Food and Drug Administration announced it has approved Amgen Inc.’s biosimilar drug Mvasi for treatment of multiple types of cancer. It is the first biosimilar approved in the U.S. for cancer.
Mvasi is a biosimilar to Avastin, manufactured by Genentech in San Francisco, a wholly owned subsidiary of Roche Holding AG. Avastin was first approved by the FDA in 2004 for the treatment of certain lung, renal and ovarian cancers.
Biosimilars are products that are similar to already FDA approved product, with “no clinically meaningful difference in terms of safety and effectiveness,” according to the FDA. While generics are copies of existing drugs, and have the same active ingredients, biosimilars are drugs manufactured inside cell cultures, and thus are similar but not identical to the original drugs.
Approval of Mvasi is likely to disrupt Avastin’s reported sales of $6.7 billion last year. Avastin’s first direct competitor, Mvasi was created under Amgen and Allergan plc’s collaboration started in 2011 to develop four oncology biosimilars. Allergan is headquartered in Dublin, Ireland.
“Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower healthcare costs and increase access to important therapies,” said FDA Commissioner Scott Gottlieb in a statement.
Sean Harper, Amgen’s executive vice president of research and development, said the company will continue to expand its biosimilar and oncology portfolios.
“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 Harper in a statement.
Shares of Amgen (AMGN) on Thursday closed down 26 cents, or less than 1 percent, to $189.44 on the Nasdaq.