Amgen, Allergan launch first anti-cancer biosims in U.S.

Jul 19, 2019

Amgen and Allergan have announced the launch of Mvasi, a bevacizumab biosimilar referencing Avastin, and Kanjinti, a trastuzumab biosimilar referencing Herceptin, in the United States.

According to the Amgen–Allergan partnership, the list price of both products will be 15 percent lower than their respective reference products.

Mvasi was the first bevacizumab biosimilar—and the first anticancer biosimilar—to be authorized in the United States, earning the FDA’s approval in September 2017. Kanjinti earned its approval in June 2019 after the drug makers first received a Complete Response Letter for the product in 2018 and subsequently worked with the agency to address its concerns.

Herceptin-maker Genentech recently filed a motion for a temporary restraining order and a motion for a preliminary injunction against Amgen, in a Biologics Price Competition and Innovation Act litigation related to patents covering Herceptin.

Read the Center for Biosimilars coverage