The decision, which is in line with a recommendation made by the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) in July, clears Mvasi for the treatment of the same cancers as Avastin.
The approval states that the mAb is a biosimilar but not interchangeable with the Roche drug.
Amgen developed Mvasi in collaboration with Allergan under a deal signed in 2010. The agreement covered the development of four cancer biosimilars.
An Amgen spokeswoman told us "In the collaboration with Allergan, Amgen has primary responsibility for the development, manufacture and initial commercialization of the products; whereas Allergan will provide funding over the course of development as well as expertise gained in the commercialization and marketing of products."
She declined to comment when asked when Mvasi would be launched in the US or if it would be sold at a discounted rate relative to the innovator drug.
"The FDA’s approval is an exciting step towards recognizing Mvasi as an important treatment option for certain patients with cancer. The patent information exchange under the regulatory scheme governing biosimilars (the BPCIA) is ongoing. We have not commented on launch timelines."
In December, Amgen announced that it Mvasi – previously known as ABP 215 – submitted for review by the European Medicines Agency (EMA).