www.fdanews.com/articles/179373-amgen-and-allergan-submit-biosimilar-bla-for-abp-215-to-fda
Amgen and Allergan Submit Biosimilar BLA for ABP 215 to FDA
November 18, 2016
Amgen and Allergan have submitted a biologics license application (BLA) to the FDA for ABP 215, a biosimilar candidate to Avastin.
No clinically meaningful difference to Avastin.
In December 2011, Amgen and Allergan formed a collaboration to develop and commercialize four oncology antibody biosimilar medicines.
Under the terms of the agreement, Amgen will assume primary responsibility for developing, manufacturing and initially commercializing the oncology antibody products.