Amgen, Allergan File Avastin Biosimilar With EMABy
Amgen and Allergan have submitted a marketing authorization application to the European Medicines Agency (EMA) for ABP 215, a biosimilar candidate to Avastin (bevacizumab), Roche’s blockbuster anti-cancer biologic. Avastin is Roche’s top-selling drug with 2015 sales of CHF 6.68 billion ($6.56) billion.
The EMA filing follows an earlier filing for a biosimilar of bevacizumab by Amgen and Allergan in November 2016 to the US Food and Drug Administration.
ABP 215 is a recombinant immunoglobulin G1 monoclonal antibody that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2. This is believed to inhibit the establishment of new blood vessels that maintain and nurture growth of solid tumors, according to the companies.
Bevacizumab is approved in the US, European Union, and other regions for treating patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer as well as metastatic carcinoma of the colon or rectum; metastatic renal cell carcinoma; and other region-specific indications.
Amgen and Allergan had formed a collaboration in December 2011 to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines. Under the agreement, Amgen will assume primary responsibility for developing, manufacturing, and initially commercializing the oncology antibody products.