Amgen and Allergen have filed with European regulators what they believe is the first biosimilar candidate of Roche's cancer blockbuster Avastin.
ABP 215 is a biosimilar of bevacizumab, a recombinant immunoglobulin G1 monoclonal antibody that binds to vascular endothelial growth factor and inhibits its interaction with receptors, thus inhibiting establishment of new blood vessels necessary for the maintenance and growth of solid tumours.
Avastin is approved in the US and EU for non-squamous non-small cell lung cancer (NSCLC), carcinoma of the colon or rectum, and kidney cancer, and is also cleared for other region-specific indications, which collectively pull in annual sales approaching $7 billion.
The submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data, the firm's said, and noted that the Phase III comparative efficacy, safety and immunogenicity study - carried out in adult patients with non-squamous NSCLC - confirmed "no clinically meaningful difference to bevacizumab".
Industry observers are keeping a very close eye on the advent of biosimilars which, given that they are generally priced 20-30 percent cheaper than their branded counterparts, could help reign in spiralling drug costs and widen access to biologic drugs.
A study published last year by the RAND Corporation research institute predicts that biosimilars could cut US spending on biologics by as much as $44 billion over the next decade.