Avastin Biosimilar Demonstrates “Clinical Equivalence”

A biosimilar for a monoclonal antibody (mAb) that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors was found to be clinically equivalent to Avastin (bevacizumab) for the treatment of non-squamous non-small cell lung cancer (NSCLC). By blocking the binding of VEGF with its receptors, the mAb prevents the formation of new blood vessels, ultimately cutting off the blood supply to growing tumors.

ABP 215 is one of the four oncology biosimilars on which Amgen and Allergan are collaborating. Avastin is approved by FDA for six cancer indications, and has also been widely used off-label as an alternative to Lucentis (ranibizumab) for the treatment of “wet” age-related macular degeneration (AMD). Although it is likely that FDA will allow extrapolation of indications for bevacizumab, ABP 215 must have the same relevant mechanism of action for the active substance and the target receptor(s) as the originator biologic for extrapolation to be feasible.

Avastin was Roche’s second top-seller in 2014, posting sales of $6.4 billion that year. Boehringer Ingelheim, Pfizer, Novartis/Sandoz, AZN/Fujifilm, Oncobiologics, and Epirus are all also developing their own versions of biosimilars for bevacizumab.

Source: Amgen