A biologics license application (BLA) has been filed with the FDA for ABP 215 (Amgen/Allergan), a biosimilar candidate to bevacizumab (Avastin, Genentech). The product’s developers believe that this is the first bevacizumab biosimilar application to be submitted to the agency.
Bevacizumab is a recombinant immunoglobulin G1 (IgG1) monoclonal antibody that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF-1 and VEGF-2, thereby inhibiting the angiogenesis necessary for the maintenance and growth of solid tumors.
The BLA submission included analytical, pharmacokinetic, and clinical data, as well as pharmacology and toxicology data. A phase 3 comparative efficacy, safety, and immunogenicity study was conducted in adults with nonsquamous non–small-cell lung cancer (NSCLC). The study confirmed that there were no clinically meaningful differences between ABP 215 and bevacizumab in terms of efficacy, safety, and immunogenicity.
Bevacizumab is approved in the U.S for the treatment of patients with unresectable, locally advanced, recurrent or metastatic nonsquamous NSCLC as well as for the treatment of patients with metastatic carcinoma of the colon or rectum; metastatic renal-cell carcinoma; and other region-specific indications.
Source: Amgen; November 15, 2016.