BLA for Bevacizumab Biosimilar Filed Based on Phase 3 NSCLC Data

Amgen and Allergan have announced that they have submitted a Biologics License Application (BLA) for ABP 215, a biosimilar to bevacizumab (Avastin).

“ABP 215 is one of 4 oncology biosimilars in our pipeline, and today’s BLA submission is an important milestone as Amgen seeks to expand our oncology portfolio,” Sean E. Harper, MD, executive vice president of Research and Development at Amgen, said in a press release. “ABP 215 has the potential to offer an additional high-quality therapeutic option for patients diagnosed with cancer, continuing Amgen’s mission of providing patients with vital medicines.”

Similar to bevacizumab, ABP 215 is a recombinant immunoglobulin G1 monoclonal antibody that binds the vascular endothelial growth factor to prevent the interaction of VEGF with its receptors, VEGF receptor-1 and 2, thus inhibiting establishment of new blood vessels necessary for the maintenance and growth of solid tumors.

The phase 3 comparative efficacy, safety, and immunogenicity study, which is now under review at the FDA, was conducted in adult patients with non-squamous non-small cell lung cancer (NSCLC). The phase 3 study confirmed that ABP 215 could meet the primary study end point of objective response rate, which was comparable with bevacizumab. Additionally, the 2 antibodies were had similar safety profiles.

Bevacizumab is approved in the United States, Europe, and some other regions around the world for the treatment of patients with unresectable, locally advanced, recurrent, or metastatic non-squamous NSCLC, as well as metastatic carcinoma of the colon or rectum, metastatic renal cell carcinoma, and other region-specific indications.

Beyond ABP 215, Amgen and Allergan are collaborating on the development and commercialization of 3 other oncology biosimilars. Of the 9 biosimilars that Amgen is independently developing, 1 is FDA approved (adalimumab-atto) and 8 remain in the development phase. Allergan, too, has its own biosimilar pipeline.