The regulator approved two interchangeable biosimilars to Regeneron’s Eylea, providing additional competition for the pharma’s blockbuster as key patent protections are set to expire.
Tag Archive for: aflibercept
The U.S. Department of Justice announced Wednesday it has filed a False Claims Act complaint against Regeneron Pharmaceuticals, alleging that the company “fraudulently inflated Medicare reimbursement rates” for its eye therapy Eylea (aflibercept).
The appellate court sided with Regeneron, agreeing with the pharma that a district court had wrongly dismissed its antitrust claims against Novartis because anti-VEGF therapies sold in pre-filled syringes (PFS) constitute their own and distinct market versus therapies sold in vials.
Citing issues with a third-party contractor, the FDA rejected Regeneron’s regulatory application for a higher-dose regimen of Eylea, the company’s blockbuster eye injection treatment.
As competition eats away at profits for the wet age-related macular degeneration drug, Regeneron is diversifying its portfolio and pumping more money into research and development.