Sandoz Triumphs in Patent Dispute, Secures Q4 2026 US Launch for Eylea® Biosimilar

In a landmark victory for patient access and biosimilar competition, Sandoz, a global leader in generic and biosimilar medicines, has reached a definitive agreement with Regeneron Pharmaceuticals, Inc., to resolve all patent litigation in the United States concerning its FDA-approved aflibercept biosimilar, Enzeevu™. This settlement clears a critical hurdle, paving the way for Sandoz to launch its biosimilar version of the blockbuster ophthalmology drug Eylea® in the US market as early as the fourth quarter of 2026.

The legal battle began in August 2024, shortly after the FDA approved Sandoz’s biosimilar. Regeneron initiated patent infringement proceedings under the Biologics Price Competition and Innovation Act (BPCIA), a framework designed to streamline the approval of biosimilars while preserving the patent rights of innovator companies. Regeneron’s lawsuit claimed that Sandoz’s product infringed upon a staggering 46 of its patents, some of which were not set to expire until 2040. After months of vigorous legal defense by Sandoz, the two companies reached a confidential agreement to resolve the dispute, with all litigation now dismissed.

The settlement is a major victory for Sandoz, as it provides a clear and defined timeline for market entry. Enzeevu™ (aflibercept-abzv) received FDA approval on August 12, 2024. It is a biosimilar of Eylea®, indicated for the treatment of neovascular age-related macular degeneration (nAMD), a leading cause of vision loss in older adults. Aflibercept is a recombinant fusion protein that works by inhibiting abnormal blood vessel growth in the eye, thereby improving and maintaining visual acuity.

Interchangeability: A Key Differentiator

A notable aspect of the Sandoz biosimilar is its provisional “interchangeable” status. Under the BPCIA, an interchangeable biosimilar can be substituted for the reference product by a pharmacist without the need for a physician’s intervention, subject to state pharmacy laws. This is a crucial distinction that can dramatically increase patient access and lower costs.

While the FDA provisionally determined that Enzeevu™ is interchangeable with Eylea®, this designation is currently subject to an unexpired exclusivity period for the first interchangeable biosimilar product on the market. Once this period expires, Enzeevu™’s interchangeability status will become active, providing a significant competitive advantage.

The impending entry of biosimilar aflibercept is expected to have a profound impact on the US ophthalmology market. By introducing high-quality, more affordable alternatives to the highly expensive reference medicine, Sandoz aims to lower healthcare costs and make this vital vision-saving treatment more accessible to patients. This move further strengthens Sandoz’s leadership in the US biosimilar market and aligns with the company’s core mission of “pioneering access for patients” through affordable, high-quality medicines.