Regeneron and Sandoz Reach Settlement on Eylea Biosimilar, Shaping Future of Eye Disease Treatment Market

Sandoz to Launch Eylea Biosimilar by End of 2026

Regeneron Pharmaceuticals and Sandoz have reached a settlement agreement that resolves all patent litigation related to Sandoz's biosimilar version of the eye disease drug Eylea. The agreement allows Sandoz to launch its biosimilar, Enzeevu, in the fourth quarter of 2026 or potentially earlier under certain circumstances. This development marks a significant milestone in the ongoing competition within the ophthalmology market.

The settlement puts an end to a legal dispute that began in August 2024, shortly after the FDA approved Enzeevu. Regeneron had initially claimed that Sandoz infringed on 46 of its patents, some of which were set to expire as late as 2040. The resolution of this conflict paves the way for increased competition in the treatment of various eye conditions, including age-related macular degeneration and diabetic macular edema.

Biosimilar Landscape and Market Dynamics

The introduction of Enzeevu as an interchangeable biosimilar represents a significant shift in the market. As an interchangeable product, it can be substituted for Eylea at the pharmacy level without requiring a new prescription from a doctor. This designation is expected to facilitate broader access to treatment options for patients.

Regeneron is already facing competition from Amgen's biosimilar, Pavblu, which launched in November 2024 after a legal setback for Regeneron. Pavblu has made a notable impact on the market, generating $229 million in revenue during the first half of 2025. Concurrently, Regeneron's Eylea sales have experienced a substantial decline, dropping from $1.19 billion in Q4 2024 to $754 million in Q2 2025.

The competitive landscape extends beyond Sandoz and Amgen, with several other companies developing Eylea biosimilars. Biocon Biologics has secured a settlement to commercialize its interchangeable biosimilar, Yesafili, in the second half of 2026. Additionally, Biogen, Samsung Bioepis, Celltrion, and Formycon are all working on their own versions of Eylea biosimilars, further intensifying the market competition.

Regeneron's Strategy and Market Challenges

In response to the growing competition, Regeneron has introduced a high-dose (8-mg) version of Eylea, known as Eylea HD. This formulation remains under patent protection but faces strong competition from Roche's Vabysmo, which has demonstrated impressive sales of 2.1 billion Swiss francs ($2.4 billion) worldwide in the first half of 2025.

The impact of these market dynamics is evident in Regeneron's financial performance. The combined U.S. sales of both Eylea formulations totaled $2.5 billion in the first half of 2025, a notable decrease from the $3.1 billion reported for the same period in 2022, coinciding with Vabysmo's market entry.

As the ophthalmology market continues to evolve, the introduction of multiple biosimilars and next-generation treatments is expected to reshape the competitive landscape, potentially leading to increased access and affordability for patients requiring these vital eye disease therapies.