Opuviz Biosimilar Launch Set for 2027 in US | Ophthalmology News

The U.S. Market is set to gain another biosimilar option for the treatment of retinal diseases, with Samsung Bioepis securing a path to launch its Opuviz (aflibercept-yszy) in January 2027. This follows a settlement and license agreement with Regeneron Pharmaceuticals, resolving patent disputes related to the biosimilar referencing Eylea (aflibercept).

Opuviz, approved by the FDA in May 2024, is designed as a biosimilar to Eylea, a widely used biologic therapy for conditions like wet age-related macular degeneration (AMD) and diabetic macular edema (DME). The agreement allows Samsung Bioepis to move forward with the U.S. Launch after previously securing agreements for Europe and the rest of the world.

“As with ranibizumab biosimilars, aflibercept biosimilars have the potential to significantly improve accessibility and affordability for patients,” said Thomas Newcomer, vice president and head of U.S. Commercial operations at Samsung Bioepis. “As demand for treatment continues to grow, biosimilars can help manage costs with confidence without compromising on clinical standards.”

The development of biosimilars like Opuviz is driven by the potential to offer more affordable treatment options for patients with retinal diseases. Eylea, and similar anti-VEGF therapies, are crucial in preventing vision loss, but their cost can be a significant barrier to access. Biosimilars, being highly similar but not identical to the original biologic, are manufactured to provide the same clinical effect at a lower price point.

This settlement builds upon a previous agreement between Samsung Bioepis and Regeneron covering markets outside the U.S. The financial terms of the U.S. Agreement have not been disclosed. Opuviz has already been launched in the U.K. In January 2026, with plans for rollout across the rest of Europe in April 2026 and other global markets (excluding Korea) in May 2026.

The approval of Opuviz in 2024 marked a significant step forward in expanding treatment options for retinal diseases. The FDA’s approval process for biosimilars is rigorous, requiring demonstration of high similarity to the reference product in terms of structure, function, and clinical safety, and efficacy.

The introduction of Opuviz in the U.S. Market in 2027 is expected to increase competition and potentially lower costs for patients requiring anti-VEGF therapy. This is particularly important given the increasing prevalence of AMD and DME, both of which are leading causes of vision loss in older adults. The availability of more affordable biosimilars can help ensure that more patients have access to the treatments they need to preserve their sight.

Harrow also entered into a commercialization agreement with Samsung Bioepis in July 2025 to secure the exclusive U.S. Commercial rights to both Opuviz and Byooviz (ranibizumab-nuna), a biosimilar referencing Lucentis (ranibizumab). Harrow expects to assume full commercial responsibility for both biosimilars by the end of 2025, following the transition of commercial rights from Biogen back to Samsung Bioepis. This acquisition strengthens Harrow’s position as a leading provider of ophthalmic pharmaceuticals in the U.S.

The landscape of ophthalmic treatments is evolving with the increasing availability of biosimilars. These therapies offer the potential to improve patient access and affordability, while maintaining the clinical benefits of the original biologic drugs. The launch of Opuviz in 2027 represents another step in this direction, offering hope for more accessible and cost-effective treatment options for individuals with retinal diseases.