Samsung Bioepis reaches settlement agreement for Eylea (aflibercept) biosimilar

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Samsung Bioepis has entered into settlement and license agreements with Regeneron—and separately with Regeneron and Bayer—clearing a path for commercialization of its aflibercept biosimilar across the United States, Europe, and other global markets. Under the US agreement, OPUVIZ (aflibercept-yszy), a biosimilar to Eylea (aflibercept) 2 mg, may launch in January 2027. A separate ex-US settlement enables launch in the United Kingdom beginning January 2026, in the rest of Europe from April 2026, and in other settled markets (excluding Korea) from May 2026.

For retina specialists and health systems, the agreements establish defined timelines for additional aflibercept biosimilar competition in major markets. Given the central role of anti–vascular endothelial growth factor (VEGF) therapy in neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), diabetic retinopathy (DR), and macular edema secondary to retinal vein occlusion (RVO), biosimilar entry may influence procurement strategies and payer policies.¹⁻³

Regulatory Overview

In the United States, aflibercept-yszy received Food and Drug Administration (FDA) approval in May 2024 as a biosimilar to Eylea (aflibercept) 2 mg (40 mg/mL).⁴ The newly announced settlement resolves patent litigation and permits commercial launch in January 2027; financial terms were not disclosed.

Outside the United States, Samsung Bioepis’ aflibercept biosimilar (SB15; aflibercept 40 mg/mL solution) was approved by the European Commission in November 2024 and by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in April 2025.⁵⁻⁶ The settlement with Regeneron and Bayer enables staged launches beginning in early 2026 across the United Kingdom, the European Union, and other agreed territories. As with other biosimilars authorized in the European Union, approval would have required demonstration of biosimilarity to the reference product based on analytical, nonclinical, and clinical comparability data under the European Medicines Agency (EMA) framework.⁷

Clinical Context: Anti-VEGF Therapy in Retinal Disease

Aflibercept is a recombinant fusion protein that binds VEGF-A, VEGF-B, and placental growth factor, thereby inhibiting angiogenesis and vascular permeability.⁸ The reference product, Eylea, was first approved by the FDA in 2011 for nAMD and subsequently for DME, DR, and macular edema following RVO.⁸

The pivotal VIEW 1 and VIEW 2 trials demonstrated that aflibercept 2 mg administered every 8 weeks after 3 monthly loading doses was noninferior to monthly ranibizumab in maintaining vision in nAMD.⁹ These data established extended-interval dosing as a standard approach in many retina practices.

Globally, nAMD and diabetic eye disease contribute substantially to vision impairment and blindness.¹⁻² The chronic nature of these conditions necessitates frequent intravitreal injections, resulting in significant cumulative treatment costs. In the United States, anti-VEGF therapies account for substantial Medicare Part B drug expenditures.¹⁰ Similar cost pressures exist within publicly funded European health systems.

Biosimilars are intended to introduce price competition while maintaining comparable safety and efficacy profiles. Regulatory agencies in both the United States and European Union require demonstration of high similarity to the reference product, with no clinically meaningful differences in safety, purity, or potency.⁷˒¹¹ Extrapolation of indications is permitted when scientifically justified.

Drug-Class and Market Considerations

Aflibercept’s mechanism as a soluble decoy receptor distinguishes it structurally from monoclonal antibody–based anti-VEGF agents but results in a shared therapeutic target.⁸ In 2023, a higher-dose 8-mg formulation of aflibercept (Eylea HD) was approved in the United States for extended dosing intervals in certain indications.¹² How biosimilar competition in the 2-mg segment will interact with the uptake of higher-dose branded formulations remains to be determined.

Ranibizumab biosimilars have already entered US and European markets, demonstrating that ophthalmology can support biosimilar adoption under appropriate reimbursement and contracting structures.¹³ However, interchangeability designations, physician familiarity, payer mandates, and real-world pharmacovigilance data all influence uptake.

At the time of writing, aflibercept-yszy has been approved as a biosimilar in the United States; interchangeability status should be verified in the FDA Purple Book database, as this designation may affect substitution practices at the pharmacy level.¹⁴

Interpretation and Remaining Questions

The newly disclosed agreements provide clarity on launch timing but do not immediately affect current prescribing. US clinicians will not see commercial availability of aflibercept-yszy until 2027. In contrast, UK and EU clinicians may encounter the product as early as 2026, contingent on national reimbursement decisions and local contracting.

Key unanswered questions include pricing strategy, formulary positioning, and the extent of anticipated cost differentials relative to the reference product. Additionally, although biosimilar approval is based on rigorous comparability exercises, long-term real-world safety and immunogenicity monitoring will remain important, particularly in high-volume intravitreal injection settings.

Limitations

The company announcement did not disclose detailed clinical comparability data, pricing projections, or specific patent terms. While regulatory approvals in the United States, European Union, and United Kingdom are documented, direct public assessment reports detailing the full comparability data set should be consulted for comprehensive evaluation.⁴⁻⁶

References

1. Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection. Lancet Glob Health. 2014;2(2):e106-e116. https://doi.org/10.1016/S2214-109X(13)70145-1

2. Yau JWY, Rogers SL, Kawasaki R, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012;35(3):556-564. https://doi.org/10.2337/dc11-1909

3. Rogers S, McIntosh RL, Cheung N, et al. The prevalence of retinal vein occlusion. Ophthalmology. 2010;117(2):313-319.e1. https://doi.org/10.1016/j.ophtha.2009.07.017

4. US Food and Drug Administration. Biosimilar product information: aflibercept-yszy. https://www.fda.gov/drugs/biosimilar-product-information

5. European Commission. Union Register of medicinal products for human use. https://ec.europa.eu/health/documents/community-register/html/

6. UK Medicines and Healthcare products Regulatory Agency. Products. https://products.mhra.gov.uk/

7. European Medicines Agency. Biosimilar medicines: overview. https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview

8. US Food and Drug Administration. Eylea (aflibercept) prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125387s082lbl.pdf

9. Heier JS, Brown DM, Chong V, et al. Intravitreal aflibercept (VEGF Trap-Eye) in wet age-related macular degeneration. Ophthalmology. 2012;119(12):2537-2548. https://doi.org/10.1016/j.ophtha.2012.09.006

10. US Government Accountability Office. Medicare Part B: expenditures for drugs with high spending growth. https://www.gao.gov/products/gao-20-111

11. US Food and Drug Administration. Biosimilars and interchangeable products. https://www.fda.gov/drugs/biosimilars

12. US Food and Drug Administration. FDA approves Eylea HD (aflibercept 8 mg). 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-eylea-hd

13. US Food and Drug Administration. Ranibizumab biosimilar approvals. https://www.fda.gov/drugs/biosimilar-product-information

14. US Food and Drug Administration. Purple Book: database of licensed biological products. https://purplebooksearch.fda.gov/