Clinical Report: Can Patients Switch to Biosimilar Aflibercept?

Overview

Patients with diabetic macular edema who switched to the biosimilar aflibercept MYL-1701P maintained comparable safety and efficacy profiles to those who continued the reference drug during a 20-week extension of the INSIGHT trial.

Background

Diabetic macular edema (DME) is a significant cause of vision loss, and anti-VEGF therapies like aflibercept are standard treatments. The introduction of biosimilars offers potential cost savings and increased access to treatment. Understanding the safety and efficacy of switching from reference to biosimilar agents is crucial for clinical decision-making.

Data Highlights

Key Findings

• Patients switching to MYL-1701P maintained safety and efficacy profiles similar to those continuing the reference drug.
• Adverse events were mostly mild or moderate, with no deaths reported.
• One serious adverse event occurred in the switch group, considered possibly related to treatment.
• No treatment-induced or treatment-boosted antibodies were detected during the study.
• Visual and anatomic improvements from the parent trial were sustained through week 76.

Clinical Implications

The study indicates that switching from reference aflibercept to MYL-1701P does not compromise safety or efficacy in patients with DME.

Conclusion

The findings support the maintenance of treatment efficacy and safety when switching to the biosimilar MYL-1701P in patients with diabetic macular edema.

Related Resources & Content

1. Chauhan R, et al., BMJ Open Ophthalmology, 2024 -- Safety and efficacy of biosimilar aflibercept MYL-1701P in diabetic macular oedema: 20-week extension results following the INSIGHT pivotal trial
2. Retinal Physician — FDA Approves First Biosimilars to Eylea
3. Ophthalmology Management — Aflibercept Biosimilar Shows Equivalent Efficacy in DME Trial
4. Retinal Physician — FDA Approves Anti-VEGF Biosimilar Drug
5. Ophthalmology Management — CMS Establishes New QCode for Aflibercept Biosimilar Yesafili
6. FDA Approves First Biosimilars to Eylea
7. Aflibercept Biosimilar Shows Equivalent Efficacy in DME Trial
8. FDA Approves Anti-VEGF Biosimilar Drug
9. Overview | Diabetic retinopathy: management and monitoring | Guidance | NICE
10. FDA approves first interchangeable biosimilars to Eylea to treat macular degeneration and other eye conditions | FDA
11. Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema: The INSIGHT Randomized Clinical Trial - PubMed
12. Safety and efficacy of biosimilar aflibercept MYL-1701P in diabetic macular oedema: 20-week extension results following the INSIGHT pivotal trial
13. Long-Term Efficacy and Safety of CT-P42 in Patients with Diabetic Macular Edema: 52-Week Results from a Phase 3 Randomized Clinical Trial | Ophthalmology and Therapy | Springer Nature Link
14. Clinical efficacy and safety of aflibercept biosimilars in neovascular age-related macular degeneration: a systematic review and meta-analysis of randomised controlled trials - PubMed