European Commission approves Opuviz as aflibercept biosimilar
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Key takeaways:
- Opuviz was approved in Europe for wet AMD and vision loss related to other retinal conditions.
- It is the second European-approved ophthalmology biosimilar under Samsung Bioepis and Biogen’s partnership.
The European Commission has approved Opuviz 40 mg/mL solution, a biosimilar referencing Eylea, according to a press release from Samsung Bioepis and Biogen.
“Opuviz aims to address key unmet needs in retina care by offering a cost-effective alternative to existing biologics, potentially improving access for patients who may face barriers due to high treatment costs,” a spokesperson for Samsung Bioepis told Healio. “It provides a quality-proven, safe and effective treatment option for managing conditions like neovascular age-related macular degeneration and diabetic macular edema, where long-term treatment adherence is crucial but often hindered by affordability and availability.”
Opuviz (aflibercept), also known as SB15, is approved to treat wet AMD as well as vision loss due to macular edema secondary to retinal vein occlusion, DME and myopic choroidal neovascularization.
The European Commission (EC) approval was supported by positive analytical, nonclinical and clinical data, including a phase 3 study in which Opuviz met its primary endpoint of change from baseline in best corrected visual acuity at week 8; 32-week and 56-week analyses also demonstrated comparability to reference Eylea (aflibercept, Regeneron) in other efficacy, safety, immunogenicity and pharmacokinetics endpoints.
Opuviz is the second EC-approved ophthalmology biosimilar in Samsung Bioepis’ portfolio with commercialization rights held by Biogen, with an earlier approval for Byooviz (ranibizumab), according to the release.
“The biosimilar’s availability could help health care systems manage budgets more effectively while maintaining the efficacy and safety standards critical to retinal therapies,” the spokesperson said.
As Healio previously reported, the FDA approved Opuviz in May.
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