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Samsung Bioepis Shares 1-Year Phase 3 Results for Eylea Biosimilar


At the 2023 Association for Research in Vision and Ophthalmology Annual Meeting, Samsung Bioepis shared comparable safety, efficacy, and immunogenicity data through 1 year between its aflibercept biosimilar (SB15) and the originator (Eylea).

Samsung Bioepis shared positive 1-year results from a phase 3 trial confirming the biosimilarity between the company’s aflibercept biosimilar and the originator (Eylea) at the 2023 Association for Research in Vision and Ophthalmology Annual Meeting.

The conference was held April 23-27, 2023, in New Orleans, Louisiana.

Aflibercept is used to treat neovascular age-related macular degeneration (nAMD), a retinal disease that is one of the commonest causes of blindness throughout the world, affecting more than 200 million people globally.

Researchers presented 56 weeks of results from the study. The publication comes after 32-week interim results from the same study were presented at last year’s American Academy of Ophthalmology Annual Meeting in September 2022.

Of a total of 449 patients with nAMD, 438 were randomized to receive either the originator or the biosimilar. At week 32, patients receiving the originator were randomized again to either continue their regimen or switch from to the biosimilar. The biosimilar-only group had 219 patients, the originator-to-biosimilar group had 111, and the originator-only group had 108. Overall, 425 patients were followed through week 56.

The primary efficacy end points were change from baseline in best corrected visual acuity (BCVA), change from baseline in central subfield thickness (CST), and proportion of patients with intra/sub-retinal fluid. Up to week 56, improvements in BCAVA were comparable between all treatment arms. In the group that switched from the originator to the biosimilar, the least square mean change from baseline CST was “well maintained and comparable to the continuing group.”

Additionally, the safety, immunogenicity, and pharmacokinetic profiles of SB15 were clinically similar to the reference product, and no treatment-induced or treatment-boosted anti-drug antibodies developed in the switching group after week 32.

Samsung Bioepis also shared new data on the similarity between SB15 and Eylea in terms of structural and physiochemical properties and biological function at the meeting, showing that the biosimilar had high similarity to the reference product with respect to structural, physiochemical, and biological properties.

“The presentations showcase our ongoing commitment in ophthalmology to bring more access to treatments for patients suffering from retinal vascular diseases…. Biosimilars are relatively new in ophthalmology compared to other therapeutic areas, and we will continue to advance with our scientific research, publication and educational activities to bring more awareness of biosimilars among ophthalmologists,” said Jin-Ah Jung, medical affairs group leader at Samsung Bioepis, in a statement.

In November 2019, Samsung Bioepis entered into a commercialization agreement for SB15 and SB11, a ranibizumab biosimilar also used to treat nAMD as well as other ophthalmic conditions. SB11, also known as Byooviz, references Lucentis and is currently available on the US, EU, and Canadian markets.

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