ARVO 2023: One-year outcomes of Phase 3 study for proposed biosimilar to aflibercept

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Samsung Bioepis Co. has announced that 1-year outcomes of the Phase 3 study for SB15, a proposed biosimilar to Eylea(aflibercept), were presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in New Orleans.

In addition, the company noted new analytical data on similarity between SB15 and reference product in terms of structural and physicochemical properties and biological functions were also presented.

At the meeting, researchers presented 56-week results from the Phase 3 clinical study between SB15 and reference aflibercept (AFL) in terms of efficacy, safety, immunogenicity, and pharmacokinetics (PK). 32-week interim results from the same Phase 3 study were previously presented at the 2022 American Academy of Ophthalmology (AAO) Annual Meeting in September 2022.2

The company noted that out of the total 449 patients with neovascular age-related macular degeneration (nAMD), 438 patients were first randomized 1:1 to receive either SB15 or AFL. At Week 32, patients were re-randomized to either continue SB15 or AFL, or switch from AFL to SB15 resulting in three treatment groups; continuing SB15 (SB15/SB15, n=219), continuing AFL (AFL/AFL, n=108), switching from AFL to SB15 (AFL/SB15, n=111). In total, 425 patients completed up to Week 56.

According to the company, key efficacy endpoints of the study were 1) change from baseline in best corrected visual acuity (BCVA), 2) change from baseline in central subfield thickness (CST), and 3) proportion of patients with intra/sub-retinal fluid. Up to Week 56, improvements in BCVA were comparable between three treatment groups. In the switching group (AFL/SB15), least square (LS) mean change from baseline CST was well maintained and comparable to the continuing group (AFL/AFL). Safety, immunogenicity, and PK profiles of SB15 were also comparable with those of AFL, and no treatment-induced or treatment-boosted anti-drug antibodies (ADA) developed in the switching group (AFL/SB15) after Week 32.

In addition to the 56-week results from the Phase 3 study, new analytical data on similarity between SB15 and AFL in terms of structural and physicochemical properties and biological functions was presented at the meeting. Based on the comprehensive analytical similarity assessment, SB15 showed high similarity to AFL with respect to structural, physicochemical, and biological properties.

“The presentations showcase our ongoing commitment in ophthalmology to bring more access to treatments for patients suffering from retinal vascular diseases,” Jin-Ah Jung, Medical Affairs Group Leader, Samsung Bioepis, said in a statement.

“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,” she added.

Samsung Bioepis and Biogen announced in November 2019 that they had entered into an exclusive commercialization agreement for two ophthalmology biosimilar candidates, ranibizumab and SB15 (aflibercept) in major markets around the world.

SB15, if approved, will strengthen the portfolio offerings of the two companies with two of the most widely prescribed anti-VEGF therapies, extending options for patients, prescribers while helping enable healthcare sustainability.