Samsung Bioepis Presents Positive Phase 3 Data on Aflibercept Candidate

New data from a phase 3 comparative efficacy study showed that SB15, an aflibercept biosimilar candidate, was as safe and effective as its reference product (Eylea) in patients with neovascular age-related macular degeneration (nAMD).

Neovascular age-related macular degeneration, also known as wet AMD, is a progressive retinal degenerative condition characterized by neovascularization of the choroid. The condition primarily affects elderly patients and can lead to gradual vision impairment.

The results were presented at EURETINA 2023, the annual meeting of the European Retina, Macula and Vitreous Society. The conference was held October 5-8 in Amsterdam, the Netherlands.

“We are pleased to present the switching data of SB15 from reference aflibercept that continues to demonstrate its comparable clinical efficacy and safety in treating patients with nAMD. We hope the study results also help allay concerns over safety and efficacy of biosimilars for their use in patients who were previously treated with reference product,” said HyeJin Kim, vice president and medical and lifecycle safety team leader at Samsung Bioepis.

The news comes after the European Medicines Agency granted Europe’s first aflibercept biosimilar (Yesafili; Biocon Biologics) marketing authorization.

Aflibercept is a vascular endothelial growth factor (VEGF) receptor inhibitor that is administered intravitreally. This medication class is used to treat macular edema and myopic choroidal neovascularization. When treating eye conditions, anti-VEGF medicines stop the abnormal blood vessels leaking, growing, and bleeding under the retina, which can cause intense pain and vision loss for patients.

The phase 3 study was a randomized, double-masked, parallel-group, multicenter assessment that included 449 participants. The patients were randomized 1:1 to receive 3 monthly injections (2 mg) of SB15 or the reference product, followed by treatment once every 8 weeks up to week 48.

The primary outcome was change from baseline in best corrected visual acuity (BVCA) at week 8. All end points were followed through week 56, and the safety and efficacy after transitioning products was comparable with that of prior to transitioning.

The mean BVCA between the switching and the reference product groups was 65.3 at week 32 (prior to switching) and 65.8 at week 56 (post switching) vs 65.2 at week 32 and 65.8 at week 56, respectively.

A post-hoc analysis was conducted to assess the biosimilarity of the 2 products. The analysis demonstrated that switching from Eylea to SB15 was safe and did not compromise patients’ clinical outcomes in nAMD.

Samsung Bioepis is developing SB15 in partnership with Biogen as part of a 2019 commercialization agreement. The partnership also includes SB11 (Byooviz), a ranibizumab biosimilar.

“This post hoc analysis provides valuable insights on the outcomes of switches from the reference biologic to SB15 and may help clinicians to make well-informed decisions on potential use of SB15 if approved”, said Mourad Farouk Rezk, MD, MBA, vice president and head of global medical and development, Biogen Biosimilars Unit.

Reference

Samsung Bioepis presents post-hoc analysis of phase 3 clinical trial for SB15, a proposed biosimilar to Eylea (aflibercept), at EURETINA 2023. News release. Samsung Bioepis. October 7, 2023. Accessed October 9, 2023. https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=352&currentPage=1