INCHEON, Korea – October 7, 2023 – Samsung Bioepis Co., Ltd. today announced that it presented a post-hoc analysis of the Phase 3 clinical study results for SB15, a proposed biosimilar to Eyleaⁱ (aflibercept), at EURETINA 2023 being held from October 5 to 8 in Amsterdam, the Netherlands. 

In this Phase 3, randomized, double-masked, parallel-group multicenter studyⁱⁱ , a total of 449 study participants were randomized 1:1 to receive 3 monthly intravitreal injections of either 2 mg SB15 or reference aflibercept (AFL) initially, followed by treatment once every 8 weeks up to week 48. The aim of the post-hoc analysis was to find out biosimilarity between SB15 and reference aflibercept. 

This post-hoc analysis demonstrated that switching to SB15 from AFL maintained comparable clinical efficacy and safety in treating patients with neovascular age-related macular degeneration (nAMD), confirming biosimilarity between these agents before and after switching.

The primary endpoint was change from baseline in best corrected visual acuity (BCVA) at week 8; all endpoints were followed through week 56. The efficacy and safety after switching were compared with that of prior to switching. A post-hoc analysis was conducted on efficacy endpoints including change in BCVA and central subfield thickness (CST), using data measured at time of re-randomization at week 32 prior to injection as the new baseline to compare clinical biosimilarity between SB15 and AFL post-switching (AFL/SB15 group vs AFL/AFL group).

“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, Medical and Lifecycle Safety Team Leader at Samsung Bioepis. “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, SB11/BYOOVIZ™ (ranibizumab) and SB15 (aflibercept) in major markets around the world.  

“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, Head of Global Medical and Development, Biogen Biosimilars Unit.

SB15 switching data aside, Samsung Bioepis also showcased two other presentations at EURETINA and the details are as below: 

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A total of 449 study participants were randomized 1:1 to receive 3 monthly 0.05 mL intravitreal injections of either 2 mg SB15 or AFL initially, followed by treatment once every 8 weeks up to week 48. At week 32, a total of 438 participants were re-randomized, resulting in 219 continuing SB15, 108 continuing AFL (AFL/AFL), and 111 switched from AFL to SB15 (AFL/SB15). 425 (97.0%) re-randomized participants completed the study up to week 56. The new baseline (W32; prior to re-randomization) characteristics were comparable between the continued (AFL/AFL) group and the switched (AFL/SB15) group. The efficacy was well-maintained post-switching as the mean BCVA letter score (~Snellen equivalent) was 65.3 (20/50) at Week 32 (pre-switching) and 65.8 (20/50) at Week 56 (post-switching) for the AFL/SB15 group compared with 65.2 (20/50) at Week 32 and 65.8 (20/50) at Week 56 within AFL/AFL group. Also, there was no difference in efficacy between the two groups post-switching as the least square (LS) mean for change from W32 in BCVA at week 56 for AFL/AFL was 0.0 letters and 0.2 letters for AFL/SB15 (difference: 0.3 [95% CI: -1.2, 1.8] letters). The LS mean for change from W32 in CST at week 56 for AFL/AFL was -13 μm and for AFL/SB15 was -9 μm (difference: 4 [95% CI: -7, 14] μm). There were no additional safety signals identified and the immunogenicity profile was also similar after switching.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, endocrinology, and gastroenterology. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn.

Jane Chung, ejane.chung@samsung.com

Anna Nayun Kim, nayun86.kim@samsung.com

ⁱ Eylea is a trademark of Regeneron.

ⁱⁱ Srinivas R Sadda, Se Joon Woo, et al. Pre-to-Post Switching Efficacy and Safety Assessments of SB15 (Proposed Aflibercept Biosimilar) in Neovascular Age-Related Macular Degeneration: Findings from a Post-hoc Analysis of a Phase III Clinical Trial. Presentation Presented at EURETINA 2023

ⁱⁱⁱ The same study results were first presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting (Apr 23-27, 2023).

^iv The same analysis results were first presented at the American Academy of Ophthalmology (AAO) 2022 Annual Meeting (Sep 30-Oct 3, 2022) under the title “Correlation Analysis between Immunogenicity and Clinical Outcomes of an Approved Ranibizumab Biosimilar, Byooviz™ (SB11)” (Neil M Bressler, Se Joon Woo et al).