Samsung Bioepis said SB15, a biosimilar candidate referencing Eylea (ingredient: aflibercept), demonstrated similar efficacy, safety, immunogenicity, and pharmacokinetics (PK) to the original drug in a phase 3 clinical trial. 

During the 2023 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO 2023), the Korean biosimilar manufacturer presented one-year results of the phase 3 study.

Eylea is a blockbuster ophthalmic drug developed by Regeneron and treats wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). Eylea is expected to reach substance patent expiration in the U.S. in June 2023 and in Europe in May 2025.

At the meeting, researchers presented 56-week results from the phase 3 clinical study between SB15 and reference aflibercept in terms of efficacy, safety, immunogenicity, and pharmacokinetics (PK).

The company had previously presented the 32-week interim results of the same phase 3 study during the 2022 American Academy of Ophthalmology (AAO) Annual Meeting in September 2022.

Out of the total 449 patients with neovascular age-related macular degeneration (nAMD), 438 patients were first randomized in exactly half to receive either SB15 or Eyela.

At Week 32, patients were re-randomized to either continue SB15 or Eyela, or switch from Eyela to SB15, resulting in three treatment groups -- continuing SB15 (219 patients), continuing Eyela (108 patients), switching from Eyela to SB15 (111 patients).

At week 56, the company had completed the re-randomizing process.

Key efficacy endpoints of the study changed from baseline in best corrected visual acuity (BCVA) and baseline in central subfield thickness (CST), and proportion of patients with intra- or sub-retinal fluid.

Up to Week 56, improvements in BCVA were comparable between the three treatment groups.

In the group that switched from Eyela to SB15, least square (LS) mean change from baseline CST was well maintained and comparable to the group that continued to receive Eyela only.

Safety, immunogenicity, and PK profiles of SB15 were also comparable with those of Eyela, and no treatment-induced or treatment-boosted anti-drug antibodies (ADA) developed in the group that switched from Eyela to SB15 after week 32.

In addition to the 56-week results from the phase 3 study, new analytical data on the similarity between SB15 and Eyela in terms of structural and physicochemical properties and biological functions were presented at the meeting.

Based on the comprehensive analytical similarity assessment, SB15 showed high similarity to Eyela 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," Samsung Bioepis Medical Affairs Group Leader Jung Jin-ah said. “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.”