Post-hoc comparison: Ranibizumab and biosimilar showing similar efficacy in wet AMD

SB11 received FDA approval in 2021.

A ranibizumab biosimilar, SB11 (Samsung Bioepis Co.), demonstrated efficacy at 1 year of treatment that was similar to that observed with ranibizumab (Lucentis, Genentech) in a post-hoc analysis of a phase III trial comparison of the 2 drugs for treating neovascular age-related macular degeneration (AMD).

The baseline factors that predicted the efficacy of the 2 drugs were the baseline age, best-corrected visual acuity (BCVA), and central subfield thickness (CST), according to first study author Se Joon Woo, MD, PhD, from Seoul National University Bundang Hospital, Seoul, Korea.

SB11 received FDA approval in 2021 as a biosimilar of the reference drug in that SB11 has an identical primary amino acid sequence and very similar structural, physiochemical, and biological properties to ranibizumab, he explained.

Woo and colleagues conducted a randomized, double-masked, post-hoc analysis of phase III trial data to identify the factors pointing to efficacious outcomes in patients with neovascular AMD. A total of 705 patients were randomized to receive either SB11 or reference ranibizumab over the course of the study. The injections of the drugs were administered every 4 weeks.

The investigators reported that the baseline age, BCVA, and total lesion size were associated with the mean change from the baseline improvement in the BCVA at 1 years. The increments of the associated baseline factors reduced the mean improvement in the BCVA.

Likewise, the baseline age, BCVA, and CST were associated with the reduction in the mean change from the baseline CST at 1 year; the increments of the baseline age and CST showed an additional CST reduction and the baseline BCVA showed less reduction in the CST.

The investigators commented, “Overall, the subgroup analysis of change from baseline in the BCVA by different baseline factors showed comparable treatment effects within each subgroup between SB11 and reference ranibizumab across important baseline characteristics, which supported the robustness of the previously reported primary and secondary outcomes of SB11.”