Article

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

Author(s):

Baseline age, best-corrected visual acuity, and central subfield thickness play role in predicting the efficacy of both drugs.

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.”

Newsletter

Don’t miss out—get Ophthalmology Times updates on the latest clinical advancements and expert interviews, straight to your inbox.

Related Videos
(Image credit: Ophthalmology Times) CCOI's new CEO Malvina Eydelman, MD, outlines her mission and vision for the organization
(Image credit: Ophthalmology Times) ASCRS 2025: Deb Ristvedt, DO, on medications, lasers, and lifestyle in glaucoma management
(Image credit: Ophthalmology Times) ASCRS 2025: Mark Lobanoff, MD, on making the move to office-based surgery
(Image credit: Ophthalmology Times) NeuroOp Guru: When eye findings should prompt neuroimaging in suspected neuro-Behcet disease
At the Association for Research in Vision and Ophthalmology (ARVO) meeting, Katherine Talcott, MD, a retina specialist at Cleveland Clinic, shared her findings on EYP-1901 (EyePoint Pharmaceuticals) in the phase 2 DAVIO study.
Dr. Jogin Desai, founder of Eyestem Research, discusses his research at the Association for Research in Vision and Ophthalmology.
(Image credit: Ophthalmology Times) ASCRS 2025: Michael Rivers, MD, shares his takeaways as a panelist at the inaugural SightLine event
(Image credit: Ophthalmology Times) ASCRS 2025: Karl Stonecipher, MD, on LASIK outcomes using an aspheric excimer laser for high myopia
© 2025 MJH Life Sciences

All rights reserved.