An aflibercept biosimilar, SB15, shows no clinically significant differences from aflibercept for the treatment of neovascular AMD (nAMD) in either outcomes or adverse events according to a phase 3 trial.
Study design
This was a randomized double-masked, international, multicenter phase 3 trial comparing the efficacy and safety of an aflibercept biosimilar, SB15 (n = 224), vs aflibercept (n = 225) for nAMD. Patients received treatment every 4 weeks for the first 12 weeks, then every 8 weeks up to week 48, with final assessment at week 56. The primary end point was the change in BCVA from baseline to week 8, with equivalence margins predefined at −3 letters to 3 letters.
Outcomes
There were no significant differences between the SB15 group and the aflibercept group in letters gained from baseline to 8 weeks (6.7 letters vs 6.6 letters, respectively) or from baseline to 32 weeks (7.6 letters vs 6.5 letters, respectively). At 32 weeks, both groups also showed similar improvements in central subfield thickness (−110.4 μm for SB15 vs −115.7 μm for aflibercept). Additionally, the SB15 and aflibercept groups showed similar incidences of treatment-emergent adverse events (TEAEs) (48% vs 44%, respectively) and ocular TEAEs (18% vs 13%, respectively) in the study eye and no significant between-groups differences in the incidence of intraocular inflammation. Hypertension was the most common nonocular TEAE (2.7% for SB15 vs 0.4% for aflibercept).
Limitations
The primary endpoint was only 8 weeks of treatment, and there is limited follow-up available with final follow-up occurring at 56 weeks.
Clinical significance
Biosimilars continue to be studied as alternatives to commonly used medications for retinal diseases for their potential benefit in expanding patient treatment options. Although this study had a relatively short follow-up period, similar efficacy and safety profiles were seen between aflibercept and its SB15 biosimilar. Further longer-term studies and real-world experience are needed to continue to assess this and other biosimilars.
Financial Disclosures: Dr. Ajay Kuriyan discloses financial relationships with Adverum, Annexon, National Eye Institute (Grant Support); Alimera Sciences, Allergan, Bausch + Lomb, EyePoint Pharmaceuticals, Novartis, Alcon Pharmaceuticals (Consultant/Advisor); Optos (Lecture Fees/Speakers Bureau); Lumata Health, Recens Medical (Consultant/Advisor, Private Equity/Stock Holder); Spark Therapeutics (Consultant/Advisor, Lecture Fees/Speakers Bureau); Genentech (Consultant/Advisor, Lecture Fees/Speakers Bureau, Grant Support).