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A biosimilar of aflibercept (“SB15”) indicates comparability to the reference drug for neovascular AMD.

Results of a biosimilar agent (SB15) of aflibercept (Eylea) have reported comparable outcomes between the generic version and the reference drug (aflibercept) for naïve neovascular age macular degeneration (nAMD).  Data from a 32-week interim analysis in a phase 3 trial showed equivalent efficacy and comparable safety, pharmacokinetics and immunogenicity between SB15 and aflibercept in participants with treatment-naive nAMD. The study assessed best-corrected visual acuity (BCVA) outcomes and a similar safety profile to the reference drug (aflibercept, Regeneron) in patients using a randomised design.  In addition, the results provide evidence that there are no clinically meaningful differences in efficacy between SB15 and aflibercept.

According to a lead author of the data, Dr. SriniVas R. Sadda, MD, Department of Ophthalmology, Doheny Eye Institute, Pasadena, USA, outlined that aflibercept is an anti-VEGF agent harbouring the binding domains of VEGF receptors 1 and 2 and blocking all VEGF-A isoforms, VEGF-B and placental growth factor. The new SB15 is produced by recombinant DNA technology and, for regulatory approval, the similarity of the biosimilar to a reference product must be demonstrated based on structure, function, animal toxicity, human pharmacokinetics and pharmacodynamics, immunogenicity, safety, and effectiveness.

In their phase 3 study, the double-masked parallel group RCT was conducted in 10 countries from June 2020 to March 2022, recruiting 449 participants, half assigned to SB15 (n = 224) and half assigned to aflibercept (n = 225). Patients were randomized 1:1 to receive 2 mg of SB15 or aflibercept for every 4 weeks for the first 12 weeks (3 injections), followed by dosing every 8 weeks up to week 48.  The primary endpoint was the change in BCVA from baseline while other key endpoints were changes in central subfield thickness up to week 32, safety, pharmacokinetics and immunogenicity. Following the results, the least squares mean change in BCVA from baseline to week 8 in the SB15 group was equivalent to that in the aflibercept group (6.7 letters vs 6.6 letters, respectively; difference, 0.1 letters; 95% CI, −1.3 to 1.4). Comparable efficacy between treatment groups was maintained up to week 32 (least squares mean change from baseline in BCVA: SB15, 7.6 letters vs aflibercept, 6.5 letters; least squares mean change from baseline in central subfield thickness: SB15, −110.4 μm vs aflibercept, −115.7 μm). Furthermore, there were no clinically relevant differences observed in the incidence of treatment-emergent adverse events (TEAEs) (SB15, 107/224 [47.8%] vs aflibercept, 98/224 [43.8%]) and ocular TEAEs in the study eye (SB15, 41/224 [18.3%] vs aflibercept, 28/224 [12.5%]).  At the 2023 annual meeting of the American Society of Retina Specialists, Prof. Min Sagong, MD, PhD, a professor at Yeungnam University College of Medicine, in Daegu, South Korea, presented the data and commented that, “growing information indicates that switching from reference products to biosimilars is safe and effective, and that safety data were comparable without intraocular inflammation, retinal vasculitis, or vascular occlusion.