Immunogenicity profiles similar in neovascular AMD for ranibizumab and biosimilar drug

An approved biosimilar drug, Byooviz (SB11, Samsung Bioepis) demonstrated low immunogenicity that was similar to that of ranibizumab (Lucentis, Genentech) after 1 year of treatment in patients with neovascular age-related macular degeneration (AMD), according to Neil Bressler, MD, and associates. He is from the Johns Hopkins University School of Medicine, Baltimore.

This post-hoc analysis was performed to evaluate immunogenicity over the long term. Bressler explained that while anti-vascular endothelial growth factor drugs are used to manage neovascular AMD, they may induce anti-drug antibodies.

“This is concerning because anti-drug antibodies can neutralize ranibizumab, which would limit the drug’s effectiveness by affecting the drug concentration and eliciting an immune response,” he said.

He and colleagues conducted a post-hoc analysis of data from a phase III study that included 705 patients with neovascular AMD who were randomized to either monthly intravitreal 0.5-mg injections of ranibizumab or SBII for up to 48 weeks. The efficacy data were analyzed based on the patients’ antidrug antibody status through week 52, he explained.

Antidrug antibody response

The primary finding at week 52 was that the cumulative incidence of overall antidrug antibodies was low, i.e., an overall 4.6% of 691 patients with immunogenicity results, and similar in both study groups, 4.2% and 5.5% in patients receiving SBII and ranibizumab, respectively.

The investigators also reported that the change in the best-correct vision compared with baseline and the change in the central subfield thickness at 1 year were not associated with the antidrug antibody status for the 2 treatments in this patient population.

“The immunogenicity profile was low and did not appear to differ between SB11 and ranibizumab. Immunogenicity in this trial did not seem to be associated with efficacy outcomes,” Bressler concluded.