No unexpected adverse events for ranibizumab biosimilars in initial clinical experience
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SEATTLE — Initial experience with two ranibizumab biosimilars showed no unexpected adverse events, according to a study presented at the American Society of Retina Specialists annual meeting.
Carl C. Awh, MD, FASRS, said there are now two FDA-approved ranibizumab biosimilars, Byooviz (ranibizumab-nuna, Samsung Bioepis/Biogen) and Cimerli (ranibizumab-eqrn, Coherus BioSciences), after the patent for Lucentis (ranibizumab, Genentech) expired in 2020. However, the biosimilars were supported by relatively small clinical studies.
“Are there any unanticipated clinical outcomes associated with these new ranibizumab biosimilars?” he said. “The answer comes through clinical experience.”
Awh and colleagues conducted a retrospective study comprising 5,085 eyes of 3,964 patients with at least 28 days of follow-up after their first injection with a ranibizumab biosimilar. They looked at new findings of anterior chamber or vitreous cells, endophthalmitis, uveitis, vasculitis or other adverse events.
In the study, there were 5,049 injections of Byooviz and 8,410 injections of Cimerli.
There was no statistically significant difference in visual acuity at 1, 2 and 3 months after injection.
Nine cases had minimal anterior chamber or vitreous cells without vision loss; there were no cases of retinal vasculitis or cases of inflammation presumed secondary to a drug reaction.
Out of more than 13,000 injections, there were three cases of bacterial endophthalmitis. Awh said the three cases occurred during the first 900 injections, with none occurring in the last 12,500 injections.
“Our initial experience with ranibizumab biosimilar agents revealed no unexpected adverse outcomes,” Awh said. “The clinical efficacy of the biosimilar agents seems equivalent to Lucentis. We will continue to evaluate and report.”
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Awh CC, et al. Efficacy and safety of biosimilar ranibizumab-nuna and ranibizumab-eqrn in clinical use by a consortium of retina specialists. Presented at: American Society of Retina Specialists annual meeting; July 28-Aug. 1, 2023; Seattle.
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