BRIEF—Further data shows biosimilarity between Lucentis and Samsung Bioepis copy

9 September 2021

Samsung Bioepis has announced results from a post-hoc and subgroup analysis of a Phase III study of Byooviz (ranibizumab) in neovascular age-related macular degeneration (nAMD).

Byooviz is the Korean company’s biosimilar of Roche and Novartis’ Lucentis. It was approved by the European Commission in August 2021.

Donghoon Shin, vice president and medical and lifecycle safety team leader at Samsung Bioepis, explained: “This post-hoc analysis of a Phase III study presented at EURETINA 2021 demonstrates important baseline factors that determine efficacy outcomes of nAMD treatment. Additional subgroup analysis showed that there was no difference between Byooviz and the reference ranibizumab in week 52 visual outcomes in many different subgroups, and this result further supports biosimilarity between Byooviz and reference ranibizumab.

“This goes to show that Byooviz is an effective and a valuable treatment option for nAMD patients worldwide.”

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