Samsung Bioepis said Monday that it has won approvals in major countries to conduct clinical trials for its new ophthalmology biosimilar candidate SB15, which references Regeneron Pharmaceuticals' age-related macular degeneration (AMD) drug Eylea, reported The Korea Bizwire.
Specifically, SB15 received authorisation from health authorities in eight countries, including Phase III trials in South Korea and the US, the company said.
The approvals come as Samsung Bioepis recently completed clinical trials of another AMD biosimilar candidate dubbed SB11 that references Novartis' Lucentis.
Lucentis was the first to reach the market for AMD with sales of some $3.7 billion globally last year. It has since been overtaken by Eylea, with $4 billion in US sales and another $2.1 billion in other markets in 2019.
However, Lucentis is due to lose protection in the US next year and in Europe in 2022, while Eylea's patents will end in 2020 and 2021 in the two markets, respectively.