Samsung Bioepis' Ophthalmology Biosimilar Candidate Receives Clinical Approvals in 8 Markets - (The Korea Bizwire via NewsPoints Desk)

  • 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.

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