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BioWorld - Friday, February 13, 2026
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Home » Samsung Bioepis’ Byooviz wins EMA approval
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Samsung Bioepis’ Byooviz wins EMA approval

Aug. 31, 2021
By Angie Ling
Samsung Bioepis Co. Ltd. has emerged as the first company to obtain marketing authorization from the EMA for a biosimilar of Lucentis (ranibizumab), a significant development for the Korean biosimilar specialist. The approval comes less than two months after the company received a positive opinion from the EMA’s CHMP for Byooviz (ranibizumab), formerly called SB-11.
BioWorld Asia Drugs Regulatory Ocular Biosimilar Asia-Pacific Europe EMA

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