Samsung Bioepis gets nod for sale of ophthalmology biosimilar drug in Europe

Samsung Bioepis gets nod for sale of ophthalmology biosimilar drug in Europe

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This image, taken on Monday, shows Samsung Bioepis Co.'s headquarters. (Samsung Bioepis Co.)

This image, taken on Monday, shows Samsung Bioepis Co.’s headquarters. (Samsung Bioepis Co.)

South Korean biopharmaceutical firm Samsung Bioepis Co. said Monday it has won approval from European authorities for the sale of its ophthalmology biosimilar, Byooviz.

The European Commission granted the marketing authorization on ranibizumab biosimilar, previously known as SB11, which references Swiss pharmaceutical giant Novartis’ blockbuster medication Lucentis.

It is the first biosimilar referencing Lucentis to be commercialized in the European Union. The Novartis product registered $1.93 billion in sales for 2020.

Lucentis is a medication for ophthalmic disease and has indications for treating macular degeneration, a common eye disorder among people over 50.

Samsung Bioepis and its marketing partner Biogen Inc. are also seeking to commercialize an aflibercept biosimilar candidate, known as SB15, which is currently in phase three clinical trial evaluation.

Samsung Bioepis, established in 2012, is a joint venture between Samsung Biologics and Biogen. Samsung BioLogics is a biopharmaceutical unit of South Korea’s top conglomerate, Samsung Group.

Samsung Bioepis currently has 10 products and pipelines of blockbuster drugs in its portfolio. The company is selling three biosimilars for autoimmune diseases and two anticancer biosimilar therapies in Europe. (Yonhap)



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Robert Swift

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