Samsung Bioepis Obtains Europe's First Marketing Authorization for 'Lucentis' Biosimilar
[Asia Economy Reporter Chunhee Lee] Samsung Bioepis's Lucentis biosimilar (replicated biopharmaceutical) 'Byooviztm' has obtained final approval for sale in Europe.
On the 23rd, Samsung Bioepis announced that it had obtained final approval for the sale of its Lucentis biosimilar Byooviz (SB11, generic name 'ranibizumab') in Europe. This came about two months after receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) on June 24.
This approval marks the first Lucentis biosimilar sales authorization in Europe. Lucentis is an ophthalmic disease treatment marketed by Roche and Novartis. It is indicated for macular degeneration, diabetic macular edema, and other conditions. As of last year, its global sales reached approximately 4 trillion KRW. The patent expired in the U.S. market in June last year, and the European patent is set to expire in July next year.
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A Samsung Bioepis official said, "We are pleased to be the first to receive approval for a Lucentis biosimilar in the European market," adding, "We will continue to strive to secure a product portfolio in various therapeutic areas for patients worldwide."
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