Samsung Bioepis Nears European Approval for Ophthalmic Disease Treatment... First Biosimilar to Lucentis

[Asia Economy Reporter Seo So-jung] Samsung Bioepis (CEO Go Han-seung) announced on the 26th that it received a positive opinion for the marketing authorization of the ophthalmic disease treatment drug 'Lucentis' biosimilar (biopharmaceutical generic) 'Byooviz' (generic name ranibizumab) from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) on the 25th (local time).

This was achieved eight months after the EMA started reviewing the marketing authorization application (MAA) in October last year. Samsung Bioepis expects to obtain official marketing authorization after the final review by the European Commission (EC), which usually takes about 2 to 3 months.

Lucentis is an ophthalmic disease treatment drug marketed by Roche and Novartis, with indications including macular degeneration and diabetic macular edema. As of last year, its global sales reached approximately 4 trillion KRW.

If Samsung Bioepis's Byooviz receives final approval from the European Commission, it will become the first Lucentis biosimilar to be authorized for sale in the European market.

Additionally, Byooviz is the first ophthalmic disease treatment drug developed by Samsung Bioepis, and its marketing authorization review began in the U.S. market in November last year.

Go Han-seung, CEO of Samsung Bioepis, said, "We are pleased that Byooviz has received a positive opinion for marketing authorization as the first Lucentis biosimilar in the European market," adding, "We will continue to strive to secure a product portfolio in various therapeutic areas for patients worldwide."

Marketing of Byooviz in the European market is expected to be handled by the U.S.-based global biopharmaceutical company Biogen. In 2019, Samsung Bioepis signed a follow-up partnership agreement with Biogen, establishing new marketing partnerships for two ophthalmic disease treatments under development at the time (Lucentis biosimilar and Eylea biosimilar) in major markets including the U.S. and Europe.

Through this, Samsung Bioepis plans to strengthen its marketing collaboration with Biogen in the ophthalmic disease treatment area, alongside their existing cooperation on three autoimmune disease treatments in Europe, aiming to secure a competitive edge in the global biosimilar market.

This content was produced with the assistance of AI translation services.