[의학신문·일간보사=안치영 기자] Samsung Bioepis (CEO Hanseung Koh) has finally obtained European marketing authorization for Lucentis biosimilar ‘BYOVIZTM, project name SB11, ingredient name ranibizumab’ from the European Commission (EC). said on the 23rd.
The final acquisition of this European marketing authorization is 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. was done in
As a result, Samsung Bioepis became the first company to obtain approval for the sale of a Lucentis biosimilar in the European market.
Lucentis is an ophthalmic disease treatment sold by Roche and Novartis, and has indications for macular degeneration and diabetic macular edema.
An official from Samsung Bioepis said, “We are delighted to be the first Lucentis biosimilar to be approved in the European market, and we will continue to strive to secure a product portfolio in various treatment fields for patients around the world.”
Meanwhile, Samsung Bioepis has a total of 10 types of blockbuster biosimilar products and pipelines, and 3 types of autoimmune disease treatment (SB2: Remicade biosimilar, SB4: Enbrel biosimilar, SB5: Humira biosimilar) Miller) and two anticancer drugs (SB3: Herceptin biosimilar, SB8: Avastin biosimilar) are on sale in Europe.