Samsung Bioepis Initiates EU Marketing Authorization for SB11

[Asia Economy Reporter Cho Hyun-ui] Samsung Bioepis announced on the 4th that the European Medicines Agency (EMA) has started the review of the Marketing Authorization Application (MAA) for the ophthalmic disease treatment 'SB11' on the 1st (local time).

SB11 is a biosimilar (biopharmaceutical copy) of 'Lucentis,' an ophthalmic disease treatment for macular degeneration and diabetic macular edema sold by Swiss multinational pharmaceutical companies Roche and Novartis.

Regarding the start of the EMA's review of the marketing authorization application, the company explained, "It means that the EMA has completed the preliminary review of the marketing authorization application we submitted last month and is now proceeding with the formal sales authorization review."

Samsung Bioepis will be the first to undergo the sales authorization process for the Lucentis biosimilar in Europe. The substance patent for Lucentis, which had global sales of approximately 4.6 trillion KRW last year, is scheduled to expire in Europe in January 2022.

A Samsung Bioepis official stated, "We will once again demonstrate our research and development capabilities during the European sales authorization review process for SB11 and strive to successfully introduce the first ophthalmic disease treatment to patients."

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