Samsung Bioepis Obtains US Approval for Lucentis Biosimilar

First Approval for Lucentis Biosimilar Sales in the US

Samsung Bioepis New Headquarters Exterior (Photo by Samsung Bioepis)

[Asia Economy Reporter Kim Ji-hee] Samsung Bioepis announced on the 22nd that it has obtained sales approval from the U.S. Food and Drug Administration (FDA) for BYOOVIZTM, a biosimilar of Lucentis (active ingredient ranibizumab).

The approval came about 10 months after the completion of the pre-review of the Biologics License Application (BLA) last November and the commencement of the formal document review process.

Following the European Commission's (EC) approval of BYOOVIZ sales in August, Samsung Bioepis has now secured the first sales approval for a Lucentis biosimilar product in the U.S. market. Lucentis is an ophthalmic treatment for diseases such as macular degeneration, marketed by Roche and Novartis. Its global sales reached approximately 4 trillion KRW last year, with U.S. sales accounting for about 1.8 trillion KRW.

Under the licensing agreement with Genentech, Samsung Bioepis can sell the product in the U.S. starting June 2022, before the expiration of Genentech's Supplementary Protection Certificate (SPC). In other regions, sales can begin after the SPC expires. In major markets such as the U.S. and Europe, BYOOVIZ will be marketed through a partnership with Biogen.

With this sales approval for BYOOVIZ, Samsung Bioepis can expand its business portfolio to include ophthalmic treatments, following its existing three autoimmune disease treatments (SB2, SB4, SB5) and two oncology drugs (SB3, SB8).

Go Han-seung, CEO of Samsung Bioepis, said, "We are pleased to receive sales approval for our first ophthalmic treatment in the world's largest pharmaceutical market, the U.S. We will continue to strive to provide patients with opportunities to access high-quality biopharmaceuticals across various fields."