After getting the nod in Europe, Samsung Bioepis has gained U.S. marketing approval for a biosimilar referencing Lucentis to enter the 4 trillion won ($3.38 billion) worth global age-related macular degeneration (AMD) market.

Samsung Bioepis recently signed a license agreement with Genentech, the developer of the original drug Lucentis, signaling an accelerated market release of the biosimilar.

On Thursday, the Korean biopharmaceutical company said that it obtained FDA approval to market Byooviz (ingredient: ranibizumab, project name: SB11) in the U.S.

With the latest approval, Samsung Bioepis sells the first biosimilar of Lucentis in the U.S. market. In August, the European Commission authorized the marketing of Byooviz.

Industry watchers said Samsung Bioepis might have agreed with Genentech on when to release Byooviz in the U.S. and Europe as the two signed the license agreement after Europe’s marketing approval in August.

Such speculation emerged because Samsung Bioepis suddenly disclosed the information about the license agreement with Genentech. The Korean company used to be reluctant to comment on the original drug developer’s patent strategy to delay the market entry of the biosimilar.

Before Samsung Bioepis started selling Herceptin biosimilar Ontruzant (trastuzumab) in the U.S. in 2019, it ended the patent dispute with the developer of the original drug, Genentech, and entered a license agreement.

Samsung Bioepis refused to comment on the market release of Byooviz.

However, the company said it can sell the biosimilar as of June 2022 before the expiration of Genentech’s Supplementary Protection Certificate (SPC). In other regions, it can market the produce after Genentech’s SPC expires.

Samsung Bioepis said it would sell Byooviz through a marketing partnership with Biogen in major markets such as the U.S. and Europe.

Sold by Roche and Novartis, Lucentis is a treatment for ophthalmology diseases such as macular degeneration. The global sales of Lucentis reached approximately 4 trillion won, and the U.S. sales marked about 1.8 trillion won (1.4 billion Swiss francs).

“We’re pleased to win approval for the first ophthalmic disease biosimilar in the U.S., the world’s largest pharmaceutical market. We will continue to make efforts to provide opportunities to prescribe quality biosimilars for patients in various fields,” said Ko Han-sung, CEO of Samsung Bioepis.