Samsung Bioepis applies for FDA approval on SB5 biosimilar

SEOUL, Sept. 27 (Yonhap) -- South Korean pharmaceutical firm Samsung Bioepis Co. said Thursday it has applied to win approval for sales of the SB5 biosimilar with the U.S. drug authority. Samsung Bioepis said the U.S. Food and Drug Administration started review on the application, which will pave the way for the company to sell the product in the key North American market. The SB5 is a biosimilar of Humira released by U.S.-based AbbVie Inc. and used for the treatment of various diseases, including Crohn's disease and rheumatoid arthritis. Samsung Bioepis got a nod in August last year to sell the SB5 in Europe, with the official launch slated to begin in October in cooperation with Biogen. Samsung Bioepis was established in 2012 in a joint venture between Samsung BioLogics Co. and Biogen. Samsung Bioepis and AbbVie agreed on a patent in April, which allows the South Korean company to sell the SB5 in Europe starting in October this year. Sales in the United States will be allowed starting in June 2023. colin@yna.co.kr (END)