Samsung Biologics Co. said Wednesday its affiliate Samsung Bioepis Co. won a nod from South Korea‘s drug agency to sell its biosimilar dubbed SB5.
Through the approval granted by the Ministry of Food and Drug Safety, Samsung Biologics said in a regulatory filing that the biosimilar is ready for sale in the country.
Ko Han-sung, CEO of Samsung Bioepis
The SB5 is a biosimilar of Humira released by U.S.-based AbbVie Inc., used for the treatment of various diseases including Crohn’s disease and rheumatoid arthritis.
A biosimilar is a copy of a medicine developed after the patents for the original drug have expired.
Samsung Biologics said the detailed launch schedule of the biosimilar will be fixed later to reflect the patent expiration date of Humira.
Samsung Bioepis is a joint venture between Samsung Biologics and U.S. Biogen Inc.