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Samsung Bioepis Enters Japanese Market With Autoimmune Biosimilar

Samsung Bioepis Enters Japanese Market With Autoimmune Biosimilar

SEOUL, Dec. 23 (Korea Bizwire) — Samsung Bioepis Co., a biosimilar drug developer under Samsung Group, said Tuesday it has received approval to sell its biosimilar treatment for autoimmune disease in Japan. The biosimilar, which references U.S. biotechnology firm Johnson & Johnson’s original drug Stelara, was approved under the product name Ustekinumab BS Subcutaneous Injection [...]

Samsung Bioepis Wins Approval to Sell Biosimilar in South Korea

Samsung Bioepis Wins Approval to Sell Biosimilar in South Korea

SEOUL, Sept. 20 (Korea Bizwire) – 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. The SB5 is a biosimilar of Humira released by U.S.-based AbbVie Inc., used for the treatment of various diseases including Crohn’s [...]