Samsung Bioepis' Brenzys first Enbrel biosimilar approved in Canada

South Korea-based Samsung Bioepis says that its Brenzys – also known as SB4, a biosimilar to Amgen’s (Nasdaq: AMGN) Enbrel (etanercept), has received regulatory approval in Canada for the treatment of rheumatoid arthritis and ankylosing spondylitis. Brenzys will be commercialized in Canada by the local subsidiary of partner US pharma giant Merck & Co (NYSE: MRK).

“As evidenced in other markets, we believe Brenzys will help drive down healthcare costs and increase patient access to one of the most widely used autoimmune treatment options in Canada,” said Christopher Hansung Ko, president and chief executive of Samsung Bioepis, Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen (Nasdaq: BIIB); adding: “We remain committed to advancing one of the industry's largest biosimilar pipelines, so that more patients across Canada can access affordable, high-quality treatment.”

Prior to receiving approval in Canada, Samsung Bioepis’ SB4 etanercept biosimilar received regulatory approvals from Korea’s Ministry of Food and Drug Safety (MFDS) as Brenzys in September 2015, the European Commission (EC) as Benepali in January 2016 and Australia’s Therapeutic Goods Administration (TGA) as Brenzys in July 2016.