미분류

Samsung Bioepis’ biosimilar approved for sale in Canada

By 황유미
  • Published : Sept 13, 2016 - 14:17
  • Updated : Sept 13, 2016 - 16:55
[THE INVESTOR] Samsung Bioepis announced on Sept. 12 that its biosimilar Brenzys has been granted approval for sale in Canada.

Its reference drug is Enbrel (etanercept), an autoimmune disease treatment developed by Amgen and sold by Pfizer that has raked in 10 trillion won (US$9.02 billion) worldwide.

The knockoff version has won approval from South Korean Ministry of Food and Drug Safety in September 2015; in Europe in January under trade name Benepali; and in Australia in July.





It will be sold by Merck Canada as a treatment for rheumatoid arthritis and ankylosing spondylitis, an arthritis that primarily affects the spine.

The biopharmaceutical unit of Samsung reported that Brenzys had similar efficacy and safety to the original medicine in a phase 3 clinical trial carried out in 10 countries with 596 patients with rheumatoid arthritis.

By Hwang You-mee (glamazon@heraldcorp.com)