Australian Regulators Approve Samsung Bioepis’s Etanercept Biosimilar Brenzys

On July 22, 2016, Australia’s Therapeutic Goods Administration approved Samsung Bioepis’s biosimilar of Amgen’s Enbrel (etanercept), which is approved for treatment of rheumatoid arthritis.  Samsung Bioepis’s product, called Brenzys, will be available as a pre-filled auto-injector and sold in Australia by Merck Sharpe & Dohme, Merck & Co.’s international subsidiary.

Samsung Bioepis already markets its etanercept biosimilar in Europe and South Korea.