Australian Regulators Approve Samsung Bioepis’s Etanercept Biosimilar Brenzys

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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.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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