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Merck Signs $117 Million Deal with U.S. Govt on Samsung Bioepis Biosimilar

Penelitian - Merck & Co. has won a $117 million contract to supply the biosimilar Renflexis, developed by Samsung Bioepis Co., to the U.S. Department of Veterans Affairs, industry sources said Sunday.

Merck, known as MSD outside the U.S. and Canada, said last week that Renflexis was awarded a national contract. Renflexis, a biosimilar of Janssen Biotech, Inc.'s blockbuster immunology medicine Remicade, won approval from the U.S. Food and Drug Administration in April 2017.

Penelitian Merck Signs $117 Million Deal with U.S. Govt on Samsung Bioepis Biosimilar

"We are pleased that VA has chosen to expand access to an important treatment option such as RENFLEXIS for our Veterans who have nobly served this country," said Patrick Magri, senior vice president of U.S. hospital & specialty business unit at Merck.

Under a 2013 deal, Merck is responsible for commercializing multiple biosimilar candidates in certain partnered territories, while Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and regulatory registration.

In 2015, South Korea's Ministry of Food and Drug Safety approved Renflexis for treatment for rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and plaque psoriasis.

Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen Inc. Samsung BioLogics is a biopharmaceutical unit of South Korea's top conglomerate Samsung Group.

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