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FDAnews Drug Daily Bulletin

Samsung Bioepis, Merck Launch Remicade Biosimilar Early, Following SCOTUS Decision

July 28, 2017

Samsung Bioepis and Merck announced the U.S. launch of Renflexis (infliximab-abda), a biosimilar of Janssen’s Remicade (infliximab).

Earlier this year, Janssen filed a lawsuit in New Jersey federal court, hoping to delay Renflexis from entering the market. At the time, Samsung Bioepis had bet on an upcoming Supreme Court decision going its way.

Janssen claimed Samsung Bioepis failed to provide its Renflexis application, filed with the FDA last year, and the relevant manufacturing information required by law, so that Janssen could assess any infringements on its patents.

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