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Samsung’s Renflexis: Second US Biosimilar To Janssen’s Remicade, With A Few Firsts

 
• By Sue Sutter

Infliximab-abda gains FDA licensure without having faced an advisory committee review; under current case law, launch could come as early as mid-October.

Samsung Bioepis Co. Ltd.’s Renflexis (infliximab-abda), approved by FDA April 21, becomes the fifth biosimilar licensed in the US but still has its share of firsts.

It is the first biosimilar approved by FDA without an advisory committee review. It’s also the first time in the nascent US market that a single novel biologic (in this case, Janssen Biotech Inc

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