FDA backs Remicade biosimilar, Remsima in the United States

February 8, 2016 10:01 AM

U.S. Food and Drug Administration released favorable report ahead of a meeting this Tuesday of an independent medical advisory panel to the agency.

The reports states that, “Celltrion provided extensive analytical and clinical pharmacology bridging data to scientifically justify the relevance of data obtained using EU-approved Remicade to a demonstration of biosimilarity of CT-P13 to the US-licensed reference product.”

The conclusion of the comparison of the structural and functional properties of the clinical and commercial product lots of CT-P13 and US-licensed Remicade was that they were highly similar, notwithstanding minor differences in clinically inactive components.

FDA said, it cited some “minor differences in clinically inactive components, and that there are no clinically meaningful differences between CT-P13 and US-licensed Remicade in terms of the safety, purity, and potency of the product.”

Remsima, which is approved in EU and several other countries will be the second approved biosimilar in the United States. Zarzio, the biosimilar of Amgen’s Neupogen was approved last year in the US.

FDA briefing document can be reached from here.

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