FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

AdComm Sets Meeting to Discuss Celltrion’s Remicade Biosimilar Candidate

Feb. 1, 2016
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The FDA’s Arthritis Advisory Committee will meet Feb. 9 to discuss Celltrion’s biosimilar for immunosuppressant Remicade.

Korea’s Celltrion is seeking nine indications for the biosimilar, most of which mirror Remicade’s approved indications. Industry will be closely watching whether the agency will allow extrapolation to the other indications.

Celltrion and partner Hospira market the biosimilar as Remsima in other global markets. An advisory committee meeting for Remsima originally was scheduled for March 17, 2015, but it was postponed because the FDA requested additional information.