AdComm Shows Support for Celltrion’s Remicade Biosimilar

An FDA advisory committee last week gave Celltrion’s biosimilar candidate for Remicade a strong show of support, backing its approval for six different indications in a 21-3 vote.

The vote came as no surprise, as FDA briefing documents released ahead of the Arthritis Advisory Committee meeting recommended approval for CT-P13.

Much of the discussion hinged on whether the data presented was enough to justify CT-P13’s use for six conditions: rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis.