The FDA Arthritis Advisory Committee has recommended the approval of CT-P13 (Remsima), a biosimilar version of the TNF inhibitor infliximab (Remicade), for ankylosing spondylitis, rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis.
The committee’s recommendation for approval was “based on the totality of the evidence presented” by South Korean drug manufacturer Celltrion, including safety and efficacy clinical trial data on ankylosing spondylitis (AS) and rheumatoid arthritis (RA).
“The Advisory Committee concluded that the data submitted by Celltrion demonstrates CT-P13 is highly similar to U.S.-licensed Remicade, notwithstanding minor differences in clinically inactive components. Further, the Committee noted that there were no clinically meaningful differences between CT-P13 and U.S.-licensed Remicade in terms of the safety, purity, and potency of the product in the studied indications of rheumatoid arthritis and ankylosing spondylitis.”
The committee voted to extrapolate and apply the AS and RA trial data to other conditions for which infliximab is currently approved, thereby also recommending approval for psoriasis, Crohn’s disease, and ulcerative colitis. There were concerns voiced by some Committee members on extending the recommendation for approval to Crohn’s disease and ulcerative colitis specifically without direct clinical trial evidence on the safety and efficacy of the biosimilar for those conditions. Johnson and Johnson, the manufacturer of infliximab, also objected to the vote to approve CT-P13 for Crohn’s and ulcerative colitis for those same reasons.
The committee recommendation does not guarantee FDA approval of CT-P13; however, if approved the medication would be the first biosimilar available in the US for a form of Spondyloarthritis, and the first biosimilar monoclonal antibody (mAb) to be licensed in the US.
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