FDA Panel Recommends Approval of Infliximab Biosimilar

An FDA committee has recommended approval of CT-P13 (Remsima), a biosimilar version of infliximab, for rheumatoid arthritis and other conditions.

An independent advisory US Food and Drug Administration (FDA) committee has recommended approval of CT-P13 (Remsima), a biosimilar version of infliximab, for rheumatoid arthritis (RA) and ankylosing spondylitis (SA), psoriasis, Crohn’s disease and ulcerative colitis.

The Arthritis Advisory Committee’s February 9 recommendation was based largely on clinical trial data about RA and SA provided by Celltrion and Pfizer. Infliximab is marketed as Remicade by Johnson & Johnson, and is indicated for RA, AS, psoriatic arthritis, plaque psoriasis, adult and pediatric Crohn's disease and adult ulcerative colitis.

The committee concluded that “based on the totality of the evidence, CT-P13 should receive licensure as a biosimilar product to US-licensed Remicade for each of the indications for which US-licensed Remicade is currently licensed and CT-P13 is eligible for licensure.”[[{"type":"media","view_mode":"media_crop","fid":"45803","attributes":{"alt":"@Planar/Shutterstock.com","class":"media-image media-image-right","id":"media_crop_3730669361539","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"5264","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"font-size: 13.008px; line-height: 1.538em; float: right;","title":"@Planar/Shutterstock.com","typeof":"foaf:Image"}}]]

Johnson & Johnson objected to the extrapolation of trial data for RA and SA to inflammatory bowel disease (IBD), for which CT-P13 was not tested directly.

“We believe that the data to date, absent of direct comparisons of CT-P13 and REMICADE in patients with inflammatory bowel disease, leave uncertainty about whether differences in safety or efficacy may emerge for patients,” said Johnson & Johnson Chief Biotechnology Officer Jay Siegel, MD, immediately after the advisory committee meeting.

Remicade’s mechanism of action, pharmacokinetics, immunogenicity and safety profile are different in IBD than in RA and SA, he said.

In the meeting, Dr. Siegel remarked that CT-P13 “differs from REMICADE with regard to a number of chemical and physical attributes including glycosylation, glycation, and aggregation,” and that these differences could potentially impact drug function for patients with IBD.

Some advisory panel members “share our concerns regarding residual uncertainty” about CT-P13’s use with IBD, he said after the meeting. “We hope that FDA carefully considers both our detailed written testimony and the concerns voiced today on extrapolation.”

In Celltrion’s briefing document for the advisory committee, the company noted that concomitant immunosuppression with methotrexate, azathioprine and steroids might impact safety for patients with IBD, but concluded that it “is not anticipated that CT-P13 and Remicade will have different safety profiles in IBD patients under similar conditions of use as per approved label.”



Celltrion, CT-P13, FDA Advisory Committee Briefing 


, February 9, 2016 Arthritis Advisory Committee (AAC) Meeting, February 9, 2016, 



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