FDA Releases Briefing Report on Infliximab Biosimilar

CT-P13 is highly similar to infliximab (Remicade), with no noted clinical differences in safety, purity, or potency.

The Arthritis Advisory Committee of the US Food and Drug Administration (FDA) has released a briefing document stating that CT-P13 is highly similar to infliximab (Remicade), with no noted clinical differences in safety, purity, or potency.1  CT-P13 is an immunoglobulin G (IgG)-1 chimeric human-murine monoclonal antibody,  developed as a biosimilar to infliximab, an anti-tumor necrosis factor-alpha (anti-TNF-α) monoclonal antibody.2    The clinical trials of CT-P13 were the first to compare a biosimilar to a biologic agent for the treatment of rheumatic disease.3

A biosimilar is defined by the World Health Organization as a “biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product”.CT-P13 has the same amino acid sequence as infliximab and is produced in the same type of cell line. It exhibits similar in vitro and in vivo pharmacodynamics, binding specificities, and affinities as infliximab.1

CT-P13 has shown equivalent clinical efficacy to infliximab in the PLANETRA (Programme evaluating the autoimmune disease investigational drug CT-P13 in RA patients) trial, a phase 3 trial in patients with rheumatoid arthritis.

“In considering the totality of the evidence, the data submitted by the applicant show that CT-P13 is highly similar to US-licensed Remicade,” the FDA briefing document states. “The applicant has also provided an extensive data package to address the scientific considerations for extrapolation of data to support biosimilarity to other conditions of use suggesting that CT-P13 should receive licensure for each of the seven indications for which US-licensed Remicade is currently licensed and for which CT-P13 is eligible for licensure.”

In the United States, infliximab is currently licensed for 7 indications: rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, ulcerative colitis, pediatric ulcerative colitis, and Crohn disease. 


1.   FDA Briefing Document Arthritis Advisory Committee Meeting. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM484859.pdf. Accessed February 8, 2016.

2.   Park W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72:1605-1612.

3.   Kay J, Smolen JS. Biosimilars to treat inflammatory arthritis: the challenge of proving identity. Ann Rheum Dis. 2013;72:1589-1593.

4.   World Health Organization. Expert Committee on Biological Standardization. Guidelines on evaluation of similar biotherapeutic products. October 19-23, 2009. http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf.  Accessed February 8, 2016.

5.   Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72:1613.