Celltrion Seeks Approval From FDA for CT-P47 as Biosimilar of Tocilizumab

Celltrion USA submitted a biologics license application for CT-P47, a biosimilar of tocilizumab (Actemra; Genentech), to the FDA.¹ Tocilizumab is an interleukin-6 (IL-6) receptor antagonist indicated for rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome.²

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Tocilizumab works by binding to the soluble and membrane IL-6 receptors and has demonstrated the ability to inhibit IL-6-mediated signaling through the receptors. IL-6 is a pro-inflammatory cytokine produced by T- and B-cells, lymphocytes, monocytes, and fibroblasts, according to the article.²

"The submission of CT-P47 for review is an important step toward providing patients with rheumatoid arthritis a more accessible avenue to treatment for conditions that present such a significant disease burden," Thomas Nusbickel, chief commercial officer at Celltrion USA, said in a statement. "We plan to lead the market by establishing a diverse product lineup in the autoimmune disease market in the US. We will continue to actively cooperate with the FDA's review in an effort to bring this new treatment option to [those] living with rheumatoid arthritis as soon as possible."¹

CT-P47 contains the active ingredient tocilizumab and is a recombinant humanized monoclonal antibody acting as an IL-6 receptor antagonist. The company is seeking approval for both the intravenous and subcutaneous admission routes.¹ The application is based on data from a phase 3 clinical trial that evaluated the efficacy, pharmacokinetics, safety, and immunogenicity of CT-P47 compared to tocilizumab for patients with moderate to severe active rheumatoid arthritis with an inadequate response to methotrexate for up to 52 weeks, according to the press release.¹

In a phase 1 study, CT-P47 was evaluated for its pharmacokinetic equivalence to tocilizumab in healthy Asian adults. According to the study results published in Expert Opinion on Investigational Drugs, 146 participants received CT-P47 and 143 received tocilizumab, which demonstrated equivalence for the time curve from last zero concentration, time curve from time zero to infinity, and maximum serum concentration.³

Furthermore, the ratios of geometric least-squares mean were within the margin of equivalence. Immunogenicity and safety were also comparable between the groups, according to the results. The pharmacokinetic equivalence was also comparable between the groups.³

The most common adverse reactions with tocilizumab include upper respiratory tract infection, nasopharyngitis, headache, hypertension, increased alanine transaminase, and injection site reactions.²

In December 2022, tocilizumab also became the first monoclonal antibody treatment for COVID-19, administered intravenously, according to an article from Pharmacy Times. The decision followed the FDA’s emergency use authorization which was issued in June 2021 for the drug’s use in those who were hospitalized and aged 2 years and older with COVID-19.⁴

References

1. Celltrion USA completes submission of Biologics License Application for CT-P47, a biosimilar candidate of ACTEMRA® (tocilizumab). News release. Celltrion. January 28, 2023. Accessed January 31, 2024. https://www.celltrion.com/en-us/company/media-center/press-release/3057
2. Arakelians S. Daily Medication Pearl: Tocilizumab (Actemra). Pharmacy Times. June 22, 2022. Accessed January 31, 2024. https://www.pharmacytimes.com/view/daily-medication-pearl-tocilizumab-actemra-
3. Yu KS, Kim B, Shin D, Park MK et al. Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 versus reference tocilizumab: a randomized, double-blind, single-dose phase I study. Expert Opin Investig Drugs. 2023;32(5):429-439. doi:10.1080/13543784.2023.2212155
4. Gallagher A. FDA Approves Tocilizumab as First Monoclonal Antibody Treatment of COVID-19. Pharmacy Times. December 22, 2022. Accessed January 31, 2024. https://www.pharmacytimes.com/view/fda-approves-tocilizumab-as-first-monoclonal-antibody-treatment-of-covid-19