References
- Biggioggero M, Crotti C, Becciolini A, et al. Tocilizumab in the treatment of rheumatoid arthritis: an evidence-based review and patient selection. Drug Des Devel Ther. 2019;13:57–70
- Srirangan S, Choy EH. The role of interleukin 6 in the pathophysiology of rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2010;2:247–256.
- Rubbert-Roth A, Furst DE, Nebesky JM, et al. A review of recent advances using tocilizumab in the treatment of rheumatic diseases. Rheumatol Ther. 2018;5:21–42*A
- Genentech, Inc. Actemra® (tocilizumab) injection, for intravenous or subcutaneous use. Highlights of prescribing information. South San Francisco (CA): Genentech, Inc.; 2021 cited 2021 Apr 7]. Available from 2021 Apr 7: https://www.gene.com/download/pdf/actemra_prescribing.pdf
- Roche Registration Gmb H. RoActemra 20 mg/mL concentrate for solution for infusion. Summary of product characteristics. Grenzach-Wyhlen: Roche Pharma AG; 2020 cited 2021 Apr 7]. Available from 2021 Apr 7: https://www.ema.europa.eu/en/documents/product-information/roactemra-epar-product-information_en.pdf
- US Food & Drug Administration. Coronavirus (COVID-19) update: FDA authorizes drug for treatment of COVID-19. June 24, 2021. Available at: cited 2021 Apr 07https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-drug-treatment-covid-19.
- European Medicines Agency. EMA recommends approval for use of RoActemra in adults with severe COVID-19. 06 December 2021. Available at: cited 2022 Feb 23https://www.ema.europa.eu/en/news/ema-recommends-approval-use-roactemra-adults-severe-covid-19.
- Gupta S, Padappayil RP, Bansal A, et al. Tocilizumab in patients hospitalized with COVID-19 pneumonia: systematic review and meta-analysis of randomized controlled trials. J Investig Med. 2022;70(1):55–60.
- Conti P, Pregliasco FE, Calvisi V, et al. Monoclonal antibody therapy in COVID-19. J Biol Regul Homeost Agents. 2021;35:423–427.
- Scott LJ. Tocilizumab: a review in rheumatoid arthritis. Drugs. 2017;77:1865–1879.
- Ahmed I, Kaspar B, Sharma U. Biosimilars: impact of biologic product life cycle and European experience on the regulatory trajectory in the United States. Clin Ther. 2012;34:400–419.
- US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. guideline for industry. Rockville (MD): US FDA; April 2015 [cited 2021 Apr 7]. Available from 2021 Apr 7: https://www.fda.gov/media/82647/download*Guidance for evaluating biosimilars
- European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. London: EMA; 2014 cited 2021 Apr 7]. Available from 2021 Apr 7: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-2.pdf
- Abdallah H, Hsu JC, Lu P, et al. Pharmacokinetic and pharmacodynamic analysis of subcutaneous tocilizumab in patients with rheumatoid arthritis from 2 randomized, controlled trials: SUMMACTA and BREVACTA. J Clin Pharmacol. 2017;57:459–468.
- Paccaly AJ, Kovalenko P, Parrino J, et al. Pharmacokinetics and pharmacodynamics of subcutaneous sarilumab and intravenous tocilizumab following single-dose administration in patients with active rheumatoid arthritis on stable methotrexate. J Clin Pharmacol. 2021;61:90–104.
- Zhang X, Georgy A, Rowell L. Pharmacokinetics and pharmacodynamics of tocilizumab, a humanized anti-interleukin-6 receptor monoclonal antibody, following single-dose administration by subcutaneous and intravenous routes to healthy subjects. Int J Clin Pharmacol Ther. 2013;51:443–455.
- European Medicines Agency. Guideline on the investigation of bioequivalence. London: EMA; 2010 cited 2021 Apr 12]. Available from 2021 Apr 12: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf
- Burmester GR, Choy E, Kivitz A, et al. Low immunogenicity of tocilizumab in patients with rheumatoid arthritis. Ann Rheum Dis. 2017;76:1078–1085.
- Zhang H, Li X, Liu J, et al. A randomized phase-I pharmacokinetic trial comparing the potential biosimilar tocilizumab (QX003S) with the reference product (Actemra®) in Chinese healthy subjects. Ann Med. 2021;53:375–383.
- Zhang H, Wang H, Wei H, et al. A phase I clinical study comparing the tolerance, immunogenicity, and pharmacokinetics of proposed biosimilar BAT1806 and reference tocilizumab in healthy Chinese men. Front Pharmacol. 2021;11:609522.
- Schreitmüller T, Barton B, Zharkov A, et al. Comparative immunogenicity assessment of biosimilars. Future Oncol. 2019;15:319–329.
- Pineda C, Castañeda Hernández G, Jacobs IA, et al. Assessing the immunogenicity of biopharmaceuticals. BioDrugs. 2016;30:195–206.
- Smolen JS, Landewé RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79:685–699.
- Kay J, Schoels MM, Dörner T, et al. Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. Ann Rheum Dis. 2018;77:165–174. •An evidence and consensus. •An evidence and consensusbased statement regarding the evaluation and use of biosimilars to treat rheumatological diseases from an international multidisciplinary task force on biosimilars.