References
- Tanaka T, Narazaki M, Kishimoto T. Interleukin (IL-6) immunotherapy. Cold Spring Harb Perspect Biol. 2018;10(8):a028456.
- US Food and Drug Administration. Actemra prescribing information (2022). [cited 2023 Mar 20]; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125276s138lbl.pdf.
- European Medicines Agency. RoActemra assessment report (2009). [cited 2023 Mar 20]; Available from: https://www.ema.europa.eu/en/documents/assessment-report/roactemra-epar-public-assessment-report_en.pdf.
- US Food and Drug Administration. Actemra prescribing information (original approval) (2010). [cited 2023 Mar 20]; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125276lbl.pdf.
- European Medicines Agency. RoActemra summary of product characteristics (2022). [cited 2023 Mar 20]; Available from: https://www.ema.europa.eu/en/documents/product-information/roactemra-epar-product-information_en.pdf.
- Isaacs JD, Cutolo M, Keystone EC, et al. Biosimilars in immune-mediated inflammatory diseases: initial lessons from the first approved biosimilar anti-tumour necrosis factor monoclonal antibody. J Intern Med. 2016;279(1):41–59. DOI:10.1111/joim.12432
- Baumgart DC, Misery L, Naeyaert S, et al. Biological therapies in immune-mediated inflammatory diseases: can biosimilars reduce access inequities? Front Pharmacol. 2019;10:279.
- Bergstra SA, Branco JC, Vega-Morales D, et al. Inequity in access to bDMARD care and how it influences disease outcomes across countries worldwide: results from the METEOR-registry. Ann Rheum Dis. 2018;77(10):1413–1420. DOI:10.1136/annrheumdis-2018-213289
- US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry (2015). [cited 2023 Mar 20]; Available from: https://www.fda.gov/media/82647/download.
- European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (2014). [cited 2023 Mar 20]; Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-2.pdf.
- European Medicines Agency. Medicines (biosimilar) (2023). [cited 2023 Mar 20]; Available from: https://www.ema.europa.eu/en/medicines/search_api_aggregation_ema_medicine_types/field_ema_med_biosimilar?search_api_views_fulltext=tocilizumab.
- US Food and Drug Administration. Biosimilar product information (2023). [cited 2023 Mar 20]; Available from: https://www.fda.gov/drugs/biosimilars/biosimilar-product-information.
- 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(1):375–383. DOI:10.1080/07853890.2021.1887925.
- 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. DOI:10.3389/fphar.2020.609522.
- Schwabe C, Illes A, Ullmann M, et al. Pharmacokinetics and pharmacodynamics of a proposed tocilizumab biosimilar MSB11456 versus both the US-licensed and EU-approved products: a randomized, double-blind trial. Expert Rev Clin Immunol. 2022;18(5):533–543. DOI:10.1080/1744666X.2022.2060204.
- Tomaszewska-Kiecana M, Ullmann M, Petit-Frere C, et al. Pharmacokinetics of a proposed tocilizumab biosimilar (MSB11456) versus US-licensed tocilizumab: results of a randomized, double-blind, single-intravenous dose study in healthy adults. Expert Rev Clin Immunol. 2023;19(4):439–446. DOI:10.1080/1744666x.2023.2174104.
- Mehr S. Tocilizumab biosimilars approaching: developments on three fronts. (2022). [cited 2023 Mar 20]; Available from: https://biosimilarsrr.com/2022/08/18/tocilizumab-biosimilars-approaching-developments-on-three-fronts/.
- Sampson HA, Munoz-Furlong A, Campbell RL, et al. Second symposium on the definition and management of anaphylaxis: summary report–Second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J Allergy Clin Immunol. 2006;117(2):391–397. DOI:10.1016/j.jaci.2005.12.1303
- US Food and Drug Administration. Clinical pharmacology data to support a demonstration of biosimilarity to a reference product: guidance for industry (2016). [cited 2023 Mar 20]; Available from: https://www.fda.gov/media/88622/download.
- Zhang X, Peck R. Clinical pharmacology of tocilizumab for the treatment of patients with rheumatoid arthritis. Expert Rev Clin Pharmacol. 2011;4(5):539–558. DOI:10.1586/ecp.11.33.
- Burmester GR, Choy E, Kivitz A, et al. Low immunogenicity of tocilizumab in patients with rheumatoid arthritis. Ann Rheum Dis. 2017;76(6):1078–1085. DOI:10.1136/annrheumdis-2016-210297.
- de Lusignan S, Dorward J, Correa A, et al. Risk factors for SARS-CoV-2 among patients in the Oxford Royal College of General Practitioners Research and Surveillance Centre primary care network: a cross-sectional study. Lancet Infect Dis. 2020;20(9):1034–1042. DOI:10.1016/S1473-3099(20)30371-6
- Meister T, Pisarev H, Kolde R, et al. Clinical characteristics and risk factors for COVID-19 infection and disease severity: a nationwide observational study in Estonia. PLoS ONE. 2022;17(6):e0270192. DOI:10.1371/journal.pone.0270192
- Im C, Kim Y. Local characteristics related to SARS-CoV-2 transmissions in the Seoul metropolitan area, South Korea. Int J Environ Res Public Health. 2021;18(23):12595.
- World Health Organization. WHO coronavirus (COVID-19) dashboard (2023). [cited 2023 Mar 20]; Available from: https://covid19.who.int/.
- 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(6):443–455. DOI:10.5414/CP201819.
- Morcos PN, Zhang X, McIntyre C, et al. Pharmacokinetics and pharmacodynamics of single subcutaneous doses of tocilizumab administered with or without rHuph20. Int J Clin Pharmacol Ther. 2013;51(7):537–548. DOI:10.5414/CP201847.
- Favalli EG, Biggioggero M, Crotti C, et al. Sex and management of rheumatoid arthritis. Clin Rev Allergy Immunol. 2019;56(3):333–345. DOI:10.1007/s12016-018-8672-5
- US Food and Drug Administration. Actemra medical review (2013). [cited 2023 Mar 20]; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125472Orig1s000MedR.pdf.
- ClinicalTrials.gov. A study to compare efficacy and safety of CT-P47 and RoActemra in patients with rheumatoid arthritis (NCT05489224) (2022). [cited 2023 Mar 20]; Available from: https://clinicaltrials.gov/ct2/show/NCT05489224.