1,925
Views
0
CrossRef citations to date
0
Altmetric
Original Research

Pharmacokinetics and tolerability of prefilled syringe and auto-injector presentations of MSB11456: results of a randomized, single-dose study in healthy adults

ORCID Icon, , , , , & show all
Pages 447-455 | Received 23 Nov 2022, Accepted 27 Jan 2023, Published online: 15 Feb 2023

References

  • World Health Organization (WHO). Prequalified Medicinal Products. Tocilizumab. Reference BT-CV001 (a). World Health Organization Prequalification Team (10 February 2022).
  • Genentech. Actemra®(tocilizumab) injection, for intravenous or subcutaneous use. Highlights of prescribing information. 2022. South San Francisco (CA). [Online]. [cited 2023 Feb 6]. Available from: https://www.gene.com/download/pdf/actemra_prescribing.pdf
  • Shetty A, Hanson R, Korsten P, et al. Tocilizumab in the treatment of rheumatoid arthritis and beyond. Drug Des Devel Ther. 2014;8:349–364.
  • Navarro-Millán I, Singh JA, Curtis JR. Systematic review of tocilizumab for rheumatoid arthritis: a new biologic agent targeting the interleukin-6 receptor. Clin Ther. 2012 Apr;34(788–802.e3):788–802.e3.
  • 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;18:533–543.
  • Overton PM, Shalet N, Somers F, et al. Patient Preferences for Subcutaneous versus Intravenous Administration of Treatment for Chronic Immune System Disorders: a Systematic Review. Patient Prefer Adherence. 2021;15:811–834.
  • Stoner KL, Harder H, Fallowfield LJ, et al. Intravenous versus Subcutaneous Drug Administration Which Do Patients Prefer? A Systematic Review. Patient 2014;8:145–153.
  • Besada E. Potential patient benefit of a subcutaneous formulation of tocilizumab for the treatment of rheumatoid arthritis: a critical review. Patient Prefer Adherence. 2014;8:1051.
  • Dashiell-Aje E, Harding G, Pascoe K, et al. Patient Evaluation of Satisfaction and Outcomes with an Autoinjector for Self-Administration of Subcutaneous Belimumab in Patients with Systemic Lupus Erythematosus. Patient. 2018;11(1):119–129.
  • Fettner S, Mela C, Wildenhahn F, et al. Evidence of bioequivalence and positive patient user handling of a tocilizumab autoinjector. Expert Opin Drug Deliv. 2019;16(5): 551–561.
  • Martin UJ, Fuhr R, Forte P, et al. Comparison of autoinjector with accessorized prefilled syringe for benralizumab pharmacokinetic exposure: AMES trial results. J Asthma. 2021;58(1): 93–101.
  • Hu P, Wang J, Florian J, et al. Systematic Review of Device Parameters and Design of Studies Bridging Biologic-Device Combination Products Using Prefilled Syringes and Autoinjectors. AAPS J. 2020;22(2). DOI:10.1208/s12248-020-0433-8.
  • Dua P, Hawkins E, Van Der Graaf P. A Tutorial on Target-Mediated Drug Disposition (TMDD) Models. CPT Pharmacometrics Syst Pharmacol. 2015;4(6):324–337.
  • Smit C, De Hoogd S, Rjm B, et al. Obesity and drug pharmacology: a review of the influence of obesity on pharmacokinetic and pharmacodynamic parameters. Expert Opin Drug Metab Toxicol. 2018;14(3):275–285.
  • Leung E, Crass RL, Jorgensen SCJ, et al. Pharmacokinetic/Pharmacodynamic Considerations of Alternate Dosing Strategies of Tocilizumab in COVID-19. Clin Pharmacokinet. 2022;61(2):155–165.
  • Gradel AKJ, Porsgaard T, Lykkesfeldt J, et al. Factors Affecting the Absorption of Subcutaneously Administered Insulin: effect on Variability. J Diabetes Res. 2018;2018:1–17.
  • Sabet A, Dickerson DS, Kunina EE, et al. A Randomised Controlled Trial Comparing the Pharmacokinetics and Tolerability of the Proposed Adalimumab Biosimilar MSB11022 Delivered via Autoinjector and Pre-filled Syringe in Healthy Subjects. Rheumatol Ther. 2022;9(2):693–704.
  • Lon H-K, Cheng L, Nudurupati S, et al. Pharmacokinetic Comparability of Risankizumab Formulations in Prefilled Syringe and Auto-injector for Subcutaneous Injection. Clin Ther. 2021;43(3):629–636.
  • Stauffer VL, Sides R, Lanteri-Minet M, et al. Comparison between prefilled syringe and autoinjector devices on patient-reported experiences and pharmacokinetics in galcanezumab studies. Patient Prefer Adherence. 2018;12:1785–1795.
  • Ramael S, Moschetti V, Peter N, et al. AB0391 Similar pharmacokinetics, safety and tolerability of the Adalimumab biosimilar candidate BI 695501 administered subcutaneously via prefilled syringe (PFS) or autoinjector (AI) (Voltaire®-ai). BMJ. 2017;76:1185.
  • Cherniakov I, Cohen‐Barak O, Tiver R, et al. A Pharmacokinetic Bioequivalence Study of Fremanezumab Administered Subcutaneously Using an Autoinjector and a Prefilled Syringe. Clin Pharmacol Drug Dev. 2021;10(9): 1018–1027.
  • Cohen YZ, Zhang X, Xia B, et al. Pharmacokinetics of Subcutaneous Dupilumab Injection with an Autoinjector Device or Prefilled Syringe. Clin Pharmacol Drug Dev. 2022;11:675–681.
  • Hupperts R, Becker V, Friedrich J, et al. Multiple sclerosis patients treated with intramuscular IFN-β-1a autoinjector in a real-world setting: prospective evaluation of treatment persistence, adherence, quality of life and satisfaction. Expert Opin Drug Deliv. 2015;12(1): 15–25.