Subcutaneous infliximab CT-P13: biobetter for the use in rheumatology
Authors:
K. Urbánek
Authors‘ workplace:
Ústav farmakologie LF UP a FN Olomouc
Published in:
Čes. Revmatol., 31, 2023, No. 4, p. 197-202.
Overview
The term biobetter refers to a drug in the character of a recombinant protein, which, like a biosimilar, is a copy of the original drug; however, it is superior in some of its characteristics to the original. Subcutaneous infliximab CT-P13 meets the characteristics of a biobetter drug in terms of the use of an innovative dosage form, better pharmacokinetic properties, a higher probability of achieving the desired pharmacokinetic and pharmacodynamic target, and very likely lower immunogenicity. Possible improved clinical efficacy and safety are currently under investigation.
Keywords:
pharmacokinetics – rheumatoid arthritis – subcutaneous administration – immunogenicity – infliximab – biobetter
Sources
1. Breedveld FC. Therapeutic monoclonal antibodies. Lancet 2006; 355(9205): 735–740.
2. Keizer RJ, Huitema AD, Schellens JH, Beijnen JH. Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet 2010; 49(8): 493–507.
3. Strojil J. Biosimilars – specifika schvalovacího procesu v EU. Klin Farmakol Farm 2014: 28(1): 14–18.
4. Urbánek K. První biosimilární monoklonální protilátka – infliximab. Klin Farmakol Farm 2014; 28(1): 19–22.
5. Sandeep V, Parveen J, Chauhan P. Biobetters: the better biologics and their regulatory overview. Int J Drug Regul Aff 2016; 4: 13–20.
6. Torres-Obreque KM, Meneguetti GP, Muso-Cachumba JJ, Feitosa VA, Santos JHPM, Ventura SPM, et al. Building better biobetters: From fundamentals to industrial application. Drug Discov Today 2022; 27(1): 65–81.
7. Viola M, Sequeira J, Seiça R, Veiga F, Serra J, Santos AC, et al. Subcutaneous delivery of monoclonal antibodies: How do we get there? J Control Release 2018; 286: 301–314.
8. Sánchez-Félix M, Burke M, Chen HH, Patterson C, Mittal S. Predicting bioavailability of monoclonal antibodies after subcutaneous administration: Open innovation challenge. Adv Drug Deliv Rev 2020; 167: 66–77.
9. Alten R, An Y, Kim DH, Yoon S, Peyrin-Biroulet L. Re-routing Iinfliximab therapy: Subcutaneous infliximab opens a path towards greater convenience and clinical benefit. Clin Drug Investig 2022; 42(6): 477–489.
10. Verma AM, Patel A, Subramanian S, Smith PJ. From intravenous to subcutaneous infliximab in patients with inflammatory bowel disease: a pandemic-driven initiative. Lancet Gastroenterol Hepatol 2021; 6(2): 88–89.
11. Little RD, Ward MG, Wright E, Jois AJ, Boussioutas A, Hold GL, Gibson PR, Sparrow MP. Therapeutic drug monitoring of subcutaneous infliximab in inflammatory bowel disease-understanding pharmacokinetics and exposure response relationships in a new era of subcutaneous biologics. J Clin Med 2022; 11(20): 6173.
12. Iannone F, Conti F, Cauli A, Farina A, Caporali R. Subcutaneously-administered infliximab in the management of rheumatoid arthritis: a short narrative review of current clinical evidence. J Inflamm Res 2022; 15: 3259–3267.
13. Hamuro L, Kijanka G, Kinderman F, Kropshofer H, Bu DX, Zepeda M, et al. Perspectives on subcutaneous route of administration as an immunogenicity risk factor for therapeutic proteins.
J Pharm Sci 2017; 106(10): 2946–2954.
14. Jarvi NL, Balu-Iyer SV. Immunogenicity challenges associated with subcutaneous delivery of therapeutic proteins. BioDrugs 2021; 35(2): 125–146.
15. Janeway CA Jr, Travers P, Walport M, et al. Immunobiology: The immune system in health and disease. 5th edition. New York: Garland Science 2001. Available from: https://www.ncbi.nlm.nih.gov/books/NBK10757/
16. Westhovens R, Wiland P, Zawadzki M, Ivanova D, Kasay AB,
El-Khouri EC, et al. Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial. Rheumatology (Oxford) 2021; 14; 60(5): 2277–2287.
17. Kim H, Alten R, Cummings F, Danese S, D’Haens G, Emery P, et al. Innovative approaches to biologic development on the trail of CT-P13: biosimilars, value-added medicines, and biobetters. MAbs 2021; 13(1): 1868078.
18. Combe B, Allanore Y, Alten R, Caporali R, Durez P, Iannone F, et al. Comparative efficacy of subcutaneous (CT-P13) and intravenous infliximab in adult patients with rheumatoid arthritis: a network meta-regression of individual patient data from two randomised trials. Arthritis Res Ther 2021; 23(1): 119.
19. Constantin A, Caporali R, Edwards CJ, Fonseca JE, Iannone F, Keystone E, et al. Efficacy of subcutaneous vs intravenous infliximab in rheumatoid arthritis: a post-hoc analysis of a randomized phase III trial. Rheumatology (Oxford) 2023; 62(8): 2838–2844.
Labels
Dermatology & STDs Paediatric rheumatology RheumatologyArticle was published in
Czech Rheumatology
2023 Issue 4
Most read in this issue
- The most common panniculitis in rheumatology practice
- Rheumatoid arthritis therapy and liver disease
- CONTENT 2023
- Subcutaneous infliximab CT-P13: biobetter for the use in rheumatology