Cost savings are welcome but evidence supporting equivalence of biosimilar and originator drugs is currently limited
The management of inflammatory bowel disease has undergone major changes in the last decade with the availability on the Pharmaceutical Benefits Scheme (PBS) of targeted biological therapies. The first of these was the anti-tumour necrosis factor α (anti-TNF-α) monoclonal antibody infliximab, followed by another anti-TNF-α antibody adalimumab, and, more recently, the first gut-specific T-cell trafficking inhibitor vedolizumab, an anti-α-4 β-7 integrin monoclonal antibody. These drugs have resulted in a shift in the management paradigm from symptom control and the minimisation of exposure to corticosteroids to now aiming for healing of the intestinal mucosa, prevention of damage and subsequent disability.1
The full article is accessible to AMA members and paid subscribers. Login to read more or purchase a subscription now.
Please note: institutional and Research4Life access to the MJA is now provided through Wiley Online Library.
- 1. De Cruz P, Kamm MA, Prideaux L, et al. Mucosal healing in Crohnʼs disease. Inflamm Bowel Dis 2013; 19: 429-444.
- 2. Gecse KB, Khanna R, van den Brink GR, et al. Biosimilars in IBD: hope or expectation? Gut 2013; 62: 803-807.
- 3. Pharmaceutical Benefits Scheme. Expenditure and prescriptions twelve months to 30 June 2015. https://www.pbs.gov.au/statistics/2014-2015-files/exp-prs-book-01-2014-15.pdf (accessed June 2016).
- 4. Australian Government Department of Health. Pharmaceutical Benefits Scheme. Biosimilar medicines — factsheet for healthcare professionals. http://www.pbs.gov.au/info/publication/factsheets/biosimilars/biosimilar-medicines-factsheet-for-healthcare-professional (accessed June 2016).
- 5. Park W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 2013; 72: 1605-1612.
- 6. Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 2013; 72: 1613-1620.
- 7. Australian Government Department of Health. Pharmaceutical Benefits Scheme price disclosure arrangements. Procedural and operational guidelines. Canberra: DoH, 2014.
- 8. Moss AC, Brinks V, Carpenter JF. Review article: immunogenicity of anti-TNF biologics in IBD — the role of patient, product and prescriber factors. Aliment Pharmacol Ther 2013; 38: 1188-1197.
- 9. Park W, Yoo DH, Miranda P, et al. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis 2016; doi: 10.1136/annrheumdis-2015-208783 [Epub ahead of print].
- 10. Yoo DH, Prodanovic N, Jaworski J, et al. Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis 2016; doi: 10.1136/annrheumdis-2015-208786 [Epub ahead of print].
- 11. Allez M, Karmiris K, Louis E, et al. Report of the ECCO pathogenesis workshop on anti-TNF therapy failures in inflammatory bowel diseases: Definitions, frequency and pharmacological aspects. J Crohn’s Colitis 2010; 4: 355-366.
- 12. Ben Horin S, Yavzori M, Benhar I, et al. Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima. Gut 2016; 65: 1132-1138.
- 13. van Schie KA, Wolbink G-J, Rispens T. Cross-reactive and pre-existing antibodies to therapeutic antibodies — effects on treatment and immunogenicity. mAbs 2015; 7: 662-671.
- 14. Therapeutic Goods Administration. Regulation of biosimilar medicines. Canberra: Commonwealth of Australia, 2015. https://www.tga.gov.au/sites/default/files/evaluation-biosimilars-151217_0.pdf (accessed June 2016).
I am the current chair of the Australian Inflammatory Bowel Disease Association of the Gastroenterological Society of Australia, a board member of Crohn’s & Colitis Australia, and have been on advisory boards and/or received speaker fees from the following manufacturers of biological medicinesAbbVie, Janssen, Hospira and Takeda.