Biosimilar development and utilization, as well as non-biological oral agents with unique pathological targets, will continue to dominate efforts to improve patient access and reduce the overall cost of care as non-surgical treatments for Crohn’s disease and ulcerative colitis in adults and children. Therapeutic drug monitoring, combined with inflammatory biomarkers, have become the standard of care to assess effectiveness.
In his commentary, US researcher Richard Parrish summarizes a collection of key references published within the last 10 years, and identifies pharmacologic research directions to improve treatment access and success through greater use of biosimilars combined with other targeted small molecule agents that possess unique pathophysiologic mechanisms for inflammatory bowel disease (IBD) in adult and paediatric patients [1].
He found that while there is ample evidence to assert that biosimilars for infliximab and adalimumab are comparable to the reference product in moderate to severe IBD, slow uptake of biosimilar use may be due to lack of third-party insurance coverage for multiple reasons (including contractual reference product rebates to pharmacy benefit managers), patent disputes in court related to approved indications and reference product manufacturer market strategies that limit use.
Combinations of antitumour necrosis factor-alpha (anti-TNF-α) biosimilars with anti-adhesion, anti-integrin and interleukin 12/23 antagonists (more common in children than in adults), as well as Janus kinase inhibitors (tofacitinib, peficitinib, upadacitinib, filgotinib), sphingo-sine-1-phosphate [S1P] receptor modulators (ozanimod, etrasimod), phosphodiester-ase-4 inhibitors (apremilast), selective histone deacetylase 3 inhibitors (givinostat, vorinostat) and/or substitutions of phosphatidylcholine, i.e. agents with different mechanisms of action, are on research agendas in various phases and treatment horizons. The development of these non-biological small molecules that can be absorbed orally or affect the colonic lumen topically will be vital for the achievement of sustained clinical remission in adults and children.
Dr Parrish concluded that future research should quantify the relative contribution of each of these choices to overall treatment success. Patient and provider education and positive framing of non-medical switching strategies needs to be incorporated into organized programmes for both adult and paediatric populations, including parents and caregivers, so that the negative attribution towards biosimilar initiation or switching is minimized. Psychosocial issues often impact the development and progress of IBD and are best approached through a multidisciplinary approach. Early attention to growth and development in children is paramount to optimal physical and psychological well-being. Research to elucidate pharmacotherapies of choice for anxiety, depression and pain is needed in children and adults. Oral liquid formulations for children and those that cannot swallow non-biological oral solid dosage forms used in combination will be important for continued success in treating vulnerable patient populations.
Conflict of interest
The author of the research paper [1] declared that there was no conflict of interest.
Abstracted by Professor Richard H Parrish, Professor of Pharmacology, Department of Biomedical Sciences Mercer University School of Medicine, Macon, Georgia, USA.
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USA and Europe differ in interchangeability of biosimilars
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Reference
1. Parrish RH. Biosimilar interchangeability and emerging treatment strategies for inflammatory bowel diseases: a commentary. Gastroenterol Insights. 2021;12:293-301.
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