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Biosimilars in inflammatory bowel disease

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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 development of biologic medication is comparatively long and the manufacturing process very expensive, resulting in a high cost for these agents.2 In Australia, the most expensive single drug in absolute dollar value for the 2015 financial year was adalimumab, with biologic agents making up five of the top eight most costly drugs and accounting for over 12% of the total PBS spend.3 Given the increasing incidence of diseases…