Cancer therapy has evolved significantly with increased adoption of biologic agents. When the patent on the cancer drug trastuzumab (Herceptin) expires next year, patients who have been receiving this biological therapy will have another treatment option: a biosimilar drug—a drug that is very similar, but not identical, to trastuzumab. The escalating cost of cancer care is placing an increasing burden on healthcare systems worldwide, largely a result of expensive biologic therapies
Biotherapeutic agents, also known as biologics, are large complex molecules that are produced in living systems. Biologics comprise a range of molecules with varying complexities, including peptides, such as human insulin; small proteins, like erythropoietin; and large molecules, including monoclonal antibodies.2 The use of biologics in the field of gastroenterology is largely confined to the treatment of the immune-mediated inflammatory bowel diseases (IBD), such as ulcerative colitis (UC) and Crohn’s disease (CD)
The treatment of rheumatic diseases have acknowledged that biosimilars and biologic DMARDs (bDMARDs) are interchangeable in clinical practice, except when patients experience lack of efficacy or tolerability with the reference agent. Given that cost is a barrier to effective bDMARD use, the introduction of less costly biosimilars is likely to widen access and dissipate treatment inequalities. Physicians faced with prescribing decisions should be reassured by the robust and exhaustive process that is involved in assuring comparability of biosimilars with their reference agents. De novo usage of a biosimilar and switching to a biosimilar following lack of efficacy or tolerability with a different reference biologic agent are likely to be strategies most easily adopted, although switching during successful treatment should also be considered given the potential cost implications.
There is no cure for inflammatory bowel disease (IBD), its symptoms can be treated and remission induced using biological medicines, including the anti-TNF (tumour necrosis factor) drug infliximab. Biosimilars of infliximab have been made available in guidelines from the British Society of Gastroenterology and the National Institute for Health and Care Excellence, and they represent a considerable cost-saving opportunity for the NHS. The potential difficulties of switching infliximab to a biosimilar at a hospital can be overcome with a two-step implementation process