HPE Biosimilars: Where are we and what is next? - Page 22


Impact of biosimilars : the case of immune-mediated disorders

A number of budget impact models have predicted substantial savings with the implementation of biosimilars for inflammatory diseases , and these savings can potentially be applied to improve patient access or care in other therapeutic areas
Carlo Selmi MD PhD Head , Rheumatology and Clinical Immunology , Humanitas Research Hospital ; Assistant Professor of Rheumatology , BIOMETRA Department , University of Milan , Italy
Immune-mediated or autoimmune diseases such as rheumatoid arthritis , psoriasis and inflammatory bowel disease , present heterogeneity in pathogenesis , clinical presentation , severity and prognosis , but cumulatively pose a significant burden to patients , caregivers , and the society , as well as health care systems . Traditionally , treatment has consisted in the administration of conventional disease-modifying agents ( for example , methotrexate for rheumatoid arthritis and psoriasis ); however , tremendous progress was made in the past two decades with the development and introduction in the market of biotechnological drugs ( namely monoclonal antibodies ( mAbs ; suffix -mab ); soluble receptors ( suffix -cept ); and receptor antagonists ( suffix -ra )), which stem from a fine understanding of the immune pathogenesis of chronic inflammation and autoimmunity to ultimately manage symptoms and slow disease progression . Despite the favourable efficacy and safety profile of biologics , the high costs associated with innovation , manufacturing and distribution process have limited patient access significantly . Biosimilars , which are designed to reproduce the reference product ( originator ) once the patent has expired , have received much attention from the medical community and payers alike , with the promise of substantial reductions in costs , and consequently of pressure on health care systems .
Biosimilars cannot be defined as bio-generics as their production may change depending on the time and site of production and based on the significantly larger size compared with chemical drugs . The biosimilar uptake by prescribers has not occurred entirely without hurdles , and different countries have defined specific regulatory pathways for approval and incentives for their use . Nonetheless , the benefits of biosimilars for patients can be
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