The treatment of rheumatoid arthritis provides a clear argument in favour of developing biosimilars and the need to collect sufficient pharmacological data to validate their bioequivalence and interchangeability.
The costs to society of treating rheumatoid arthritis are high. The introduction of biological disease-modifying anti-rheumatic drugs (B-DMARDs) has improved the outlook for patients not fully responding to conventional DMARDs, but they are expensive. The cost savings to be made by using less expensive biosimilar products with comparable efficacy and safety to B-DMARDs is discussed by Professors Giovanni Lapadula and Gianfranco Ferracioli.
In one example, use of tumour necrosis factor (TNF)-antagonists (infliximab, etanercept and adalimumab) was compared to use of conventional DMARDs, e.g. hydroxychloroquine, methotrexate, intramuscular gold, sulphasalazine and leflunomide. The results of the study showed an estimated discounted mean lifetime cost of nearly GBP 58,000 for TNF-antagonist therapy versus around GBP 21,000 for therapy with conventional DMARDs, although the TNF-antagonists produced more quality-adjusted life-years (QALYs).
This study, amongst others, highlights the huge cost savings to be made from the use of biosimilars. Lapadula notes as an example the Euros 8 billion projected savings to be made in Germany with the use of biosimilar erythropoietin.
FDA has yet to approve a biosimilar. In Europe, EMA has already approved two applications for marketing authorization of infliximab biosimilars. The positive decision by EMA paves the way for cheaper biosimilars to hit the market once the patents for Remicade expire, which will happen in Europe in 2014 and in the US in 2018.
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