Abstract
Biosimilars have revolutionized the field of biologic disease-modifying antirheumatic drugs by significantly bringing down the cost of therapy. This has resulted in a wider reach of these molecules. With the expiration of patents for originator molecules, biosimilars have become widely available throughout the world including the USA and Europe. Since all biologic drugs are proteins produced inside living cells, biosimilars may not be identical to the originator drug, but they exhibit similarity in efficacy and safety without any clinically meaningful differences. Stringent regulations guide assessment of immunogenicity, pharmacokinetics, and pharmacodynamics of a proposed biosimilar. Intentional as well as unintentional changes do occur in the productions of biotherapeutics, the regulations however focus on the properties of a proposed biosimilar being within a predetermined range of the originator drug. Switching between originator and its biosimilar, between biosimilars, and extrapolation of indications are areas that will be better understood with more clinical experience with these agents.
Declaration: The table included in the manuscript is original.
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Goyal, M., Ravindran, V. (2022). Biosimilars in Rheumatology. In: Jain, N., Duggal, L. (eds) Handbook of Biologics for Rheumatological Disorders. Springer, Singapore. https://doi.org/10.1007/978-981-16-7200-2_24
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