Critical appraisal and future outlook on anti-inflammatory biosimilar use in chronic immune-mediated inflammatory diseases.

Biosimilars represent a novel category in the world of follow-up medicinal products with the requirement that they are highly similar but not identical to an approved originator biologic medicine, with no clinically meaningful differences in safety, purity, and potency. In this review, we discuss recent pivotal biosimilar developments for anti-inflammatory therapy in rheumatology, gastroenterology, and dermatology, and the influence of biosimilar availability on patients and payers. Finally, we provide our perspective on the evolution of biosimilar use in these indications in the United States (US) and in Europe and on where this evolution in biopharmaceuticals may lead in the future. Although biosimilars are commonly used in the European Union (EU), there will be an inevitable sea change of acceptance by clinicians, patients, payers, and regulators in the US. It is paramount to educate about biosimilarity, highlighting currently available data gathered from other geographies, in addition to gradually providing clinicians and patients with the necessary experience with these agents ultimately restoring competition in the biologics landscape.
(Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)