An Update on Biosimilars in Rheumatic and Musculoskeletal Disorders

Abstract

Biosimilars contain a version of the active substance of an approved biologic medicine. They were introduced several years ago; the first biosimilar was approved by the European Medicine Agency in 2006. They are now commonly used to treat several immune-mediated conditions, and large evidence-based national and international guidelines support their use. Biosimilars are licensed for use after going through a comprehensive approval process to demonstrate clinical equivalence to the reference biologic in at least one randomized controlled trial. Once biosimilarity is demonstrated in one indication, this can be used to approve the drug for other indications if the mechanism of action is the same across different indications. Biosimilars do not have any clinically meaningful differences from the originator medicine in terms of quality, safety and efficacy but have a cost-saving benefit. NHS England supports the use of biosimilars, stating that clinicians should use the best-value biological product, including biosimilars. In 2021, the National Institute for Health and Care Excellence lowered the biologic eligibility criteria for rheumatoid arthritis by recommending the use of anti-tumour necrosis factor medications with licensed biosimilars for treating moderate rheumatoid arthritis after conventional disease-modifying anti-rheumatic drugs have failed. This recommendation has enabled more patients to access advanced therapy at an earlier stage of the disease, thus potentially increasing the likelihood of inducing remission and limiting disease progression.