Overview of biosimilars for immune-mediated inflammatory diseases: summary of current evidence.

Overview

Biosimilars offer the potential to deliver substantial cost savings in biologic therapy and to contribute to increased patient access to biologic treatments, both of which are particularly relevant for immune-mediated inflammatory diseases, given the number of patients affected by and receiving treatment for these conditions. For the United States to benefit from bringing biosimilar pipeline products to the market, legal and price-related barriers to competition must be addressed. In addition, education of prescribers, patients, payers, and providers is essential to increase uptake as biosimilars reach the market. This article discusses biosimilars currently available for the treatment of immune-mediated inflammatory diseases in the United States, reviews the main concepts related to regulatory approval of biosimilars by the FDA, and considers potential barriers to the uptake of biosimilars.