Review of Biosimilar Trials and Data on Adalimumab in Rheumatoid Arthritis

Abstract

Purpose of Review: Adalimumab is one of the top-selling drugs worldwide. Its imminent patent expiration has seen the emergence of numerous biosimilar agents. In this article, we recap the evidence from bio-originator trials in rheumatoid arthritis (RA) to provide context for a critical review of biosimilar trial data. Recent Findings: Currently, three adalimumab biosimilars are approved in Europe and/or the USA: Amgen’s ABP 501 (AMJEVITA/Solymbic), Boehringer Ingelheim’s BI 695501 (Cyltezo) and Samsung Bioepis’s SB5 (Imraldi). All three agents met their pre-specified equivalence criteria. Subtle differences in adverse events and clinical responses between the reference and biosimilar products were noted. Summary: The introduction of adalimumab biosimilars will offer exciting opportunities in improving treatment access and increasing treatment options for RA and other licensed indications. Real-world data will further provide assurances on efficacy as well as safety.