Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology

Abstract

Biologics are vital to the management of patients with rheumatic and musculoskeletal diseases such as rheumatoid arthritis and other inflammatory and autoimmune conditions. Nevertheless, access to these highly effective treatments remains an unmet medical need for many people around the world. As patents expire for existing licensed biologic (originator) products, biosimilar products can be approved by regulatory authorities and enter clinical use. Biosimilars are highly similar copies of originator biologics approved through defined and stringent regulatory processes after having undergone rigorous analytical, non-clinical, and clinical evaluations. The introduction of high-quality, safe, and effective biosimilars has the potential to expand access to these important medicines. Biosimilars are proven to be similar to the originator biologic in terms of safety and efficacy and to have no clinically meaningful differences. In contrast, "intended copies" are copies of originator biologics that have not undergone rigorous comparative evaluations according to the World Health Organization recommendations, but are being commercialized in some countries. There is a lack of information about the efficacy and safety of intended copies compared with the originator. Furthermore, they may have clinically significant differences in formulation, dosages, efficacy, or safety. In this review, we explore the differences between biosimilars and intended copies and describe key concepts related to biosimilars. Familiarity with these topics may facilitate decision making about the appropriate use of biosimilars for patients with rheumatic and musculoskeletal diseases.

Keywords: Biologic; Biosimilar; Intended copy; Pharmacovigilance; Regulatory.

Fig. 1

Biosimilar development process. Strong evidence of biosimilarity during analytical and non-clinical studies is essential. The objective of a biosimilar program was to establish biosimilarity, and the clinical program is focused and tailored toward this objective. Adapted from McCamish and Woolett [41], https://creativecommons.org/licenses/by-nc/3.0/us/legalcode

Fig. 2

Annual number of adverse drug reactions reported to the World Health Organization from 2010 to 2015 (inclusive; per million inhabitants) [89]