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.

An Empirical Analysis of the Perceived Challenges and Benefits of Introducing Biosimilars in Bangladesh: A Paradigm Shift

“…Similar to most other countries in the region such as Pakistan and India, it possesses well-structured regulatory pathways for the approval of pharmaceuticals [16]. Under the current national policy, raw materials locally manufactured are protected by restrictions on their import unless adequate quantity of the material is present within the local industry.…”

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

“…43 Non-comparable biotherapeutics have also been referred to as “biomimics” and “intended copies” (the term we use hereafter). 44 In some cases, these products have been licensed prior to the implementation of biosimilar guidelines, via regulatory pathways not appropriate for biologics, such as those used for generic drugs. 43,44 Unlike biosimilars, intended copies lack clear evidence of similarity in quality, safety, and efficacy to the corresponding originator biologic.…”

“…2,16,44,57 A 2016 systematic literature review found that most comparative studies reported for such intended copies were either analytical, non-clinical, or observational in nature; as such, there remains a significant dearth of published data demonstrating the safety and efficacy of these agents. 16 …”

“…44,45 In Mexico, for example, there were 23 intended copies, or “biolimbos,” on the market before the country’s biosimilar guidelines came into effect, and the regulator COFEPRIS has requested that the manufacturers conduct assessments to demonstrate the biosimilarity of these agents and the corresponding originator products. 63 The WHO has issued guidance recommending a stepwise approach to reviewing all authorized biologics and identifying those licensed on the basis of data that do not meet current regulatory expectations.…”

Biosimilars Revolution

“…However, the FDA was quick to highlight that it was not approved as an interchangeable product and instead, is merely an option that could potentially expand access to treatment for patients. 3 The American College of Rheumatology (ACR) applauded the decision citing a potential cost savings for patients, but they also expressed concerns over the need for distinct names and transparent labeling for all biosimilar products to ensure correct prescribing and dispensing, post-marketing surveillance, prescriber confidence and enhanced market uptake. There are over 700 biosimilar products in preclinical and clinical trials.…”