Update on biosimilars in rheumatology

Abstract

Biologic agents have become indispensable in the management of autoimmune disease particularly rheumatological conditions. The lives of countless individuals have been improved following treatment with these drugs. Unfortunately, their cost prohibits more widespread use around the globe. This critical issue has been addressed by the introduction of biosimilars into the market. These therapies have been developed to resemble the originator molecule as closely as possible and to increase competition in the therapy area thus allowing costs to be reduced. Our review is intended to offer an update on biosimilars including logistic considerations on their introduction into routine practice.

Effects of Message Framing on Patients’ Perceptions and Willingness to Change to a Biosimilar in a Hypothetical Drug Switch

“…"…why they need to use a different process." Lack of clinical trials 5 (5) "Not enough history…how many people tested it, where it's made." "Lack of studies to determine long-term effects on patients."…”

“…Biosimilars have the same clinical therapeutic equivalence, purity, and potency as their reference biologic and can provide the same health benefits at a significantly reduced cost (2,3). Biosimilars have been successfully incorporated into routine care for patients with rheumatic diseases in many countries (4,5). Estimates are that $100 billion worth of biologic medicines are coming off patent by 2020, which will create significant opportunities to integrate biosimilars into pharmaceutical markets and widen the opportunity for patients to benefit from such treatments (6).…”

Treatment Outcomes with Biosimilars: Be Aware of the Nocebo Effect

“…For reference biologics, the aim of the developmental process is to demonstrate de novo the risk-benefit profile of the candidate product [1]. However, during biosimilar development, the aim is to demonstrate high biosimilarity with the reference biologic in terms of structure, physicochemical attributes, and biologic activity, and to reconfirm the efficacy, safety, and immunogenicity profile as it was previously established by the reference biologic during its development process [1].…”

“…However, during biosimilar development, the aim is to demonstrate high biosimilarity with the reference biologic in terms of structure, physicochemical attributes, and biologic activity, and to reconfirm the efficacy, safety, and immunogenicity profile as it was previously established by the reference biologic during its development process [1]. The majority of effort in establishing similarity is performed during comprehensive non-clinical comparability exercises, whereupon any potential difference in terms of critical quality attributes between the biosimilar and reference biologic are more likely to be detected (Fig.…”

“…The loss of exclusivity of many biologics and the setting of a clear and robust regulatory approval pathway have paved the way for the introduction of more affordable biosimilars that, once developed, are rigorously evaluated to ensure similar molecular structure, efficacy, and safety to their reference biologics. Since 2007, more than 20 biosimilars have been approved by the European Medical Association (EMA), including the first biosimilar monoclonal antibody (mAb) CT-P13 (infliximab biosimilar), which was followed by SB4 (etanercept biosimilar) and SB2 (infliximab biosimilar) for the treatment of autoimmune diseases, such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, psoriasis, and inflammatory bowel disease [1,2]. Further biosimilars that have recently received EMA approval include ABP501 (adalimumab biosimilar), GP2015 (etanercept biosimilar), and GP2013 and CT-P10 (rituximab biosimilars) [3].…”