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ABSTRACT
Introduction: Biological disease-modifying anti-rheumatic drugs (bDMARDs), often administered in combination with methotrexate, target specific inflammatory mediators and have transformed the treatment of rheumatic diseases, especially rheumatoid arthritis (RA) but also the spondyloarthritides. However, the high cost of these drugs in many countries restricts patient access. As many bDMARDs have reached or are near to patent expiration, numerous biosimilar drugs are in development and some have already been approved. Biosimilars are generally priced lower than their reference products (RPs), or bio-originators, and as prices come down it is hoped that patient access to these drugs will increase, making the safety of these drugs an area of major interest.
Areas covered: This article reviews publicly available safety data on biosimilars in RA.
Expert opinion: Most available data for biosimilars in RA relate to tumor necrosis factor inhibitors (TNFi) and rituximab (an anti-CD20 monoclonal antibody). As biosimilar use around the world increases, evidence supporting the clinical safety of the biosimilars compared with their RPs also grows. To date, no new safety concerns have been raised in studies with TNFi or rituximab biosimilars for the treatment of RA; safety profiles have been consistent with those of their RPs. However, careful post-marketing pharmacovigilance remains necessary.
Article highlights
Biologic therapies targeting specific inflammatory cells and cytokines have transformed the treatment of RA.
As many biopharmaceuticals have reached or are near to patent expiry, biosimilars of these drugs have been developed.
Available data indicate that the safety profiles of biosimilars used to treat RA are similar to those of their RPs.
To date, no new safety concerns have been raised in prospective randomized clinical trials of various biosimilars or in post-marketing studies of the first approved biosimilar monoclonal antibody, CT-P13.
Most evidence collected to date indicates that transitioning from a bio-originator to its biosimilar does not result in any unexpected safety signals.
This box summarizes key points contained in the article.
Funding
Medical writing support was provided by Joanna Chapman PhD (Aspire Scientific Limited, Bollington, UK) and was funded by Celltrion Healthcare Co., Ltd (Incheon, Republic of Korea), but neither author received financial compensation for writing this paper.
Declaration of interest
J Braun has received research support and honoraria for talks from and has been a consultant to or on an advisory board for AbbVie; Amgen; Boehringer Ingelheim; Bristol-Myers-Squibb; Celgene; Celltrion; Centocor; Chugai Pharma; EBEWE Pharma; Janssen Biotech; Medac Pharma; MSD (Schering-Plough); Mundipharma; Novartis; Pfizer (Wyeth); Roche; Sanofi-Aventis and UCB Pharma. J Kay has received research support from AbbVie; Eli Lilly; Pfizer; Genentech; Roche and UCB Pharma and has been a consultant to AbbVie; Amgen; AstraZeneca; Boehringer Ingelheim; Bristol-Myers Squibb; Crescendo Bioscience; Eli Lilly; Epirus Biopharmaceuticals; Genentech; GlaxoSmithKline; Hospira; Janssen Biotech; MSD; Novartis; Pfizer; Samsung Bioepis; Sandoz; Roche and UCB Pharma. Medical writing support was provided by Joanna Chapman PhD (Aspire Scientific Limited, Bollington, UK) and was funded by Celltrion Healthcare Co., Ltd (Incheon, Republic of Korea). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.