Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity
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REVIEW
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity Tom W. J. Huizinga
. Yoshifumi Torii . Rafael Muniz
Received: October 5, 2020 / Accepted: November 12, 2020 Ó The Author(s) 2020
ABSTRACT Although treatment with biologic diseasemodifying antirheumatic drugs (bDMARDs) has significantly improved clinical outcomes in patients with rheumatoid arthritis (RA), many patients do not have access to these treatments. As cost-effective alternatives to their reference products (RPs), biosimilars provide an opportunity to increase access to bDMARDs. The European Medicines Agency and the US Food and Drug Administration have detailed pathways for the approval of biosimilars based on establishing the similarity of the biosimilar to the RP in terms of structure and function, pharmacokinetics (PK), efficacy, safety, and immunogenicity. A number of biosimilars of adalimumab, infliximab, etanercept, and rituximab RPs have been approved in the United States and/or European Union. This article is focused on the seven adalimumab biosimilars. A review of the data for the biosimilars FKB327, ABP 501, BI 695501, GP2017, MSB11022, PF-06410293, and SB5 confirm that these products are highly T. W. J. Huizinga (&) Leiden University, Leiden, The Netherlands e-mail: [email protected] Y. Torii Fujifilm Kyowa Kirin Biologics, Tokyo, Japan R. Muniz Mylan Inc., Canonsburg, PA, USA
similar to the adalimumab RP with regard to structure, physicochemical and biological properties, PK, safety, immunogenicity, and efficacy in the treatment of RA and other chronic immune-mediated, inflammatory conditions. Data from several switching studies showed no changes in efficacy, safety, trough serum drug concentration, or immunogenicity between the biosimilars and their RP. Trial registration: ClinicalTrials.gov identifiers: NCT02260791, NCT02405780, NCT0197 0475, NCT02137226, NCT02045979, NCT027 44755, NCT02144714, NCT02167139, NCT030 14947, NCT02114931, NCT02640612, NCT026 40612, NCT02167139, NCT03052322, NCT024 80153. EudraCT numbers: 2012-005140-23, 2012-000785-37, 2013-003722-84, 2015-0005 79-28, 2014-002879-29, 2014-000662-21, 2013004654-13, 2015-002634-41, 2014-005229-11, 2016-002852-26, 2014-000352-29
PLAIN LANGUAGE SUMMARY Biologic disease-modifying antirheumatic drugs (bDMARDs) improve outcomes for patients with rheumatoid arthritis (RA); however, many patients do not have access to these treatments. Biosimilars offer a cost-effective alternative to their reference product (RP) and provide the opportunity to increase access to bDMARDs.
Rheumatol Ther
This article reviews available data regarding the pharmacokinetics (PK), safety, immunogenicity, and effectiveness of the adalimumab RP and its biosimilars (FKB327, ABP 501, BI 695501, GP2017, MSB11022, PF-06410293, and SB5) in the treatment of RA. Based on the published literature, we concluded that these products are similar to the adalimumab RP in terms of their structure, physicochemical and biological properties, an
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