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Review of Biosimilar Trials and Data on Adalimumab in Rheumatoid Arthritis

PURPOSE OF REVIEW: Adalimumab is one of the top-selling drugs worldwide. Its imminent patent expiration has seen the emergence of numerous biosimilar agents. In this article, we recap the evidence from bio-originator trials in rheumatoid arthritis (RA) to provide context for a critical review of bio...

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Autores principales: Zhao, Sizheng, Chadwick, Laura, Mysler, Eduardo, Moots, Robert J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6097048/
https://www.ncbi.nlm.nih.gov/pubmed/30094742
http://dx.doi.org/10.1007/s11926-018-0769-6
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author Zhao, Sizheng
Chadwick, Laura
Mysler, Eduardo
Moots, Robert J.
author_facet Zhao, Sizheng
Chadwick, Laura
Mysler, Eduardo
Moots, Robert J.
author_sort Zhao, Sizheng
collection PubMed
description PURPOSE OF REVIEW: Adalimumab is one of the top-selling drugs worldwide. Its imminent patent expiration has seen the emergence of numerous biosimilar agents. In this article, we recap the evidence from bio-originator trials in rheumatoid arthritis (RA) to provide context for a critical review of biosimilar trial data. RECENT FINDINGS: Currently, three adalimumab biosimilars are approved in Europe and/or the USA: Amgen’s ABP 501 (AMJEVITA/Solymbic), Boehringer Ingelheim’s BI 695501 (Cyltezo) and Samsung Bioepis’s SB5 (Imraldi). All three agents met their pre-specified equivalence criteria. Subtle differences in adverse events and clinical responses between the reference and biosimilar products were noted. SUMMARY: The introduction of adalimumab biosimilars will offer exciting opportunities in improving treatment access and increasing treatment options for RA and other licensed indications. Real-world data will further provide assurances on efficacy as well as safety.
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spelling pubmed-60970482018-08-24 Review of Biosimilar Trials and Data on Adalimumab in Rheumatoid Arthritis Zhao, Sizheng Chadwick, Laura Mysler, Eduardo Moots, Robert J. Curr Rheumatol Rep Biosimilars (E Mysler, Section Editor) PURPOSE OF REVIEW: Adalimumab is one of the top-selling drugs worldwide. Its imminent patent expiration has seen the emergence of numerous biosimilar agents. In this article, we recap the evidence from bio-originator trials in rheumatoid arthritis (RA) to provide context for a critical review of biosimilar trial data. RECENT FINDINGS: Currently, three adalimumab biosimilars are approved in Europe and/or the USA: Amgen’s ABP 501 (AMJEVITA/Solymbic), Boehringer Ingelheim’s BI 695501 (Cyltezo) and Samsung Bioepis’s SB5 (Imraldi). All three agents met their pre-specified equivalence criteria. Subtle differences in adverse events and clinical responses between the reference and biosimilar products were noted. SUMMARY: The introduction of adalimumab biosimilars will offer exciting opportunities in improving treatment access and increasing treatment options for RA and other licensed indications. Real-world data will further provide assurances on efficacy as well as safety. Springer US 2018-08-09 2018 /pmc/articles/PMC6097048/ /pubmed/30094742 http://dx.doi.org/10.1007/s11926-018-0769-6 Text en © The Author(s) 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Biosimilars (E Mysler, Section Editor)
Zhao, Sizheng
Chadwick, Laura
Mysler, Eduardo
Moots, Robert J.
Review of Biosimilar Trials and Data on Adalimumab in Rheumatoid Arthritis
title Review of Biosimilar Trials and Data on Adalimumab in Rheumatoid Arthritis
title_full Review of Biosimilar Trials and Data on Adalimumab in Rheumatoid Arthritis
title_fullStr Review of Biosimilar Trials and Data on Adalimumab in Rheumatoid Arthritis
title_full_unstemmed Review of Biosimilar Trials and Data on Adalimumab in Rheumatoid Arthritis
title_short Review of Biosimilar Trials and Data on Adalimumab in Rheumatoid Arthritis
title_sort review of biosimilar trials and data on adalimumab in rheumatoid arthritis
topic Biosimilars (E Mysler, Section Editor)
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6097048/
https://www.ncbi.nlm.nih.gov/pubmed/30094742
http://dx.doi.org/10.1007/s11926-018-0769-6
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