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Era of biosimilars in rheumatology: reshaping the healthcare environment
Compared with the original approved biological drug on which it is based, a biosimilar has highly similar physicochemical characteristics and biological activity, as well as equivalent efficacy and no clinically meaningful differences in safety and immunogenicity. Before they are approved, biosimila...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6560670/ https://www.ncbi.nlm.nih.gov/pubmed/31245050 http://dx.doi.org/10.1136/rmdopen-2019-000900 |
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author | Smolen, Josef S Goncalves, Joao Quinn, Mark Benedetti, Fabrizio Lee, Jake Yongkwon |
author_facet | Smolen, Josef S Goncalves, Joao Quinn, Mark Benedetti, Fabrizio Lee, Jake Yongkwon |
author_sort | Smolen, Josef S |
collection | PubMed |
description | Compared with the original approved biological drug on which it is based, a biosimilar has highly similar physicochemical characteristics and biological activity, as well as equivalent efficacy and no clinically meaningful differences in safety and immunogenicity. Before they are approved, biosimilars must undergo a rigorous development process using state-of-the-art technologies to establish biosimilarity to the reference biological product. After approval, biosimilars must comply with good pharmacological practices for biological drugs. Several biosimilar disease-modifying antirheumatic drugs (bsDMARDs) based on the tumour necrosis factor inhibitors adalimumab, etanercept and infliximab have been approved for use in patients with rheumatic diseases. Substantial cost savings can be made if biological-naive patients begin treatment with bsDMARDs, and patients receiving original biological DMARDs (bDMARDs) are switched to bsDMARDs. Despite the consistently similar efficacy, safety and immunogenicity of bsDMARDs relative to their respective original bDMARDs, switching from a reference bDMARD to a bsDMARD can result in nocebo responses, such as subjective increase of disease activity and pain-related adverse events. This may have a negative impact on adherence to bsDMARDs in clinical trials and clinical practice. To ensure optimal and rational integration of bsDMARDs into rheumatology practice and realise the full cost-saving efficacy of these drugs, rheumatologists must be aware that careful communication of the cost-saving efficacy and safety of bsDMARDs to their patients is the key to a successful long-term switch to bsDMARD therapy. |
format | Online Article Text |
id | pubmed-6560670 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-65606702019-06-26 Era of biosimilars in rheumatology: reshaping the healthcare environment Smolen, Josef S Goncalves, Joao Quinn, Mark Benedetti, Fabrizio Lee, Jake Yongkwon RMD Open Rheumatoid Arthritis Compared with the original approved biological drug on which it is based, a biosimilar has highly similar physicochemical characteristics and biological activity, as well as equivalent efficacy and no clinically meaningful differences in safety and immunogenicity. Before they are approved, biosimilars must undergo a rigorous development process using state-of-the-art technologies to establish biosimilarity to the reference biological product. After approval, biosimilars must comply with good pharmacological practices for biological drugs. Several biosimilar disease-modifying antirheumatic drugs (bsDMARDs) based on the tumour necrosis factor inhibitors adalimumab, etanercept and infliximab have been approved for use in patients with rheumatic diseases. Substantial cost savings can be made if biological-naive patients begin treatment with bsDMARDs, and patients receiving original biological DMARDs (bDMARDs) are switched to bsDMARDs. Despite the consistently similar efficacy, safety and immunogenicity of bsDMARDs relative to their respective original bDMARDs, switching from a reference bDMARD to a bsDMARD can result in nocebo responses, such as subjective increase of disease activity and pain-related adverse events. This may have a negative impact on adherence to bsDMARDs in clinical trials and clinical practice. To ensure optimal and rational integration of bsDMARDs into rheumatology practice and realise the full cost-saving efficacy of these drugs, rheumatologists must be aware that careful communication of the cost-saving efficacy and safety of bsDMARDs to their patients is the key to a successful long-term switch to bsDMARD therapy. BMJ Publishing Group 2019-05-21 /pmc/articles/PMC6560670/ /pubmed/31245050 http://dx.doi.org/10.1136/rmdopen-2019-000900 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Rheumatoid Arthritis Smolen, Josef S Goncalves, Joao Quinn, Mark Benedetti, Fabrizio Lee, Jake Yongkwon Era of biosimilars in rheumatology: reshaping the healthcare environment |
title | Era of biosimilars in rheumatology: reshaping the healthcare environment |
title_full | Era of biosimilars in rheumatology: reshaping the healthcare environment |
title_fullStr | Era of biosimilars in rheumatology: reshaping the healthcare environment |
title_full_unstemmed | Era of biosimilars in rheumatology: reshaping the healthcare environment |
title_short | Era of biosimilars in rheumatology: reshaping the healthcare environment |
title_sort | era of biosimilars in rheumatology: reshaping the healthcare environment |
topic | Rheumatoid Arthritis |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6560670/ https://www.ncbi.nlm.nih.gov/pubmed/31245050 http://dx.doi.org/10.1136/rmdopen-2019-000900 |
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