Biosimilars in Focus: Evaluating Their Role Compared to Adalimumab in Clinical Practice
Introduction and Purpose: Adalimumab, a TNF-α inhibitor, is a cornerstone treatment for autoimmune and inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease. Despite its efficacy, the high cost of adalimumab (Humira®) limits accessibility. The emergence of biosimilars o...
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| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Nicolaus Copernicus University in Toruń
2025-01-01
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| Series: | Quality in Sport |
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| Online Access: | https://apcz.umk.pl/QS/article/view/57232 |
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| author | Dorota Waz Michał Mazur Jakub Szarłowicz Zofia Goliszek Karolina Łucja Sobek Wiktoria Tabin-Barczak Aldona Sokołowska Klaudia Fikas Kamil Chwaliszewski Sebastian Samuła |
| author_facet | Dorota Waz Michał Mazur Jakub Szarłowicz Zofia Goliszek Karolina Łucja Sobek Wiktoria Tabin-Barczak Aldona Sokołowska Klaudia Fikas Kamil Chwaliszewski Sebastian Samuła |
| author_sort | Dorota Waz |
| collection | DOAJ |
| description | Introduction and Purpose:
Adalimumab, a TNF-α inhibitor, is a cornerstone treatment for autoimmune and inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease. Despite its efficacy, the high cost of adalimumab (Humira®) limits accessibility. The emergence of biosimilars offers cost-effective alternatives with comparable efficacy, safety, and immunogenicity. This article reviews the role of adalimumab biosimilars, their clinical equivalence, and potential to address healthcare challenges.
Materials and Methods:
A comprehensive literature review was conducted to evaluate the structural, functional, and clinical parity of adalimumab biosimilars with the reference product. Key studies on pharmacokinetics, efficacy, safety, therapeutic drug monitoring (TDM), and real-world outcomes were analyzed.
Results:
Adalimumab biosimilars demonstrate equivalent pharmacokinetic profiles and clinical efficacy across conditions, with comparable remission rates and safety profiles. Innovations, such as citrate-free formulations and advanced delivery devices, enhance patient adherence. Biosimilars significantly reduce treatment costs, increasing accessibility, especially in resource-constrained settings. Challenges remain in patient acceptance and managing therapy transitions.
Conclusion:
Biosimilars are transformative in addressing the cost barrier of biologic therapies, maintaining therapeutic equivalence to adalimumab while expanding access globally. Enhanced TDM and patient-centered strategies are essential for optimizing outcomes and maximizing their adoption in clinical practice.
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| format | Article |
| id | doaj-art-84b9c5a6a5994faa9ef7fe7f473d8180 |
| institution | Kabale University |
| issn | 2450-3118 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Nicolaus Copernicus University in Toruń |
| record_format | Article |
| series | Quality in Sport |
| spelling | doaj-art-84b9c5a6a5994faa9ef7fe7f473d81802025-01-12T08:22:52ZengNicolaus Copernicus University in ToruńQuality in Sport2450-31182025-01-013710.12775/QS.2025.37.57232Biosimilars in Focus: Evaluating Their Role Compared to Adalimumab in Clinical PracticeDorota Wazhttps://orcid.org/0009-0004-7484-9231Michał Mazur0https://orcid.org/0009-0007-3840-4325Jakub Szarłowicz1https://orcid.org/0009-0006-8520-9496Zofia Goliszek2https://orcid.org/0009-0005-9881-5754Karolina Łucja Sobek3https://orcid.org/0009-0000-2551-0515Wiktoria Tabin-Barczak4https://orcid.org/0009-0003-8333-8428Aldona Sokołowska5https://orcid.org/0009-0006-8723-2593Klaudia Fikas6https://orcid.org/0009-0008-1976-2941Kamil Chwaliszewski7https://orcid.org/0009-0003-7239-3122Sebastian Samuła8https://orcid.org/0009-0008-8915-4263University of Rzeszów al. Tadeusza Rejtana 16C, 35-310 Rzeszów, PolandMedical Center in Łańcut, Poland Ignacego Paderewskiego 5, 37-100 Łańcut, PolandMedical Center in Łańcut, Poland Ignacego Paderewskiego 5, 37-100 Łańcut, PolandMedical Center in Łańcut, Poland Ignacego Paderewskiego 5, 37-100 Łańcut, PolandUniversity of Rzeszów al. Tadeusza Rejtana 16C, 35-310 Rzeszów, PolandProvincial Clinical Hospital No. 2 named after saint Jadwiga the Queen in Rzeszów, Lwowska 60, 35-301 RzeszówUniversity of Rzeszów al. Tadeusza Rejtana 16C, 35-310 Rzeszów, PolandUniversity of Rzeszów al. Tadeusza Rejtana 16C, 35-310 Rzeszów, PolandStefan Cardinal Wyszyński Provincial Specialist Hospital SPZOZ in Lublin, Aleja Kraśnicka 100, 20-718 Lublin, PolandIntroduction and Purpose: Adalimumab, a TNF-α inhibitor, is a cornerstone treatment for autoimmune and inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease. Despite its efficacy, the high cost of adalimumab (Humira®) limits accessibility. The emergence of biosimilars offers cost-effective alternatives with comparable efficacy, safety, and immunogenicity. This article reviews the role of adalimumab biosimilars, their clinical equivalence, and potential to address healthcare challenges. Materials and Methods: A comprehensive literature review was conducted to evaluate the structural, functional, and clinical parity of adalimumab biosimilars with the reference product. Key studies on pharmacokinetics, efficacy, safety, therapeutic drug monitoring (TDM), and real-world outcomes were analyzed. Results: Adalimumab biosimilars demonstrate equivalent pharmacokinetic profiles and clinical efficacy across conditions, with comparable remission rates and safety profiles. Innovations, such as citrate-free formulations and advanced delivery devices, enhance patient adherence. Biosimilars significantly reduce treatment costs, increasing accessibility, especially in resource-constrained settings. Challenges remain in patient acceptance and managing therapy transitions. Conclusion: Biosimilars are transformative in addressing the cost barrier of biologic therapies, maintaining therapeutic equivalence to adalimumab while expanding access globally. Enhanced TDM and patient-centered strategies are essential for optimizing outcomes and maximizing their adoption in clinical practice. https://apcz.umk.pl/QS/article/view/57232adalimumabbiosimilarsInflammatory Bowel Diseaseankylosing spondylitisTNF-alpha (TNF-α)Rheumatoid arthritis (RA) |
| spellingShingle | Dorota Waz Michał Mazur Jakub Szarłowicz Zofia Goliszek Karolina Łucja Sobek Wiktoria Tabin-Barczak Aldona Sokołowska Klaudia Fikas Kamil Chwaliszewski Sebastian Samuła Biosimilars in Focus: Evaluating Their Role Compared to Adalimumab in Clinical Practice Quality in Sport adalimumab biosimilars Inflammatory Bowel Disease ankylosing spondylitis TNF-alpha (TNF-α) Rheumatoid arthritis (RA) |
| title | Biosimilars in Focus: Evaluating Their Role Compared to Adalimumab in Clinical Practice |
| title_full | Biosimilars in Focus: Evaluating Their Role Compared to Adalimumab in Clinical Practice |
| title_fullStr | Biosimilars in Focus: Evaluating Their Role Compared to Adalimumab in Clinical Practice |
| title_full_unstemmed | Biosimilars in Focus: Evaluating Their Role Compared to Adalimumab in Clinical Practice |
| title_short | Biosimilars in Focus: Evaluating Their Role Compared to Adalimumab in Clinical Practice |
| title_sort | biosimilars in focus evaluating their role compared to adalimumab in clinical practice |
| topic | adalimumab biosimilars Inflammatory Bowel Disease ankylosing spondylitis TNF-alpha (TNF-α) Rheumatoid arthritis (RA) |
| url | https://apcz.umk.pl/QS/article/view/57232 |
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