生物仿制药与免疫介导疾病的生物治疗。

IF 3.6 3区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-05-14 DOI:10.1080/14712598.2024.2350440
Rocío Vázquez-Sánchez, Marco Navarro-Dávila, Esther Ramírez Herráiz, Vicente Merino-Bohórquez, Joaquín Borrás-Blasco, Alberto Onteniente-González, Ana Iglesias-Lambarri, Eva Negro-Vega
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引用次数: 0

摘要

背景:生物制剂的兴起是治疗免疫介导的炎症性疾病(IMIDs)的一大突破。然而,生物制剂的高昂成本凸显了优化治疗效率策略的必要性。生物仿制药为生物制剂提供了具有成本效益的替代品。本研究旨在评估生物仿制药的可用性对IMIDs生物疗法可及性的影响:在西班牙15家医院开展的一项回顾性观察研究分析了开始使用原研药或生物类似药(英夫利昔单抗、依那西普、阿达木单抗)进行生物治疗的IMID患者(关节病、炎症性肠病和银屑病)。结果:共纳入 267 名患者,其中 58.4% 开始使用生物仿制药。医院提供生物制剂药物的平均时间为 15.9 ± 6.7 个月(原研药为 20.0 ± 12.4 个月,生物仿制药为 11.8 ± 5.2 个月)。接受生物制剂治疗的平均时间为 7.7 ± 9.0 年(原研药为 8.6 ± 8.9 年,生物仿制药为 7.0 ± 9.0 年)。结论:生物仿制药的出现,将对人类的健康产生重大影响:结论:生物仿制药的出现加强了市场竞争,加快了医院采用生物仿制药治疗原研药的步伐。这极大地改善了IMIDs患者获得生物治疗的机会,生物类似药的使用时间明显缩短了1.6年。
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Biosimilars and access to biologic therapy in immune-mediated diseases.

Background: The rise of biologic agents has been a major breakthrough in treating immune-mediated inflammatory diseases (IMIDs). However, their high cost underscores the need for strategies to optimize treatment efficiency. Biosimilars offer cost-effective alternatives to biologics. This study aimed to assess biosimilar drug availability's impact on biologic therapy access for IMIDs.

Research design and methods: A retrospective observational study in 15 Spanish hospitals analyzed IMID patients (arthropathies, inflammatory bowel disease and psoriasis) initiating biologic therapy with originator or biosimilar drugs (infliximab, etanercept, adalimumab). Time to availability and initiation of biologic therapy were assessed.

Results: 267 patients were included, with 58.4% starting on biosimilars. The mean time to availability of the biologic drugs in the hospitals was 15.9 ± 6.7 months, (20.0 ± 12.4 for originator and 11.8 ± 5.2 for biosimilars). Mean time to biologic treatment was 7.7 ± 9.0 years (8.6 ± 8.9 for originators and 7.0 ± 9.0 for biosimilars). Showing statistically significant differences among conditions.

Conclusion: The emergence of biosimilar drugs has enhanced market competition and accelerated their adoption into hospitals' therapeutic regimens over original reference drugs. This has significantly improved access to biologic therapy for patients with IMIDs, evidenced by a notable 1.6-year reduction in access time for biosimilar drugs.

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来源期刊
Expert Opinion on Biological Therapy
Expert Opinion on Biological Therapy 医学-生物工程与应用微生物
CiteScore
8.60
自引率
0.00%
发文量
96
审稿时长
3-8 weeks
期刊介绍: Expert Opinion on Biological Therapy (1471-2598; 1744-7682) is a MEDLINE-indexed, international journal publishing peer-reviewed research across all aspects of biological therapy. Each article is structured to incorporate the author’s own expert opinion on the impact of the topic on research and clinical practice and the scope for future development. The audience consists of scientists and managers in the healthcare and biopharmaceutical industries and others closely involved in the development and application of biological therapies for the treatment of human disease. The journal welcomes: Reviews covering therapeutic antibodies and vaccines, peptides and proteins, gene therapies and gene transfer technologies, cell-based therapies and regenerative medicine Drug evaluations reviewing the clinical data on a particular biological agent Original research papers reporting the results of clinical investigations on biological agents and biotherapeutic-based studies with a strong link to clinical practice Comprehensive coverage in each review is complemented by the unique Expert Collection format and includes the following sections: Expert Opinion – a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results; Article Highlights – an executive summary of the author’s most critical points.
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