Hospital Pharmacy Department, Getafe University Hospital, Getafe, Madrid, Spain.
Hospital Pharmacy Department, Canary Islands University Complex, Las Palmas de Gran Canaria, Spain.
Expert Opin Biol Ther. 2024 Jul;24(7):647-653. doi: 10.1080/14712598.2024.2350440. Epub 2024 May 14.
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.
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.
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.
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.
生物制剂的出现是治疗免疫介导的炎症性疾病（IMIDs）的重大突破。然而，其高昂的成本突显了优化治疗效率的策略的必要性。生物类似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类似药的可用性对 IMIDs 生物治疗的影响。
在西班牙的 15 家医院进行了一项回顾性观察性研究，分析了开始使用生物制剂（英夫利昔单抗、依那西普、阿达木单抗）治疗的 IMID 患者（关节炎、炎症性肠病和银屑病）。评估了生物治疗的可及性和开始时间。
共纳入 267 例患者，其中 58.4% 开始使用生物类似药。生物制剂在医院的平均可及时间为 15.9±6.7 个月（原研药为 20.0±12.4 个月，生物类似药为 11.8±5.2 个月）。生物治疗的平均时间为 7.7±9.0 年（原研药为 8.6±8.9 年，生物类似药为 7.0±9.0 年）。不同疾病之间存在统计学显著差异。
生物类似药的出现增强了市场竞争，并加速了其对原研参考药物的采用，从而显著改善了 IMIDs 患者获得生物治疗的机会。与原研药相比，生物类似药的可及时间缩短了 1.6 年。
