生物类似药:从生产到患者
Maria Sheridan1,2,3,4, Matthew Massich1,2,3,4, Nazanin Ashourian1,2,3,4
1Fresenius Kabi USA, LLC, Lake Zurich, Illinois.
概括
生物类药物为参考生物药物提供了安全有效的替代品,增加了患者的获取和降低了医疗保健成本. 增加处方医生和患者的知识对于更广泛的采用和最大化益处至关重要.
科学领域:
- 生物技术和制药科学 生物技术和制药科学
- 药物经济学 药物经济学
- 临床药理学 临床药理学
背景情况:
- 生物药物是通过生物技术生产的复杂分子.
- 生物类似药与批准的参考生物药物非常相似,在安全性,纯度或疗效方面没有临床意义上的差异.
- 美国FDA于2009年为生物仿制药建立了一个缩短的批准途径 (351[k]) .
研究的目的:
- 审查支持生物类似药物的安全性和有效性的证据.
- 讨论生物仿制药对患者获取和医疗保健成本的影响.
- 强调医疗保健专业人员和患者对生物类似药的教育的重要性.
主要方法:
- 审查现有的临床试验数据和生物类似药物切换现实世界的证据.
- 对生物类似药节省成本的经济预测的分析.
- 讨论影响生物类似药的采用因素,包括处方者信心和患者教育.
主要成果:
- 强有力的证据表明,转换为生物仿制药不会影响治疗的有效性或增加不良事件.
- 美国生物类似药的使用量正在上升,预计在2020-2024年间节省1040亿美元的成本.
- 需要提高医疗保健专业人员和患者的知识,以提高生物类似药的接受度.
结论:
- 生物仿制药为降低医疗保健成本和扩大生物疗法获取机会提供了宝贵的机会.
- 处方者信心和患者教育对于克服nocebo效应和确保生物类似药物成功整合至关重要.
- 输液护士在患者教育和改善生物类似药的临床结果方面发挥着关键作用.
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