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Biosimilars: The US Regulatory Framework*
Annual Review of Medicine ( IF 15.1 ) Pub Date : 2017-01-18 00:00:00 , DOI: 10.1146/annurev-med-051215-031022
Leah A. Christl 1 , Janet Woodcock 1 , Steven Kozlowski 1
Affiliation  

With the passage of the Biologics Price Competition and Innovation Act of 2009, the US Food and Drug Administration established an abbreviated pathway for developing and licensing biosimilar and interchangeable biological products. The regulatory framework and the technical requirements of the US biosimilars program involve a stepwise approach that relies heavily on analytical methods to demonstrate through a “totality of the evidence” that a proposed product is biosimilar to its reference product. By integrating analytical, pharmacological, and clinical data, each of which has limitations, a high level of confidence can be reached regarding clinical performance. Although questions and concerns about the biosimilars pathway remain and may slow uptake, a robust scientific program has been put in place. With three biosimilars already licensed and numerous development programs under way, clinicians can expect to see many new biosimilars come onto the US market in the coming decade. [Note added in proof: Since the writing of this article, a fourth biosimilar has been approved.]

中文翻译:


生物仿制药:美国监管框架*

随着2009年《生物制剂价格竞争和创新法案》的通过,美国食品和药物管理局为开发和许可生物仿制药和可互换生物产品建立了一条简化的途径。美国生物仿制药计划的监管框架和技术要求涉及逐步采用的方法,该方法在很大程度上依赖于分析方法,以通过“证据总数”证明拟议产品与其参考产品具有生物仿制药。通过整合分析,药理和临床数据,每种方法都有局限性,可以在临床表现上达到很高的置信度。尽管有关生物仿制药途径的问题和担忧仍然存在,并且可能会减缓其吸收,但已经制定了强有力的科学计划。由于已经批准了三种生物仿制药,并且正在实施众多开发计划,临床医生可以期望在未来十年内看到许多新的生物仿制药进入美国市场。[注释中添加了注释:自从撰写本文以来,已经批准了第四个生物仿制药。]

更新日期:2017-01-18
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