Medical Oncology, British Columbia Cancer Agency, University of British Columbia, Vancouver, BC V5Z 4E6, Canada.
Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA 02215, USA.
Future Oncol. 2018 Oct;14(24):2507-2520. doi: 10.2217/fon-2018-0051. Epub 2018 Apr 25.
The first biosimilar of bevacizumab was approved by the US FDA; other potential biosimilars of bevacizumab are in late-stage clinical development. Their availability offers opportunity for increased patient access across a number of oncologic indications. The regulatory pathway for biosimilar approval relies on the totality of evidence that includes a comprehensive analytical assessment, and a clinical comparability study in a relevant disease patient population. Extrapolation of indications for a biosimilar to other eligible indications held by the originator, in the absence of direct clinical comparison, frequently forms part of the regulatory judgment. Herein, we consider the evidence required to demonstrate biosimilarity for bevacizumab biosimilars, with particular focus on the rationale for extrapolation across oncologic indications.
首个贝伐珠单抗生物类似药获得美国 FDA 批准；其他潜在的贝伐珠单抗生物类似药处于临床开发后期。这些生物类似药的出现为许多肿瘤适应证的更多患者带来了获益机会。生物类似药批准的监管途径依赖于包括全面分析评估和在相关疾病患者人群中进行临床可比性研究的综合证据。在缺乏直接临床比较的情况下，将生物类似药的适应证外推至原研药的其他合格适应证，通常是监管判断的一部分。在此，我们考虑了证明贝伐珠单抗生物类似药相似性所需的证据，特别关注跨肿瘤适应证外推的基本原理。
