期刊
FUTURE ONCOLOGY
卷 14, 期 24, 页码 2507-2520出版社
FUTURE MEDICINE LTD
DOI: 10.2217/fon-2018-0051
关键词
ABP 215; bevacizumab; biosimilar; extrapolation; metastatic colorectal cancer; non-small-cell lung cancer; PF-06439535; totality of evidence
类别
资金
- Acerta Pharma
- Agenus
- Celldex Therapeutics
- EMD Serono
- Incyte
- Inovio
- Midatech
- Tragara
- Biocept
- Paradigm
- Pfizer, Inc.
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.
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