Journal
FUTURE ONCOLOGY
Volume 14, Issue 24, Pages 2507-2520Publisher
FUTURE MEDICINE LTD
DOI: 10.2217/fon-2018-0051
Keywords
ABP 215; bevacizumab; biosimilar; extrapolation; metastatic colorectal cancer; non-small-cell lung cancer; PF-06439535; totality of evidence
Categories
Funding
- Acerta Pharma
- Agenus
- Celldex Therapeutics
- EMD Serono
- Incyte
- Inovio
- Midatech
- Tragara
- Biocept
- Paradigm
- Pfizer, Inc.
Ask authors/readers for more resources
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.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available