Bevacizumab biosimilars: scientific justification for extrapolation of indications.

Published

Journal Article (Review)

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.

Full Text

Duke Authors

Cited Authors

  • Melosky, B; Reardon, DA; Nixon, AB; Subramanian, J; Bair, AH; Jacobs, I

Published Date

  • October 2018

Published In

Volume / Issue

  • 14 / 24

Start / End Page

  • 2507 - 2520

PubMed ID

  • 29690784

Pubmed Central ID

  • 29690784

Electronic International Standard Serial Number (EISSN)

  • 1744-8301

Digital Object Identifier (DOI)

  • 10.2217/fon-2018-0051

Language

  • eng

Conference Location

  • England