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Bevacizumab biosimilars: scientific justification for extrapolation of indications.

Publication ,  Journal Article
Melosky, B; Reardon, DA; Nixon, AB; Subramanian, J; Bair, AH; Jacobs, I
Published in: Future Oncol
October 2018

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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Published In

Future Oncol

DOI

EISSN

1744-8301

Publication Date

October 2018

Volume

14

Issue

24

Start / End Page

2507 / 2520

Location

England

Related Subject Headings

  • United States
  • Oncology & Carcinogenesis
  • Neoplasms
  • Humans
  • Drug Approval
  • Biosimilar Pharmaceuticals
  • Bevacizumab
  • Antineoplastic Agents, Immunological
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
 

Citation

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ICMJE
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Melosky, B., Reardon, D. A., Nixon, A. B., Subramanian, J., Bair, A. H., & Jacobs, I. (2018). Bevacizumab biosimilars: scientific justification for extrapolation of indications. Future Oncol, 14(24), 2507–2520. https://doi.org/10.2217/fon-2018-0051
Melosky, Barbara, David A. Reardon, Andrew B. Nixon, Janakiraman Subramanian, Angel H. Bair, and Ira Jacobs. “Bevacizumab biosimilars: scientific justification for extrapolation of indications.Future Oncol 14, no. 24 (October 2018): 2507–20. https://doi.org/10.2217/fon-2018-0051.
Melosky B, Reardon DA, Nixon AB, Subramanian J, Bair AH, Jacobs I. Bevacizumab biosimilars: scientific justification for extrapolation of indications. Future Oncol. 2018 Oct;14(24):2507–20.
Melosky, Barbara, et al. “Bevacizumab biosimilars: scientific justification for extrapolation of indications.Future Oncol, vol. 14, no. 24, Oct. 2018, pp. 2507–20. Pubmed, doi:10.2217/fon-2018-0051.
Melosky B, Reardon DA, Nixon AB, Subramanian J, Bair AH, Jacobs I. Bevacizumab biosimilars: scientific justification for extrapolation of indications. Future Oncol. 2018 Oct;14(24):2507–2520.
Journal cover image

Published In

Future Oncol

DOI

EISSN

1744-8301

Publication Date

October 2018

Volume

14

Issue

24

Start / End Page

2507 / 2520

Location

England

Related Subject Headings

  • United States
  • Oncology & Carcinogenesis
  • Neoplasms
  • Humans
  • Drug Approval
  • Biosimilar Pharmaceuticals
  • Bevacizumab
  • Antineoplastic Agents, Immunological
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis