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Scientific considerations for assessing biosimilar products.

Publication ,  Journal Article
Chow, S-C; Wang, J; Endrenyi, L; Lachenbruch, PA
Published in: Stat Med
February 10, 2013

The problem for assessing biosimilarity and drug interchangeability of follow-on biologics (biosimilar products) is studied. Unlike the generic products, the development of biosimilar products is much more complicated because of fundamental differences in functional structures and manufacturing processes. As a result, the criteria and standard methods for the design and analysis of bioequivalence assessment of generic drug products may not be directly applicable to assessing biosimilarity of biosimilar products. In this article, we provide some scientific considerations for criteria, design, and analysis regarding the assessment of biosimilarity and drug interchangeability of biosimilar products. In addition, we discuss scientific and practical issues raised at the 2010 FDA public hearing and the 2011 FDA public meeting on biosimilar products.

Duke Scholars

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Published In

Stat Med

DOI

EISSN

1097-0258

Publication Date

February 10, 2013

Volume

32

Issue

3

Start / End Page

370 / 381

Location

England

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Statistics & Probability
  • Government Regulation
  • Drug Evaluation
  • Drug Approval
  • Biosimilar Pharmaceuticals
  • Algorithms
  • 4905 Statistics
  • 4202 Epidemiology
 

Citation

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Chow, S.-C., Wang, J., Endrenyi, L., & Lachenbruch, P. A. (2013). Scientific considerations for assessing biosimilar products. Stat Med, 32(3), 370–381. https://doi.org/10.1002/sim.5571
Chow, Shein-Chung, Jun Wang, Laszlo Endrenyi, and Peter A. Lachenbruch. “Scientific considerations for assessing biosimilar products.Stat Med 32, no. 3 (February 10, 2013): 370–81. https://doi.org/10.1002/sim.5571.
Chow S-C, Wang J, Endrenyi L, Lachenbruch PA. Scientific considerations for assessing biosimilar products. Stat Med. 2013 Feb 10;32(3):370–81.
Chow, Shein-Chung, et al. “Scientific considerations for assessing biosimilar products.Stat Med, vol. 32, no. 3, Feb. 2013, pp. 370–81. Pubmed, doi:10.1002/sim.5571.
Chow S-C, Wang J, Endrenyi L, Lachenbruch PA. Scientific considerations for assessing biosimilar products. Stat Med. 2013 Feb 10;32(3):370–381.
Journal cover image

Published In

Stat Med

DOI

EISSN

1097-0258

Publication Date

February 10, 2013

Volume

32

Issue

3

Start / End Page

370 / 381

Location

England

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Statistics & Probability
  • Government Regulation
  • Drug Evaluation
  • Drug Approval
  • Biosimilar Pharmaceuticals
  • Algorithms
  • 4905 Statistics
  • 4202 Epidemiology