Comments on the FDA draft guidance on biosimilar products.

Journal Article (Journal Article)

The Food and Drug Administration issued on February 9, 2012, drafts of three new guidance documents about the demonstration of biosimilarity. One of these deals with scientific considerations. It suggests, among others, that demonstration of biosimilarity be developed by a stepwise (step-by-step) approach and that it be assessed by considering the totality of the evidence. This communication provides comments on some scientific factors and issues that still remain unanswered or unsolved. They include the question 'how similar is considered to be highly similar?' considerations of criteria for and the degree of biosimilarity; alternatives of study design and sample size requirements; statistical methods for achieving the totality of the evidence needed for biosimilarity; and methods needed for the assessment of drug interchangeability. It is anticipated that the comments will assist the revision of the guidance documents.

Full Text

Duke Authors

Cited Authors

  • Chow, S-C; Endrenyi, L; Lachenbruch, PA

Published Date

  • February 10, 2013

Published In

Volume / Issue

  • 32 / 3

Start / End Page

  • 364 - 369

PubMed ID

  • 22903309

Electronic International Standard Serial Number (EISSN)

  • 1097-0258

Digital Object Identifier (DOI)

  • 10.1002/sim.5572


  • eng

Conference Location

  • England