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Pharmaceutical Research

, Volume 13, Issue 10, pp 1427–1437 | Cite as

Design of Biological Equivalence Programs for Therapeutic Biotechnology Products in Clinical Development: A Perspective

  • Joyce Mordenti
  • Joy A. Cavagnaro
  • James D. Green
Commentary

Abstract

The determination of biological equivalence requires that studies are conducted to establish that two molecules, two formulations, or two dosing regimens, for example, are indistinguishable with respect to safety and efficacy profiles that have been previously established. The criteria that are used to establish biological equivalence will depend on the nature of the change (e.g., molecular, process, formulation), the stage of the development program, the duration of treatment, and the intended clinical indications. Key components of an equivalence program include chemical characterization, in vitro and in vivo bioactivity against reference material, pharmacokinetics, and safety. Special considerations for patient populations, endogenous concentrations, environmental factors, immunogenicity, assay methodology, biochemical identity, pharmacodynamic equivalence, and statistical methodology are discussed. In addition, the role of preclinical in vivo assessments is addressed. Specific case studies provide insight into the varied nature of approaches that are currently employed.

bioequivalence biotechnology products recombinant proteins pharmacokinetics pharmacodynamics efficacy immunogenicity safety 

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Copyright information

© Plenum Publishing Corporation 1996

Authors and Affiliations

  • Joyce Mordenti
    • 1
  • Joy A. Cavagnaro
    • 2
  • James D. Green
    • 1
  1. 1.Experimental TherapeuticsGenentech, IncorporatedSouth San Francisco
  2. 2.United States Food and Drug AdministrationCenter for Biologies Evaluation and Research, HFM-5Rockville

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