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Harmonization of Regulatory Approaches for Evaluating Therapeutic Equivalence and Interchangeability of Multisource and Complex Drug Products

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Preliminary Program

Goals and Objectives

This workshop will bring together pharmaceutical scientists from industry, academia and regulatory agencies in different regions and countries to review scientific and regulatory issues in demonstrating therapeutic equivalence and interchangeability of multisource (generic) drug products, including complex drugs. Key messages from this meeting may be published for the scientific community towards a better understanding of differing regulatory approaches and important factors underlying product performance, facilitating a process of global harmonization of therapeutic equivalence requirements in the future.

The goals and objectives of this workshop are multi-fold.

  • Review scientific and regulatory approaches for demonstration of pharmaceutical equivalence and bioequivalence of multisource drug products from different regions and/or countries globally.
  • Discuss existing and emerging issues in determining equivalence of drug products, including complex drug products and dosage forms (such as low molecular weight heparins, Fe-sugar complexes, complex peptide mixtures, liposomes and nanotech-derived products).
  • Discuss the white paper on Complex Drug Products.
  • Discuss current bioequivalence criteria using pharmacokinetic measures and pharmacodynamic/clinical endpoints for various types of dosage forms, including highly variable drug products.
  • Examine the role of in vivo and/or in vitro bioequivalence studies in the approval of multisource products and the possibilities of reducing duplication of these studies for different regions, including the choice of a reference listed drug.
  • Consider current regulatory policies on waivers of in vivo bioequivalence studies, discuss available in vitro methods or tools as surrogate for bioequivalence and identify approaches to expanding waivers of in vivo bioequivalence studies.

This workshop will provide the forum for an open discussion on scientific and regulatory issues in the area of equivalence, facilitating a process for harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products.