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Short Course* Registration: 7:30-8:30AM

Biological drugs are much more complicated than chemically synthesized, small molecule drugs. For instance, their size is much larger and structure is more complicated. Additionally, they can be sensitive to environmental conditions such as light, temperature, or pressure. Moreover, they may expose patients to immunogenic reactions. Consequently, the assessment of biosimilarity and interchangeability calls for greater circumspection than the evaluation of bioequivalence. The FDA recommends the use of stepwise approach for obtaining totality-of-the-evidence for demonstration of biosimilarity and interchangeability. The stepwise approach involves analytical similarity assessment, animal studies for toxicity, pharmacokinetic and pharmacodynamics (PK/PD) studies for pharmacological activities, and clinical studies including immunogenicity for safety, tolerability, and efficacy. The present communication discusses some current issues and recent development related to the assessment of biosimilarity and interchangeability of biosimilar products.

Current issues include:

  1. Biosimilar versus biobetter
  2. How many biosimilar studies are required
  3. Multiple reference products
  4. Criteria for highly variable drug products
  5. Development of biosimilarity index
  6. Analytical similarity assessment for critical quality attributes
  7. Drug interchangeability in terms of switching and alternation
  8. Study designs useful for the assessment of biosimilarity and drug interchangeability
  9. Post-approval non-medical switching
  10. Extrapolation of data (both analytical and clinical) across different indications

These issues and corresponding recent developments will be discussed.

*Short Courses are not included in the forum registration and require a separate fee.

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Learning objectives

At the conclusion of this short course, participants should be able to: 

  • Develop a clear understanding regarding the concepts of biosimilarity and interchangeability for biosimilar drug development
  • Focus statistical methods including sample size requirement and data analysis for demonstrating biosimilarity and interchangeability
  • Discuss current issues and FDA’s current thinking and recommendations regarding the assessment of biosimilarity and interchangeability
  • Explain recent developments including regulatory guidance and statistical methodology development

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