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.

Return to DIA Statistics Forum