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Sample size calculations for the development of biosimilar products
1a Department of Applied Statistics , Yonsei University , Seoul , Korea.
Journal of Biopharmaceutical Statistics
|July 18, 2014
Summary
The standard sample size formula for biosimilar equivalence trials is overly conservative, potentially increasing costs. Calculating sample size using exact power offers a more precise and cost-effective approach for biotechnology companies.
Area of Science:
- Biostatistics
- Pharmacoeconomics
- Drug Development
Background:
- Phase III equivalence trials are standard for demonstrating biosimilarity.
- Current sample size formulas rely on approximate power calculations.
- This can lead to inflated sample sizes and unnecessary costs.
Purpose of the Study:
- To evaluate the accuracy of the commonly used sample size formula for biosimilar equivalence trials.
- To investigate the impact of using approximate versus exact power in sample size calculations.
- To propose a more precise method for sample size determination.
Main Methods:
- Analysis of a widely used sample size formula for equivalence trials.
- Comparison of sample sizes derived from approximate and exact power calculations.
- Numerical calculation of sample size using exact power, with R code provided.
Main Results:
- The existing sample size formula is found to be overly conservative.
- Exact power can be significantly higher than the targeted power for sample sizes calculated using the approximate formula.
- This conservatism can result in substantial extra costs for biotechnology firms.
Conclusions:
- The conventional sample size formula for biosimilar equivalence trials leads to unnecessarily large sample sizes.
- Calculating sample size based on exact power provides a more accurate and cost-efficient determination.
- Adopting precise, numerical sample size calculations is recommended for future biosimilar studies.
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