Design and Analysis of a Biosimilar Bridging Study with a Prediction Interval-Based Consistency Test

Area of Science:

• Pharmaceutical Sciences
• Biostatistics
• Regulatory Science

Background:

• Biosimilar development and global regulatory strategies are expanding.
• Bridging studies are crucial for regional biosimilar market access.
• Existing statistical methods for bridging studies may not fit biosimilar global comparisons.

Purpose of the Study:

• To present a novel statistical methodology for designing and analyzing biosimilar bridging studies.
• To assess the consistency between a biosimilar bridging study and a global biosimilar study.
• To provide a practical approach for regulatory submissions of biosimilars.

Main Methods:

• Development of a prediction interval-based consistency test.
• Analytical proof of statistical properties (power and type I error control).
• Illustration with a numerical example for practical implementation.

Main Results:

• The proposed method demonstrates high power for consistent studies.
• The method effectively controls type I error for inconsistent studies.
• The methodology is applicable to various endpoints and metrics.

Conclusions:

• The novel statistical method offers a practical and robust approach for biosimilar bridging studies.
• This methodology supports the global regulatory approval of biosimilar products.
• The approach ensures scientific rigor in demonstrating biosimilarity across regions.