Innovative Design and Analysis for PK/PD Biosimilar Bridging Studies with Multiple References

Area of Science:

• Pharmacokinetics and Pharmacodynamics
• Biostatistics
• Regulatory Science

Background:

• Biosimilar regulatory submissions often require bridging clinical data between regions when multiple reference products exist.
• Pharmacokinetic/pharmacodynamic (PK/PD) bridging studies are crucial for leveraging existing clinical data and avoiding redundant trials.
• Ethnic considerations between regions are important for the validity of bridging studies.

Purpose of the Study:

• To propose innovative statistical designs for PK/PD biosimilar bridging studies.
• To investigate statistical models and methods applicable to these novel designs.
• To provide power analysis for sample size determination using established procedures.

Main Methods:

• Development of novel statistical designs for PK/PD biosimilar bridging studies.
• Application of statistical modeling and methods to the proposed designs.
• Power analysis using Schuirmann's two one-sided tests procedure.
• Comparative analysis with pairwise testing via simulation.

Main Results:

• Proposed innovative statistical designs for PK/PD biosimilar bridging studies.
• Statistical models and methods evaluated for the proposed designs.
• Power analysis derived and compared to existing methods through simulation.

Conclusions:

• The proposed statistical designs offer innovative approaches for PK/PD biosimilar bridging studies.
• The study provides a framework for statistical modeling and power analysis in this context.
• These methods support efficient biosimilar regulatory submissions by bridging clinical data across regions.