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Published on: December 1, 2020
The use of pharmacometrics to optimize biosimilar development
Mike Dodds1, Vincent Chow, Richard Markus
1Pharmacokinetics & Drug Metabolism, Amgen Inc., Seattle, Washington, 98119.
Journal of Pharmaceutical Sciences
|September 13, 2013
Summary
Pharmacometrics aids biosimilar development by using originator data for targeted clinical studies. This model-based approach supports the central comparability required for biosimilar approval.
Area of Science:
- Pharmacometrics
- Biosimilar Development
- Quantitative Pharmacology
Background:
- Biosimilar development requires demonstrating similarity to an originator biologic.
- Quantitative knowledge of originator product characteristics is crucial.
- Existing data on dose-exposure and exposure-response inform biosimilar strategies.
Purpose of the Study:
- To detail opportunities for pharmacometric approaches in biosimilar study design and analysis.
- To support a targeted approach to clinical studies for biosimilars.
- To leverage quantitative knowledge for biosimilar regulatory approval.
Main Methods:
- Model-based approaches to test biosimilar PK/PD profile similarity.
- Leveraging originator dose-exposure and exposure-response data.
- Application of quantitative knowledge to support biosimilar comparability.
Main Results:
- Pharmacometrics offers a quantitative framework for biosimilar development.
- Model-based methods align with central comparability requirements.
- Identified key opportunities in study design and analysis.
Conclusions:
- Pharmacometric approaches are valuable tools in biosimilar development.
- Quantitative modeling supports targeted clinical studies and regulatory approval.
- Strategic application of pharmacometrics enhances the efficiency of biosimilar evaluation.
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