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Published on: May 4, 2017
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Biosimilars: Key regulatory considerations and similarity assessment tools
Carol F Kirchhoff1, Xiao-Zhuo Michelle Wang2, Hugh D Conlon3
1Pfizer Inc, Global Technology Services, Biotechnology and Aseptic Sciences Group, Chesterfield, Missouri.
Biotechnology and Bioengineering
|August 27, 2017
Summary
Developing biosimilar drugs requires rigorous comparison to reference products, involving extensive characterization and clinical studies. Overcoming regulatory hurdles and demonstrating no clinically meaningful differences are key challenges for pharmaceutical companies.
Area of Science:
- Biopharmaceutical development
- Regulatory science
Background:
- Biosimilar drugs are highly similar to reference biologic products with no clinically meaningful differences.
- The development and approval of biosimilars are complex and highly regulated processes globally.
Purpose of the Study:
- To discuss the challenges pharmaceutical companies face in developing biosimilar drugs.
- To highlight the regulatory landscape and scientific evidence required for biosimilar approval.
Main Methods:
- Comprehensive structural and functional characterization of biosimilars compared to reference products.
- In vivo nonclinical evaluations and comparative clinical pharmacology studies.
- Iterative assessment of similarity throughout the development process.
Main Results:
- Demonstrating high similarity and lack of clinically meaningful differences is essential.
- Regulatory requirements for biosimilar approval vary internationally.
- Scientific evidence must support any minor differences between biosimilars and reference products.
Conclusions:
- Biosimilar development is a challenging, multistep process requiring extensive comparative analysis.
- Navigating global regulatory variations and substantiating scientific evidence are critical for successful biosimilar approval.
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