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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Biosimilars: policy, clinical, and regulatory considerations
1American Enterprise Institute for Public Policy Research, 1150 17th Street, Washington, DC 20036, USA. scott.gottlieb@mssm.edu
Summary
Biosimilars offer cost savings and public health benefits, but the U.S. lacks a formal regulatory pathway. Demonstrating interchangeability for these complex proteins requires advanced science and clinical data.
Area of Science:
- Biopharmaceutical science
- Regulatory science
- Health economics
Background:
- Biosimilars are biopharmaceuticals similar to innovator products but not necessarily interchangeable.
- The biopharmaceutical protein production process involves complex manufacturing considerations.
- Existing regulatory frameworks require adaptation for biosimilar evaluation.
Purpose of the Study:
- To describe the regulatory background of biosimilars.
- To outline scientific considerations for biosimilar policy discussions.
- To review the European Union's biosimilar system and U.S. legislation status.
Main Methods:
- Review of regulatory frameworks and scientific literature.
- Analysis of the European Union's biosimilar approval process.
- Assessment of the current state of U.S. biosimilar legislation.
Main Results:
- The U.S. lacks a formal regulatory process for biosimilars.
- Characterizing complex biopharmaceuticals and demonstrating interchangeability presents scientific challenges.
- The European Union provides a potential model for U.S. biosimilar regulation.
Conclusions:
- Abbreviated regulatory pathways for biosimilars can yield significant cost savings and public health benefits.
- Demonstrating therapeutic equivalence and interchangeability for biosimilars is complex and requires more than criteria for small-molecule drugs.
- Resolving the legal and regulatory status of biosimilars in the U.S. is crucial, involving policy decisions on manufacturing, patents, and clinical use.
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