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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
Comments on the FDA draft guidance on biosimilar products
Shein-Chung Chow1, Laszlo Endrenyi, Peter A Lachenbruch
1Duke University School of Medicine, Durham, NC, U.S.A.
Statistics in Medicine
|August 21, 2012
Summary
This paper discusses the US FDA
Area of Science:
- Biopharmaceutical science
- Regulatory science
- Drug development
Background:
- The US Food and Drug Administration (FDA) released draft guidance in 2012 for demonstrating biosimilarity.
- One guidance focuses on scientific considerations for biosimilarity assessment.
- Current guidance suggests a stepwise approach and totality of evidence evaluation.
Purpose of the Study:
- To provide comments on unresolved scientific issues in the FDA's draft biosimilarity guidance.
- To address key questions regarding the definition and assessment of biosimilarity.
- To offer insights for revising the scientific considerations for biosimilarity demonstration.
Main Methods:
- Analysis of the FDA's draft guidance on scientific considerations for biosimilarity.
- Identification and discussion of unanswered scientific questions and challenges.
- Review of criteria for assessing biosimilarity, study designs, and statistical methods.
Main Results:
- The guidance suggests a stepwise approach and totality of evidence for biosimilarity.
- Several critical scientific issues remain unresolved, including defining 'highly similar'.
- Further clarification is needed on study design, sample size, statistical analysis, and interchangeability assessment.
Conclusions:
- The comments aim to assist in refining the FDA's guidance documents on biosimilarity.
- Addressing these scientific issues is crucial for robust biosimilarity evaluations.
- Improved guidance will facilitate the development and approval of biosimilars.
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