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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 approved for hematologists: lessons from comparative efficacy studies and comparative analytical
Thomas Herndon1, Nina N Brahme1, M Stacey Ricci1
1United States Food and Drug Administration, Silver Spring, Maryland, United States.
Blood
|May 12, 2026
Summary
Hematologic biosimilars are increasingly approved, with developers now relying more on analytical data than comparative efficacy studies. This shift reflects growing confidence in analytical comparisons for demonstrating biosimilarity.
Area of Science:
- Biopharmaceuticals
- Regulatory Science
- Hematology
Background:
- Hematologic biosimilars have been central to U.S. biosimilar development since 2015, with over 80 now FDA-licensed.
- Traditionally, demonstrating biosimilarity required comparative analytical assessment (CAA) and clinical studies, including comparative efficacy studies (CES).
Purpose of the Study:
- To review FDA-approved hematologic biosimilar programs and analyze the evolving role of comparative efficacy studies (CES).
- To provide insights into the future utility of CES based on historical data and emerging regulatory recommendations.
Main Methods:
- Historical overview of FDA-approved hematologic biosimilar development programs.
- Analysis of regulatory trends and scientific consensus regarding the necessity of CES.
Main Results:
- Growing scientific confidence in comparative analytical assessment (CAA) has led regulators to reconsider the need for CES.
- Emerging global consensus indicates CAA is more sensitive than CES for predicting biosimilarity.
Conclusions:
- The role of CES in biosimilar development is evolving, with a potential reduction in requirement due to advancements in analytical methods.
- Re-examining hematologic biosimilar programs offers valuable insights into the changing landscape of biosimilarity assessment.
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