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Considerations related to comparative clinical studies for biosimilars
Anurag S Rathore1, James G Stevenson2, Hemlata Chhabra1
1Department of Chemical Engineering, Indian Institute of Technology, Delhi, India.
Expert Opinion on Drug Safety
|January 18, 2021
Summary
Biosimilar medicines offer lower-cost access to biologics. Regulatory approval requires demonstrating similarity to the reference product, supported by clinical studies and totality of evidence.
Area of Science:
- Biotechnology
- Pharmacology
- Regulatory Science
Background:
- Biosimilar medicines increase access to essential treatments by offering lower-cost alternatives after originator drug patent expiration.
- Global regulatory agencies have established guidelines to streamline the approval process for biosimilars.
- Biosimilar approval relies on a comprehensive assessment demonstrating similarity to the reference biologic in quality, safety, and efficacy.
Purpose of the Study:
- To provide an overview of biosimilar regulatory guidelines.
- To discuss the significance and considerations of comparative clinical studies in biosimilar development.
- To present case studies from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
Main Methods:
- Review of existing biosimilar regulatory guidelines from major health authorities.
- Analysis of two regulatory assessment reports (EMA and FDA) for biosimilar approvals.
- Discussion of the role of pharmacokinetic and pharmacodynamic studies in regulatory decision-making.
Main Results:
- Comparative clinical studies are essential for biosimilar approval, evaluating physicochemical properties, biological activity, safety, and efficacy.
- Pharmacokinetic and pharmacodynamic studies are critical for demonstrating biosimilarity.
- Regulatory assessment reports highlight the importance of a totality of evidence approach.
Conclusions:
- Biosimilar development requires careful selection of clinical parameters, including biomarkers, endpoints, and acceptance criteria.
- Successful biosimilar approval hinges on robust data demonstrating similarity to the reference product.
- The case studies underscore the critical role of well-designed clinical trials in the regulatory pathway for biosimilars.
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