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Regulatory Requirements for Interchangeable Biosimilar Designation
Praveen J Samy1, Morgane C Mouslim2,3, Charles L Bennett4
1Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Therapeutic Innovation & Regulatory Science
|November 16, 2025
Summary
The US Food and Drug Administration (FDA) has approved 26 interchangeable biosimilars since 2020, with recent approvals accelerating. New FDA guidance may further streamline the process, potentially reducing costs and increasing biosimilar adoption.
Area of Science:
- Pharmaceutical Sciences
- Regulatory Science
- Health Economics
Background:
- The US Food and Drug Administration (FDA) initially required extensive phase III clinical trials for interchangeable biosimilar designation.
- Recent draft guidance (June 2024) shifts focus from clinical to analytical data, potentially altering approval pathways.
Purpose of the Study:
- To analyze trends in US interchangeable biosimilar approvals from 2019 to 2025.
- To examine manufacturer strategies and regulatory timelines for interchangeable biosimilars.
- To assess the impact of evolving FDA guidance on biosimilar development.
Main Methods:
- Utilized the FDA Purple Book archive (as of September 2025) to identify interchangeable biosimilars and related data.
- Analyzed approval trends by year, manufacturer, product class, and submission strategy.
- Calculated average regulatory approval timelines based on FDA submission and approval dates.
Main Results:
- 26 interchangeable biosimilars approved since 2020; 19 approved between January 2024 and September 2025.
- Adalimumab biosimilars represent a significant portion (6 approvals).
- Average approval timelines decreased significantly, from 798 days (2020) to 364 days (2024).
- Concurrent submission for interchangeability became the predominant strategy.
Conclusions:
- Concurrent interchangeable designation is now the primary regulatory pathway.
- The FDA's June 2024 Draft Guidance may reduce development costs and timelines by removing switching study requirements.
- These regulatory shifts, coupled with education, could boost biosimilar uptake and lower biologic drug costs.
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