Regulatory Requirements for Interchangeable Biosimilar Designation
Concurrent interchangeable designation is now the predominant regulatory pathway. The FDA June 2024 Draft Guidance, removing switching studies requirement for interchangeability might cut biosimilar development costs and development timelines. These changes, alongside provider and patient education, could enhance biosimilar uptake and reduce biologic drug costs.
Authors
- Charles L. Bennett (ORCID: https://orcid.org/0000-0002-8645-5705)
- Morgane C. Mouslim (ORCID: https://orcid.org/0000-0002-6999-7588)
- Antonio J. Trujillo
- Praveen J. Samy
Institutions
- Johns Hopkins University (US)
- University of South Carolina (US)
- University of Michigan (US)
- University of Maryland, Baltimore County (US)
Publication Details
- Journal
- Therapeutic Innovation & Regulatory Science
- Published
- 2025-11-16
- DOI
- https://doi.org/10.1007/s43441-025-00897-6
- Citations
- 1
- Primary Topic
- Biosimilars and Bioanalytical Methods
- Type
- article
- Field-Weighted Citation Impact
- 0.80