Toward Regulatory Convergence and Streamlined Biosimilar Development: Recommendations from an International Qualitative Study
The consensus-based recommendations identified in this study outline priority areas and measures for streamlining biosimilar development and fostering regulatory convergence.
Authors
- Liese Barbier (ORCID: https://orcid.org/0000-0003-1786-2080)
- Arnold G. Vulto (ORCID: https://orcid.org/0000-0002-8439-2800)
- Steven Simoens (ORCID: https://orcid.org/0000-0002-9512-2005)
- Elif Car (ORCID: https://orcid.org/0000-0003-4356-4722)
- Isabelle Huys (ORCID: https://orcid.org/0000-0002-4738-8298)
- Ingrid Schwarzenberger
Institutions
- Erasmus MC (NL)
- Krankenhaus Brixen (IT)
- Erasmus University Rotterdam (NL)
- KU Leuven (BE)
Publication Details
- Journal
- BioDrugs
- Published
- 2025-10-21
- DOI
- https://doi.org/10.1007/s40259-025-00746-w
- Primary Topic
- Biosimilars and Bioanalytical Methods
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- KU Leuven