Demonstration of biosimilarity of biological veterinary medicinal products - Scientific guideline

This concept paper addresses the need for a guideline on data requirements for applications for marketing authorisations based on Article 19 of Regulation (EU) 2019/6 (“hybrid veterinary medicinal products”) for similar biological veterinary medicinal products.

Keywords: Biosimilar veterinary medicinal product, hybrid approach, comparability

Current version

Draft concept paper on the development for guidance on demonstration of biosimilarity of biological veterinary medicinal products

Draft: consultation open Consultation dates: 24/04/2026 to 31/07/2026 Reference Number: EMA/CVMP/121133/2025 Summary:

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