The European Medicines Agency (EMA) published a draft concept paper on 24 April 2026, proposing a new guideline to establish requirements for demonstrating biosimilarity of biological veterinary medicinal products (VMPs). The initiative aims to fill a regulatory gap, as no specific guidance currently exists for veterinary biosimilars, unlike for non-biological VMPs where bioequivalence studies are standard. The document is open for public consultation until 31 July 2026, with a draft guideline expected by the third quarter of 2027.
Document scope and regulatory context
The concept paper, issued by EMA's Committee for Medicinal Products for Veterinary Use (CVMP), addresses the hybrid approach under Article 19 of Regulation (EU) 2019/6. Biological active substances are more complex than small-molecule drugs, and differences in raw materials or manufacturing processes can affect safety and efficacy. The future guideline will require a comprehensive comparability review covering quality, safety, and efficacy, including choice of reference product, stepwise biosimilarity principles, quality considerations (analytical techniques, manufacturing), and nonclinical/clinical data requirements.
Policy orientations and trade-offs
The proposed guideline seeks to balance regulatory clarity with flexibility. By establishing clear data requirements, it aims to facilitate the development and authorisation of veterinary biosimilars, potentially increasing competition and lowering prices for animal health products. However, the comprehensive comparability review may impose higher development costs on manufacturers compared to traditional generics, potentially limiting market entry for smaller firms. The guideline also emphasises a case-by-case approach, allowing regulators to tailor requirements based on the complexity of the biological product.
Impact on stakeholders
- Veterinary pharmaceutical industry: The guideline will provide much-needed regulatory clarity, reducing uncertainty for companies developing biosimilars. However, the extensive data requirements may increase R&D costs and time to market, particularly for smaller firms. - EU regulatory authorities: National competent authorities and EMA will benefit from harmonised assessment criteria, streamlining the evaluation process. However, the case-by-case approach may require additional expertise and resources. - Veterinarians and animal owners: Increased availability of biosimilars could lead to more affordable treatment options for animals, improving access to biological therapies. - EU taxpayers and public health: Potential cost savings from biosimilar competition could reduce public spending on veterinary medicines, though the impact is likely moderate given the smaller market compared to human medicines.
Expected institutional follow-up
Following the public consultation, EMA will analyse comments and develop a draft guideline, expected by Q3 2027. The final guideline will be adopted by the CVMP and published on EMA's website. Stakeholders are encouraged to submit comments by 31 July 2026.
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