SFDA released its updated guideline outlining Regulatory and scientific requirements for biosimilar approval. The document (originally dated 26-Oct-2025) is open for public comment until 09-Jan-2026 and details expectations for demonstrating biosimilarity to a Reference Product (RP).
Key highlights:
- Criteria for Reference Product (RP) selection
- Requirements for comparability exercises across quality, safety, efficacy, and immunogenicity
- Comparative Quality Exercise (CQE) using validated analytical methods
- Conditions when non-clinical or Comparative Efficacy Studies (CES) may be waived
- Rules for indication extrapolation with scientific justification
This update strengthens Saudi Arabia’s biosimilar evaluation and approval framework.
Source
Select Mandate HA
Select Mandate Function