##  [Saudi Arabia: Guideline on Requirements for Biosimilar Development & Approval](/index%2ephp/mandate/saudi-arabia-guideline-on-requirements-for-biosimilar-development-approval) 

November 10, 2025

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.



[Consult Now](/webform/consult?url=https://preprod.freyrsolutions.com/index%2ephp/mandate/saudi-arabia-guideline-on-requirements-for-biosimilar-development-approval)



Source

<https://istitlaa.ncc.gov.sa/ar/health/sfda/rsrdab/Documents/RSRDAB.pdf>

<https://istitlaa.ncc.gov.sa/ar/health/sfda/RSRDAB/Pages/default.aspx>

<https://www.sfda.gov.sa/ar/news/4995502>

 

 

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