Saudi Arabia · Saudi Food and Drug Authority · Biosimilars
Review target
-
Not published
Legal time limit
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Not published
Steps
7
8 requirements
Application fee
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A biosimilar is a biological product highly similar to a reference product already approved by the SFDA or a stringent regulatory authority. The applicant shows similarity in a step by step comparison focused on quality. Since July 2026 the agency can waive the comparative efficacy study when the quality data are strong, and it considers approved biosimilars interchangeable. Biological products copied from an originator biologic after patent and exclusivity expiry. The first biosimilar of an originator can ask for priority review.
1. Apply online and pay the fee; 2. Business validation; 3. Complete the file (clock stopped); 4. Biosimilarity assessment; 5. Answer questions (clock stopped); 6. Pricing; 7. Registration Committee decision.
Outcome: Marketing authorization issued through the SDR system. It is renewed every five years. Valid for 5 years.
Legal basis: Law of Pharmaceutical and Herbal Establishments and Products and its Implementing Regulations; Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and their Products
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 60 days end to end with the official step targets, of which up to 90 days are clock stops (time the applicant uses to answer). Targets, not actual times.
In order, with the official target for each step
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Saudi Arabia: Priority review. See all routes on the Saudi Arabia page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (20 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
What the applicant must provide or meet