Singapore · Health Sciences Authority · Biosimilars
Review target
180 working days
performance goal
Legal time limit
-
Not published
Steps
6
12 requirements
Application fee
SGD 17,100
Fee list updated 4 September 2026
Biosimilars are filed as new drug applications (NDA-2, with NDA-3 for further strengths), not as generics. The product must be similar to a biologic registered in Singapore and approved by at least one reference agency. Only the abridged route (target 180 working days) and the verification route (target 60 working days) are open. Vaccines and plasma-derived products cannot use this pathway. A biologic that has completed a comparability program against a biologic registered in Singapore.
The official review target is 180 working days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The evaluation fee, biosimilar nda-2, verification route is SGD 17,100 for Fee list updated 4 September 2026.
1. Online application and dossier; 2. Screening (50 days); 3. Screening questions (clock stopped); 4. Evaluation (180 days); 5. Evaluation questions (clock stopped); 6. Regulatory decision.
Yes. It relies on approvals from Australia, Canada, Switzerland, European Union, United Kingdom, United States (reference approval required, reference approval required, reference approval required, reference approval required, reference approval required, reference approval required).
Outcome: Registration in the Register of Therapeutic Products. The registration is kept by paying a yearly retention fee.
Legal basis: Health Products Act 2007; Health Products (Therapeutic Products) Regulations 2016
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 230 days end to end with the official step targets, of which up to 20 days are clock stops (time the applicant uses to answer). Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Longest clock stopofficial guidance. Time allowed to answer each screening question. | 20 working days |
| Validationperformance goal. Screening target. Time spent waiting for the applicant's answers is not counted. | 50 working days |
| First review cycleperformance goal. Working days from acceptance to the first set of evaluation questions. | 120 working days |
| Review targetperformance goal. Abridged route target. Verification route: 60 working days. Official targets, not actual times. | 180 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Evaluation fee, biosimilar NDA-2, verification routeApplication · Fee list updated 4 September 2026 | SGD 17,100 |
| Evaluation fee, biosimilar NDA-2, abridged routeApplication · Fee list updated 4 September 2026 | SGD 11,600 |
| Screening fee, biosimilar application (abridged or verification)Application · Fee list updated 4 September 2026 | SGD 610 |
Other routes in Singapore: Access Consortium work sharing. See all routes on the Singapore 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 (35 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.