Product registration for biosimilar product
Application types
NDA-2
For the first strength of a biosimilar product with the same dosage form and route of administration as the Singapore reference biological product.
NDA-3
For subsequent strengths of a biosimilar product that has been registered or submitted as an NDA-2. The product name, dosage form, indication, dosing regimen and patient population should be the same as that for the NDA-2.
Fees
- Screening fee is payable upon application submission. Evaluation fee is payable upon acceptance of application for evaluation.
- All fees are charged per NDA application submitted.
Application type |
Screening fee |
Evaluation fee NDA-2 |
Evaluation fee NDA-3 |
Biosimilar product application |
$565 |
$11,200 |
$5,665 |
Annual retention fee (per registered product) : $309
Turnaround time
Application type |
Turnaround time for all applications (in working days) |
Screening |
50 |
Biosimilar product application |
180 |
Note:
- Screening turnaround time begins from the date of receipt of application dossier.
- Evaluation turnaround time begins from the date of acceptance for evaluation.
- Turnaround time may be extended if your response to our queries is incomplete, and you are required to provide further clarification or additional information.
Payment modes