Biosimilar product application

Follow this guide to find out the documents, fees and processing time needed to complete your biosimilar product application for a therapeutic product.

Biosimilar product application overview

You may be eligible to register your therapeutic product as a biosimilar product if it is a biological therapeutic product that is similar to an existing biological product registered in Singapore (Singapore reference biological product) in terms of physicochemical characteristics, biological activity, safety and efficacy. Please refer to the FAQs on Biosimilars302 KB.

Similarity to the Singapore reference biological product (SRBP) needs to be established using a comprehensive comparability exercise based on:

  • Quality characteristics
  • Biological activity
  • Safety
  • Efficacy

Search our Register of Therapeutic Products to identify the SRBP.

A biosimilar product application must be submitted as a NDA via the abridged route. There are two types of applications for biosimilar products:

  • 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.

Eligibility

Your product should fulfil the following criteria in order to qualify as a biosimilar product:

  • Comprehensive comparability exercise done with SRBP. A registered biosimilar product cannot be used as a reference product. A biological product with no suitable SRBP will not qualify for registration as a biosimilar product in Singapore.
  • If the comparative studies are performed with a reference biological product from a non-Singapore registered manufacturing source, additional bridging studies may be required to demonstrate that the reference biological product is comparable to the SRBP.
  • The active substances of the biosimilar product and the SRBP should be similar in molecular and biological terms.
  • The pharmaceutical form, strength and route of administration of the biosimilar product should be the same as the SRBP. Any differences will have to be justified by appropriate studies.
  • The conditions of use for the biosimilar product must fall within the directions for use (including indications, dosing regimens and patient groups) of the SRBP.
  • The product must be approved by at least one of the following reference drug regulatory agencies: EU EMA, Australia TGA, UK MHRA, US FDA and Health Canada. If not, you need to submit the application for a new biological product with the complete dataset.

You are encouraged to contact us for a pre-submission consultation to discuss the submission and documentary requirements before submitting a biosimilar product application.

Submission requirements

Application dossier requirements

You must submit the application dossier within 2 working days of the PRISM application and organise it in either an International Council for Harmonisation (ICH) Common Technical Document (CTD) or ASEAN CTD (ACTD) format. You need to submit all documents in English.

All administrative documents under Module 1 (ICH CTD) or Part I (ACTD) must be submitted in soft copy in PRISM.

The other parts of the ICH CTD or ACTD may be submitted online via PRISM or in a CD/DVD labelled with the following information:

  • PRISM application number.

  • PRISM submission date.

  • Product name.

  • Application type.

  • Contents of the CD/DVD (e.g. Module 2 and 5).

Note: Select ‘Biological Drug’ under product type and 'abridged' under dossier type in PRISM.

Documents Location in ICH CTD Location in ACTD Required for biosimilar products application
Administrative documents and product information Module 1 Part I Yes
Common technical document overview and summaries Module 2 Incorporated into Parts II, III and IV Yes
Quality documents Module 3 Part II Complete quality module including comparability studies
Non-clinical documents Module 4 Part III Complete non-clinical module with relevant comparability studies
Clinical documents Module 5 Part IV Complete clinical module with relevant clinical comparability studies

Documents required

You need to submit the full information on the chemical/biological development, pharmaceutical/genetic development, toxicological, pharmacological and clinical data.

Note: The amount of non-clinical and clinical data required depends on:

  • Product or class of products.
  • The extent of characterisation, which is possible to undertake when using state-of-the-art analytical methods.
  • Observed or potential differences between the biosimilar product and the reference biological product.
  • Clinical experience with the product class.

If the SRBP has more than one indication, the efficacy and safety of the biosimilar product has to be justified or demonstrated separately for each of the claimed indications, if necessary. Scientific justification must be provided in cases where it may be possible to extrapolate therapeutic similarity shown in one indication to other indications of the SRBP.

Submission of risk management plans (RMP) in support of all biosimilar applications is mandatory. Refer to the Guideline on the Submission of Risk Management Plan Documents166 KB for more details.

We may also require you to submit a periodic benefit-risk evaluation report (PBRER) relating to the product should significant safety concerns be identified during pre- and post-marketing of the product.

CTD checklists

Each application must be accompanied by a checklist, completed by the applicant and attached in PRISM.

Use one of the following application checklists for your choice of CTD. Each checklist provides details on the specific documents that need to be submitted with your application. Submit the completed checklist together with your application dossier for application screening.

Note: Your choice of CTD submitted for NDA will determine the submission format for the rest of your product life cycle. This means that future applications for changes to your registered product (variation application) will have to be in the same CTD format chosen here.

Fees and processing time

Refer to therapeutic product fees and turn-around-time for more information.

How to apply

Submit your application through PRISM. Ensure you have the following before you access the e-service:

If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).

Refer to our Guideline on PRISM Submission2051 KB for more details on how to submit.

More details on submission requirements may be found in our Guidance on Therapeutic Products Registration

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