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Aug 29, 2023
Regulatory Affairs
Quick overview of biosimilar registration in Singapore
What is a biosimilar?
A biosimilar product is a biological therapeutic product demonstrated to be similar, in physicochemical characteristics, biological activity, safety and efficacy to an existing registered biological product. The development of a biosimilar product places emphasis on the characterization of the reference’s Quality Target Product Profile and performing comparability and safety studies to demonstrate safety, quality and efficacy.
Pre-requisites of qualifying for registration of biosimilar in Singapore
- Singapore Reference Biological Product (SRBP) must be currently registered in Singapore and has the same manufacturing source. If the manufacturing source differs, bridging study is required to be performed which might include data from analytical studies (e.g. structural and functional data) that compare the proposed biosimilar product, the SRBP and the reference product used in the comparability studies, and may also include clinical PK and/or PD bridging studies data for all three products.
- Product must be approved in: EU EMA, Australia TGA, UK MHRA, US FDA and Health Canada.
- Where there is more than one indication, the efficacy and safety of the biosimilar product must be justified, or demonstrated separately for each of the claimed indications
Quick registration checklist
- Registration category
- NDA-2 :For the first strength of a biosimilar product with the same dosage form, route of administration and presentation as the Singapore reference biological product (SRBP)
- NDA-3 for subsequent strength of the biosimilar product.
- Evaluation route:
- Abridged route: Approved by at least one drug regulatory agency defined by WHO
- Verification route: Approved by at least two reference drug regulatory agencies with similar indication, dosing regimen, patient group, or directions for use.
- Administrative requirements:
- A valid CPP ,GMP certificate for both DS and DP issued from PIC/s member countries, Proposed Labelling, Patent Declaration, World wide registration status, Declaration of rejection, withdrawal, and deferral .
- Assessment by reference agencies and Official letter declaring that all aspects of the product’s quality intended for sale in Singapore are identical to that currently approved by the primary reference drug regulatory agency.
- CMC requirements:
- Complete 3.2.S and 3.2.P including comparability studies . Comparability studies should include: series of physicochemical tests, along or in combination with such biological tests as in vitro and in vivo bioassays, and receptor binding studies based on QTP established on SBRP with focus on molecular characteristics and quality attributes.
- Non-clinical documents: Complete non-clinical module including comparability studies that covers in vitro studies- to establish comparability in reactivity and likely causative factor and animal studies -investigate PD activities relevant to the clinical application and non-clinical toxicity.
- Clinical documents: Complete clinical module including comparability studies.
- The comparability studies should begin with PK and PD studies . PK studies focus on key PK parameters and for PD Studies- PD markers should be selected based on their clinical relevance.
- For comparative clinical studies, clinical comparability margins should be prespecified and adequately justified. The most sensitive clinical model should be used to detect potential differences between the biosimilar product and the SRBP.
- Risk Management Plan
If you require any pre-analysis for your biosimilar product, please feel free to get in touch or check out other relevant articles for a quick read:
https://theregconsultants.com/whatisaaseanctd/
If you have any specific regulatory questions pertaining to entering the Singapore market or require assistance with pharma regulatory services and medical product registration, feel free to reach out. Your success in the pharmaceutical industry starts with us!