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Malaysia NPRA: Guidelines for Registration of Biosimilars in Malaysia

Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (13 December 2023) released an updated guidance on "Guidelines for Registration of Biosimilars in Malaysia" which details meant to assist product registration holders (PRH) on how to comply with the governing acts and regulations with Biosimilars.


The purpose of this guidance document is:

  • To introduce the concept of biosimilars

  • To outline the basic principles to be applied; and

  • To provide applicants with a user guide for the relevant scientific information, in order to substantiate the claim of similarity

A biosimilar is a biologic product that is shown to be highly similar in terms of its quality, safety and efficacy to an already registered reference product in Malaysia.


Demonstration of a high level of analytical and functional similarity between the biosimilar and RP provides the rationale for a tailored nonclinical and clinical dataset to support the application for market authorization of the biosimilar.


A full quality dossier is always required for both drug substance and drug product, and a comprehensive physicochemical and biological characterisation of the biosimilar and the RP should be conducted by the manufacturer of the biosimilar and documented in the dossier.


The manufacturer must demonstrate the consistency and robustness of the manufacturing process by implementing state-of-the-art quality control and assurance procedures, inprocess controls and process validation.


The number of RP batches required to demonstrate similarity depends on the criticality of the quality attribute(s) under investigation and the approach selected for demonstrating similarity. As part of the comparability assessment, the manufacturer should include an appropriate and scientifically supported number of batches of the RP.


Click this LINK to download and know more about the requirements for for Registration of Biosimilars in Malaysia.

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