top of page

Malaysia NPRA: Guidelines for Registration of Biosimilars in Malaysia

Writer's picture: Sharan MuruganSharan Murugan

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.

Comments


I Sometimes Send Newsletters

Thanks for submitting!

  • LinkedIn
  • Facebook
  • Twitter
  • Instagram

DISCLAIMER

The views expressed in this publication do not necessarily reflect the views of any guidance of government, health authority, it's purely my understanding. This Blog/Web Site is made available by a regulatory professional, is for educational purposes only as well as to give you general information and a general understanding of the pharmaceutical regulations, and not to provide specific regulatory advice. By using this blog site you understand that there is no client relationship between you and the Blog/Web Site publisher. The Blog/Web Site should not be used as a substitute for competent pharma regulatory advice and you should discuss from an authenticated regulatory professional in your state.  We have made every reasonable effort to present accurate information on our website; however, we are not responsible for any of the results you experience while visiting our website and request to use official websites.

bottom of page