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MHRA Guidance: Licensing of Biosimilar Products

Recently (08-November-2022) the Medicines and Healthcare products Regulatory Agency (MHRA) released updated Guidance on the licensing of biosimilar products, where they updated the 'Interchangeability' section with "Likewise, a biosimilar product is considered to be interchangeable with another biosimilar to the same Reference Medicinal Product (RP).


A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (the RP).

The guiding principle of a biosimilar development programme is to establish similarity between the biosimilar and the RP based on a comprehensive comparability exercise, ensuring that the previously proven safety and efficacy of the RP also apply to the biosimilar.


This guideline is intended to provide developers of similar biological medicinal products (also known as biosimilar products) with a clear picture of the requirements for biosimilar products in Northern Ireland, Great Britain, and the United Kingdom.


Once authorised, a biosimilar product is considered to be interchangeable with their RP, which means a prescriber can choose the biosimilar medicine over the RP (or vice versa) and expect to achieve the same therapeutic effect. Likewise, a biosimilar product is considered to be interchangeable with another biosimilar to the same RP.


As a result of interchangeability, switching patients from one product to another (RP or biosimilar) has become clinical practice.


Click this LINK to know more about the General principles, Content of a biosimilar application, Traceability, Interchangeability, and more from this guidance.


Also, click this LINK to know about how to change your protocol, update your authorisation, report safety issues, submit safety updates, and complete your end-of-trial study report from the recent guideline on "Guidance: Clinical trials for medicines"


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