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Guidance on the Licensing of Biosimilar Products - United Kingdom (MHRA)

Updated: Aug 21, 2021

What is a Biosimilar Medicine?

Biosimilar medicine is a biological medicine that is developed to be highly similar and clinically equivalent (in terms of quality, safety and efficacy) to an existing biological medicine that has already been authorised in the European Union, (known as the reference biological medicine or originator medicine).

Biosimilar medicines should be considered to be therapeutically equivalent to the reference medicine within their authorised indications.

The purpose of this guideline is to provide developers of similar biological medicinal products (also known as biosimilars) with a clear outline of the requirements for biosimilar products in Northern Ireland/Great Britain/UK.

The guidance is effective from 6 May 2021.


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