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Guidance

Guidance on the licensing of biosimilar products

Guidelines to provide developers of biosimilar products with a clear outline of the requirements in Great Britain.

Updates to this page

From:
Medicines and Healthcare products Regulatory Agency
Published:
6 May 2021
Last updated:
27 February 2025
Show all updates

  1. Added links to guidance on licensing advanced therapy medicinal products and plasma master files and vaccine antigen master files.

  2. Updated guidance document, adding overview and section numbers. Advanced therapy medicinal products (ATMPs) and veterinary master files (VMFs) removed, subject of separate guideline. Windsor framework references and changes added

  3. Updated 'Interchangeability' section with "Likewise, a biosimilar product is considered to be interchangeable with another biosimilar to the same RP. "

  4. First published.

Documents

Guidance on the licensing of biosimilar products

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Details

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.

Applicants should also take into account principles contained within the Committee for Medicinal Products for Human Use (CHMP) guidelines.

This MHRA guidance contains further clarifications and some revisions to these CHMP guidance documents, which take into account the scientific and regulatory experience gained since the first biosimilar product was licensed in 2006, including biosimilar monoclonal antibodies and fusion proteins licensed from 2013.

Further information

Broader guidance to stakeholders and links to educational resources are available in the NHS England publication What is a biosimilar medicine?

This page is for licensing biosimilars only. For ATMPs, see Advanced therapy medicinal products: regulation and licensing in UK. For PMFs and VAMFs, see Licensing plasma master files and vaccine antigen master files.

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