Guidance

Guidance on the licensing of biosimilar products

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

From:
Medicines and Healthcare products Regulatory Agency
Published
6 May 2021
Last updated
720 NovemberDecember 20222024 — See all updates

Documents

Guidance on the licensing of biosimilar products

HTML

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 givenavailable in the NHS England publication ‘WhatWhat is a biosimilar medicine?’medicine?

Updates to this page

Published 6 May 2021
Last updated 720 NovemberDecember 2022 2024 + show all updates

  1. 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

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

  4. First published.

Sign up for emails or print this page