# Guidance on the licensing of biosimilar products

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/c437ae7d-5935-47ae-8670-e42aa4c7ab47
Type: Guidance
Published: May 5, 2021
Updated: February 27, 2025

> The Medicines and Healthcare products Regulatory Agency (MHRA) has issued comprehensive guidance for developers seeking to license biosimilar medicinal products within the United Kingdom, specifically covering Northern Ireland and Great Britain. As this is a general regulatory framework document rather than an enforcement notice, it does not name a specific company or list inspection dates and violations. Instead, the framework establishes the mandatory standards for the development and approval of similar biological products. The regulatory framework requires applicants to adhere to both MHRA-specific updates and the established principles of the Committee for Medicinal Products for Human Use (CHMP). This guidance incorporates scientific and regulatory insights gained since the first biosimilar approval in 2006, with specific revisions addressing complex products like monoclonal antibodies and fusion proteins. To comply, developers must follow these clarified licensing pathways to ensure their products meet safety and efficacy standards. The MHRA specifies that these requirements are strictly for biosimilars; applicants dealing with advanced therapy medicinal products (ATMPs), plasma master files, or vaccine antigen master files must follow separate, specialized regulatory tracks. This guidance ensures that biosimilar development in the UK remains aligned with international scientific advancements while providing clear procedural steps for manufacturers.

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## Content

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 .

## Attachments

- [Guidance on the licensing of biosimilar products](/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products)