MHRA draft guidance on the licensing of biosimilar products

We have drafted new guidance to help developers of similar biological products (also known as biosimilars) more clearly understand the requirements for biosimilar products in the UK.

This guidance is based on the current EMA biosimilar guidance, with additional details about:

• UK reference products
• the lack of requirement for in vivo studies in animals
• the changes in the requirement for a comparative efficacy trial in most cases

This 6-week consultation aims to get feedback from relevant stakeholders regarding the clarity and wording of the guidance, including any perceived contradictions or omissions. We are hoping to finalise the guidance by the end of the year.

How to respond

1. Download the response form
2. Complete the form and email it to biosimilars@mhra.gov.uk
3. Alternatively, send your comments directly by email to biosimilars@mhra.gov.uk