MHRA draft guidance on the licensing of biosimilar products
Detail of outcome
The MHRA guidance on the licensing of biosimilar products allows a more streamlined approach to development of biosimilar products, building on the existing CHMP biosimilar guidance and more recent experience with biosimilar monoclonal antibodies and fusion proteins since 2013. The guidance encourages a stepwise approach to development of biosimilar products, with emphasis on the comprehensive physicochemical and biological comparability studies, functional (in vitro) analysis and a confirmatory clinical PK (pharmacokinetic) study. Confirmatory clinical efficacy studies are not required in most cases, although suitable justification is necessary. In vivo animal studies are not requested.
The consultation invited comments from stakeholders on the draft guidance on the licensing of biosimilar products. Responses were received from various pharmaceutical companies (3 innovator companies and 8 biosimilar developers/companies), 8 trade associations, 2 patient organisations, 2 regulatory consultants, 2 scientific publishers and 2 individuals. This feedback helped the MHRA to finalise and publish this guidance.
The majority of comments were supportive of the draft guidance allowing a more streamlined approach to licensing of biosimilars. Some of these respondents also encouraged the MHRA to go further and take a lead in global regulation of biosimilars. A few respondents questioned the basis for not requiring confirmatory clinical efficacy and in vivo animal studies; more detailed discussion of the scientific reasoning can be found in recent peer reviewed publications: Streamlined approval of biosimilars: moving on from the confirmatory efficacy trial; Bielsky et al. (2020) and The Path Towards a Tailored Clinical Biosimilar Development; Schiestl et al. (2020). Some comments highlighting apparent divergence from CHMP guidance reflected a misunderstanding of the CHMP guidance. Therefore, some clarifications have been introduced in the final MHRA guidance.
There were a number of comments on specific wording in the guidance, with proposals for changes and/or improved wording for clarification. Many of these have been adopted in the final guidance. Comments were received from two patient organisations requesting that factors which are important for patients are considered (for example, injection pain and allergenic components); these have been included in the guidance to ensure that this are taken into account early in the biosimilar development process.
Some general questions were received requesting clarification on the types of marketing authorisation available for biosimilar products after the end of the transition period and the Northern Ireland Protocol, which had not been finalised at that stage (October/November 2020). Submission routes and timelines for assessment of biosimilar products are described on the MHRA website.
Clarification was also requested on sourcing the reference product. Further information has been added to the guidance to address these questions, to take into account any changes after leaving the EU on 31 December 2020.
All the comments received have been carefully considered during revision of the guidance, and when relevant and in line with the MHRA approach, they have been implemented in the final guidance.
Original consultation
Consultation description
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
- Download the response form
- Complete the form and email it to biosimilars@mhra.gov.uk
- Alternatively, send your comments directly by email to biosimilars@mhra.gov.uk
Documents
Updates to this page
Published 7 October 2020Last updated 10 May 2021 + show all updates
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Newly included final outcome and feedback.
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First published.