MHRA Guidance on the Licensing of Biosimilars

In October 2020, the MHRA released new draft guidance on UK biosimilar assessment procedures post-Brexit (the “Guidance”), which is available here. The deadline for the consultation on this Guidance is 15 November 2020.

An interesting point raised in the Guidance is the suggested relaxation in the requirement for comparative clinical efficacy trials for biosimilar medicines. It would appear that there is a move in the MHRA to shift basing findings of biosimilarity sufficient to justify granting an abridged marketing authorisation referencing a biologic reference product away from clinical comparability trials in favour of reliance on robust comparative physicochemical data and pharmacokinetics studies. The suggested guidance would mean that, in most cases, from 1 January 2021, comparative efficacy trials will not be required. Paragraph 3.3 of the Guidance states:

“In most cases, a comparative efficacy trial is not considered necessary. A well-argued justification for the absence of an efficacy trial should be appended to CTD Module 1 of the submitted application. Applicants are encouraged to seek scientific advice to discuss this approach as soon as they have sufficient comparative analytical and functional data to support it.”

In some cases, however, for example where safety uncertainties cannot otherwise be resolved, there may still be a requirement for comparative efficacy/safety trials.

This move is in contrast with the assessment regimes applied by the FDA or EMA, under which a biosimilar product application must include data from analytical studies demonstrating high similarity with the reference product, animal studies and clinical studies to demonstrate safety, purity and potency of the biosimilar. If they were to come into effect, the proposed changes could represent a step forward for the approval of biosimilars in terms of speed to market and the cost of the data packages, at least for the UK market.

The Guidance has the potential to open a gateway to earlier UK biosimilar product launches. However, with clinical comparability studies still likely to be a requirement for global product developments, the effect of the MHRA’s change of approach is unlikely to have a significant impact on effective regulatory barriers to entry for biosimilar companies on a broader, global scale.