Today, UK’s Medicines & Healthcare products Regulatory Agency (MHRA) published the final guidance on the licensing of biosimilar products, lowering the barrier for biosimilar drug to enter the market.
Today’s final version follows draft guidelines the MHRA released last year, which was built on the European Medicines Agency (EMA) guidelines. The MHRA highlighted the draft’s two significant deviations from the EMA guidelines: the lack of requirement to conduct in vivo animal studies, and changes in the requirement for a comparative efficacy study. In the final guidelines, MHRA states that “these (in vivo studies) are not relevant for showing comparability between a biosimilar candidate and its RP (reference product)”. MHRA relaxed requirement for a comparative efficacy trial, stating that “in most cases, a comparative efficacy trial may not be necessary if sound scientific rationale supports this approach.” Sponsors are now only required to provide justifications for comparable efficacy, on the basis of drug product characteristics, formulation, and results from the confirmatory PK trials.