Significant changes are found in the updated Q&A 10 "Is it acceptable to use data from clinical trials conducted in non-Japanese subjects that confirm the equivalence of pharmacokinetics and efficacy (including pharmacodynamics) with the original biopharmaceutical in the marketing application?".

PMDA explains that biosimilar studies are designed to confirm pharmacokinetics (PK) bioequivalence and efficacy, including pharmacodynamics (PD). Therefore, data from overseas studies with non-Japanese participants can be used if the ethnic factors of the participants do not influence the study results. If this should be the case, the methods outlined in the Basic Principles on Global Clinical Trials cannot be directly applied to the Japanese population.

The new Q&A 11 explains how this should be further assessed: the primary objective is to consider the observed quality characteristics between the originator biopharmaceutical and the biosimilar to assess their impact on ethnic factors. You will find the document and more information on the new Biosimilar section on the PMDA website.

Source:

PMDA: (Q&A) Guideline for Ensuring the Quality, Safety, and Efficacy of Biosimilars