Module 9 2021

22/03/2021

JAPAN

Need ethno-bridging data – PK/PD study in Japanese patients (suitability of HVs should be discussed with MPA) – OR Include adequate Japanese patients in global study – OR Include Japanese subjects in PK equivalence trial – If clinical data from trials that do not include any people of Japanese ethnicity are used to show the similarity between a biosimilar candidate and the reference product, the extrapolation of these data to the Japanese population should be justified according to the International Conference on Harmonisation guideline E5 (R1). 6

21

CHINA Major Changes ● Much faster approval timeline ● Faster & Cheaper Clinical development in China ● New drug definition to encourage company to put China into the first round of global registration by favoring re- imbursement ● Aim to align with ICH requirements; in parallel will also take China specific requirements into consideration. – CMC: China pharmacopoeia & guidance; “establish condition” – Chinese safety & efficacy profile must be well address by taking ICH E5&17 into consideration

22

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