Module 9 2021

22/03/2021

PD CLINICAL ENDPOINTS

Coherus PegFilgrastim – Entire program in healthy volunteers – Single dose PK/PD study

– Immunogenicity – two doses in ~300 patients – FDA did not request additional clinical study to be performed in oncology patients

GABI OnLine 11/11/2016: FDA accepts application for pegfilgrastim biosimilar from Coherus; CliniTrials.gov

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IMMUNOGENICITY CONSIDERATIONS

48

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