Biotech Values

[DewDiligence]

(MNTA)—CHRS’ Humira-FoB study you posted has switching from (branded) Humira to CHS-1420, but it does not have switching from CHS-1420 to Humira. Hence, this study does not satisfy the requirements in the FDA’s draft guidance for interchangeable FoBs. (Compare to #msg-127945401.)

Moreover, no matter what kind of switching study a company conducts, a product won’t be eligible for FDA interchangeable status unless the sponsor has the analytical tools to prove a high degree of sameness to the reference brand. I.e., companies who can’t hope to achieve interchangeable status can save themselves the trouble of conducting a switching study.