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Re: DewDiligence post# 198918

Wednesday, 02/22/2017 11:33:38 AM

Wednesday, February 22, 2017 11:33:38 AM

Post# of 257259
Biocentury write-up on interchangeable FoBs (which mentions MNTA in passing) echoes the comments in #msg-119721999 about why FDA interchangeable status doesn’t matter much for infused (as opposed to self-administered) FoBs:

https://www.biocentury.com/biocentury/regulation/2017-02-13/why-few-biosimilar-companies-may-use-fda%E2%80%99s-proposed-

The full article is behind a paywall, but the free portion is enough to get the gist of it.

p.s. MNTA two disclosed FoB programs are for Humira (M923) and Orencia (M834), both of which can be self-administered.

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