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jbog

01/09/16 5:27 PM

#198923 RE: DewDiligence #198918

I haven't followed it recently but the partneship between Biocon of India and Mylan should have many Biosimilars in phase 3 at this time.

Adalimumab (Humira), Pegfilgrastim (Neulasta), Trastuzumab (Herceptin) and Bevacizumab (Avastin) were all in progress at one time. I haven't heard any change. Their were numerous insulin's involved in their deal also.

http://www.biosimilarnews.com/two-biocon-mylan-biosimilar-drugs-enter-global-clinical-trials

DewDiligence

02/22/17 11:33 AM

#209317 RE: DewDiligence #198918

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.