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DewDiligence

07/12/17 2:42 PM

#83 RE: tika1 #82

…what is a success rate of approval of FOBs.

In the US, specifically, there are too few data points to give a meaningful success rate. Moreover, some FoBs, such as AMGN’s Amjevita (Humira FoB)s have been approved by the FDA but not yet launched due to litigation.

In the EU, the approval rate for FoBs has been very high; however, the EU does not have interchangeable FoBs, so FoB products must be marketed as branded drugs to garner any meaningful commercial uptake.

Do you personally think that CHRS is a good investment?

Not particularly. I prefer MNTA, which has more going on than just FoBs (see #msg-132316871).