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DewDiligence

08/30/11 9:47 PM

#125930 RE: mcbio #125928

…in the case of multiple entrants, isn't it expected that a company would end up launching an authorized generic? Wouldn't those principles apply to the PFE/FoB Enbrel situation as well?

The manufacturer of a branded drug doesn’t need a partner to make and sell an authorized generic; all they have to do is change the packaging. In the case of Enbrel, if MNTA (or, less likely, some other company) obtained FDA approval for a substitutable Enbrel FoB, AMGN/PFE could launch an AG without any assistance from a third party.