I think that unfortunately the FDA has become a politcal beast that is beholden to the people that they are out to regulate and that in instances like this there's big $$$ out there slowing down the approval path for generic biologics and other generics.
I can't say I blame companies for tryign to protect their investments and tehre is a tradeoff - cheap drugs vs real innovation. But so many of the recent drugs have been small tweaks on existing ideas and its very infrequent there's a true innovative and novel way to combat a disease.