wheeler said, they are working on follow on biologics much before lovenox ANDA was filed (hope i heard this right? or did he say approved?)
Say MNTA is working on Enbrel from 2008 Say FDA defines pathway by Jan 2012 Say MNTA files ANDA in Feb 2012 (not sure Enbrel would require some clinical trial - ofcouse that depends on how much sameness MNTA can demonstrate) Say FDA takes 18 months to review Enbrel ANDA Do you think it is realistic to see MNTA's Enbrel ANDA approval and launch before Jan 2014 ?
Some dates of 2016,2017 were bandied around in the conference call ...Can somebody put that in context ? Was CW saying the 1st bio-similar in the US could get approved/launched as early/as late as 2016?
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