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Re: DewDiligence post# 114646

Sunday, 06/12/2011 8:08:28 PM

Sunday, June 12, 2011 8:08:28 PM

Post# of 257251
Enbrel

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?

ps: Enbrel sales were approx $ 1billion in 2010

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