Biotech Values

[DewDiligence]

Re: Enbrel FoB?

Do you think it is realistic to see MNTA's Enbrel ANDA [assuming there is one] approval and launch before Jan 2014?

No—that’s totally unrealistic, IMO. Also, such an application would not be an ANDA but rather a 351(k) submission.

Some dates of 2016-2017 were bandied around in [GS] 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?

I didn’t catch that reference, so I would have to listen to the webcast again to answer your question. (If anyone reading this knows, please post.)

Enbrel sales were approx $1billion in 2010.

You’re off by a factor of seven (#msg-59851976)! In the US alone, Enbrel sells at an annualized rate of $3.5B.