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microcapfun

12/26/10 12:40 AM

#111489 RE: poorgradstudent #111488

>>The TNF blocking antibodies<<

Thanks for the lesson. So Cimzia and Simponi have essentially the same labels as Humira?

I believe you - but I don't get it. If Cimzia and Simponi came on the scene many years later it would seem that they would at least have had to pass a non-inferiority trial against Humira, similar to Dew's comments regarding Incyte's 050.

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DewDiligence

12/26/10 1:03 PM

#111503 RE: poorgradstudent #111488

With the exception of Humira, the drugs you cited have been commercial dogs. Although a drug can get FDA approval in RA by showing superiority to placebo, commercial uptake is greatly enhanced if the sponsor can show at least non-inferiority relative to a big-selling comparator.