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Re: biopearl post# 2948

Tuesday, 03/06/2007 12:10:45 PM

Tuesday, March 06, 2007 12:10:45 PM

Post# of 19309
>I am unsure as to what biogenerics refers to as well as follow on biologics.<

Biogenenics, follow-on biologics, and biosimilars are different terms for the same thing. They are knockoffs of an approved protein drug that are close enough in structure to the approved drug for regulators to short-circuit the approval process. In other words, approval of a biosimilar drug can be based, at least in part, on the clinical data for the original branded drug.

>Does this mean the agents like Enbrel or Tysabri will lose patent protection and then be made by goats?<

This is a distinct possibility in due course. However, the regulatory pathway to make this happen has yet to be fully defined. Regards, Dew

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