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DewDiligence

06/08/08 1:56 PM

#11557 RE: wjlknew #11553

>I would have thought the definition of a biosimilar would refer to the finished product, not to the process to arrive at the finished product.<

What defines a drug as a FoB or biosimilar is not the process to arrive at the finished product but rather the process to obtain regulatory approval. As stated in my prior post, if a drug obtains regulatory approval without relying, in whole or in part, on the clinical data of another drug, then it is not a FoB or biosimilar––it is simply a branded drug.

I suggest that you reread #msg-28895121.

>Now, there is a self-serving statement if I ever heard one.<

You’re a funny guy, Mr. Wjknew.