Thanks, ghmm. I just listened to the GENZ webcast segments in question.
>…but Henri Termeer and Alison Lawton seemed to indicate that the hurdle could be higher for approval of biosimilars with the FDA being much more conservative.<
Higher than what, exactly?
The FDA is clearly not treating the new Myozyme as a distinct drug from the old Myozyme; if the FDA were doing that, they would not have allowed the BLA for the new Myozyme to incorporate reams of clinical data from the BLA for the old Myozyme.
Rather, the FDA is effectively treating the new Myozyme as an FoB of the old Myozyme and allowing GENZ to obtain approval of the new Myozyme by merely supplementing the dossier of the old Myozyme with data from a single small study. This is exactly how I expect the FDA to handle most FoB’s, and hence I don’t see how the Myozyme case creates a higher new threshold by FoB’s.
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