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biomaven0

07/13/16 12:17 PM

#202603 RE: DewDiligence #202595

I think it's just the FDA being cautious as they roll out the biosimilar program - give experts the chance to raise questions the FDA might not have publicly discussed.

I assume that after a while they will drop the panels for all or most applications.

Peter
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xavierprivas

07/13/16 12:18 PM

#202604 RE: DewDiligence #202595

I agree with it. MNTA has several biosimilars and the path to approval is
a lot easier now.
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DewDiligence

07/13/16 3:16 PM

#202609 RE: DewDiligence #202595

FDA panel votes 20-0 for NVS’ Enbrel FoB. (No link yet.)