Momenta Pharmaceuticals Inc. Message Board

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Biotech / Medical : Momenta Pharmaceuticals Inc.

MNTA 52.48

0.0%

Oct 2 5:00 PM EST

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To: mopgcw who wrote (2812)	10/1/2011 12:43:20 PM
From: tuck	Read Replies (3) of 3027

FDA biosimilar pathway. FDA sources says publication of guidelines is imminent, as in days away or a few weeks. So here is the NEJM article that is supposed to be the blueprint: nejm.org "The FDA will carefully consider what data will be necessary for this purpose and translate that assessment into effective regulatory standards." This sentence makes me wonder if a) FDA hasn't developed interchangeability guidelines for approval yet, or b) FDA will develop interchangeability guidelines for approval on a case by case basis. Obviously, a is bad for Momenta and b is good. Looking forward to clarity on this issue. Cheers, Tuck

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