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Biotech / Medical : Momenta Pharmaceuticals Inc. -- Ignore unavailable to you. Want to Upgrade?

To: mopgcw who wrote (2812)	8/4/2011 7:08:07 PM
From: software salesperson	Respond to of 3027

merchantgould.com analysis of the legal and legislative aspects of the biosimilars law by an intellectual property attorney

To: mopgcw who wrote (2812)	10/1/2011 12:43:20 PM
From: tuck	Read Replies (3) \| Respond to 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