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Thursday, July 28, 2011 4:41 AM | Steve White Volg link

I just found something of interest written in December 2010.  It discusses Teva and the eventuality of Copaxone being generic.  Of course generic drugs are much cheaper and this would cause Teva to take a big hit in the wallet.  They cite safety and efficacy as the cause for concern, but I even question the current efficacy of the damn things.



Steve



Teva submits CP for Copaxone purported generic version



PBR Staff Writer Published 13 December 2010

Teva Pharmaceutical Industries has filed a Citizen Petition (CP) with the US Food and Drug Administration (FDA) requesting that the FDA refuse to approve any abbreviated new drug application (ANDA) for a purported generic version of Copaxone (glatiramer acetate injection).


Teva's requests in this CP are based on the inability to establish acceptable 'sameness' of the active ingredients in glatiramer acetate, the complexity of the mechanism of action of a glatiramoid and the inapplicability of leveraging conventional pharmacokinetic and pharmacodynamic testing methods to demonstrate bioequivalence.


Teva urges that any purported follow-on version of Copaxone undergo pre-clinical testing as well as full-scale clinical trials with measured clinical endpoints in multiple sclerosis (MS) patients to prove safety and efficacy.


Teva also requests that the FDA convene a multidisciplinary Advisory Committee to consider the approval of follow-on glatiramer acetate products in the interest of public health.