Peptimmune Files Citizen Petition Regarding Generic Copaxone and Demonstrates Significant Enabling Technology for Biological Characterization of Copaxone
SOMERVILLE, Mass., Oct. 4 /PRNewswire/ -- Peptimmune, Inc. announced today that it has filed a technically focused Citizen Petition requesting that the FDA not approve any application for a generic version of Copaxone® [glatiramer acetate injection] (Teva Pharmaceuticals).
"We feel that it is important for the FDA to have access to Peptimmune's data resulting from our characterization of Copaxone using proprietary methods when considering ANDA applications for generic forms of glatiramer acetate. We believe that manufacturers of any purported generic version of Copaxone need to demonstrate biological equivalence using state of the art methods. Most importantly, this extensive biological characterization that we have developed can serve to further guarantee the safety in multiple sclerosis patients of any purported generic version of Copaxone," stated Thomas P. Mathers, President and Chief Executive Officer of Peptimmune.
The Citizen Petition provides data that highlights several key points for the FDA's consideration:
- Comparative pharmacokinetic (PK) studies with a state of the art method should be required to demonstrate bioequivalence of a purported generic Copaxone
- The demonstrated bioavailability of Copaxone is linearly correlated to its direct effect on the innate immune system
- Pharmacodynamic (PD) studies with state of the art methods are just as important as PK studies due to Copaxone's potent effect on the innate immune system
- Copaxone is a pro-drug which makes the demonstration of bioequivalence very difficult for a purported generic copy
Eric H. Zanelli, PhD, Vice President of Research and Development remarked that, "The safety and efficacy of any proposed generic copy of such a complex drug cannot be guaranteed by physicochemical characterization only. Demonstration of bioequivalen