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Teva Tries to Combat Generic Drug Competition

7/15/2014

Teva Pharmaceuticals has filed a citizen’s petition with the Food and Drug Administration (FDA) in a new effort to stop generic competition for its Copaxone drug. Copaxone is a medical injection that is used to reduce the frequency of relapse in patients with MS. Last year, the courts invalidated key Teva patents for the drug, opening the door for generic competition this year.

The citizen’s petition argues that “it would be contrary to the public’s health and welfare to approve a purported generic glatiramer acetate product that, based on current analytical technologies at best, can be shown to be similar, but clearly not the same as Copaxone.” Glatiramer acetate is the active ingredient in Copaxone. Teva’s position is that any potential generic version of Copaxone should use the same gene expression markers and biological pathways to demonstrate it has the same safety and efficacy as its drug. The company also argues any generic versions of the drug should be evaluated through pre-clinical testing and full-scale, placebo-controlled clinical trials with measured clinical endpoints, such as relapse rate in patients with relapsing forms of multiple sclerosis to establish safety, efficacy, and immunogenicity.

The FDA said the petition “will allow others the opportunity to comment and participate in the decision-making process, will allow Teva the opportunity to comment publicly on the views and opinions of others, and will facilitate creation of an administrative record on which the agency may base future decisions” regarding applications seeking approval for generic Copaxone products.



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