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news.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).
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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.