Teva Pharmaceutical Industries Ltd. announced that the company 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.
Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients.