Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has filed a citizen petition with the US Food and Drug Administration (FDA) regarding the approvability of generic versions of Copaxone
Teva submitted the petition according to the FDA’s procedural guidance and in accordance with the FDA's desire to facilitate public review and comment regarding new scientific data on gene expression. Teva has in fact previously submitted much of this information in its Copaxone New Drug Application (NDA) and the FDA asked Teva to resubmit the information as a petition.
The FDA said, “This 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.”
Teva’s petition provides new scientific data on gene expression and evidence to support arguments regarding active ingredient sameness, immunogenicity and bioequivalence testing with regard to its relapsing-remitting multiple sclerosis medicine Copaxone.
As Teva’s data show, 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 and confirmed by techniques such as gene expression evaluation, at best can be shown to be similar, but clearly not the same as Copaxone. Teva’s position is that any potential generic version of Copaxone should use the same gene expression markers and biological pathways to demonstrate sameness, as well as be evaluated via 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.
Teva says it looks forward to continued dialogue with the FDA as it reviews and considers the new scientific data and information set forth in the citizen petition.
Published by Globes [online], Israel business news - www.globes-online.com - on July 3, 2014
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