Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) today announced that the Company has filed a citizen petition (CP) regarding the approvability of purported generic versions of COPAXONE. Teva submitted this CP according to the FDA’s procedural guidance and in accordance with the Agency’s desire to facilitate public review and comment regarding new scientific data on gene expression. Indeed, Teva previously submitted much of this information to its COPAXONE®New Drug Application (NDA) and FDA responded by asking Teva to resubmit the information as a CP. According to FDA, “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.”
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Teva’s CP 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 withrelapsing forms of mul tiple sclerosis to establ efficacy aish safety, nd immunogenicity.
Teva looks forward ontinued dialogue with the FDA as it reviews and considers the new scientific data and information set forth in the citizen petition.