Teva Pharmaceutical Industries Ltd., has filed a citizen petition (CP) regarding the approvability of generic versions of Copaxone (glatiramer acetate injection), a drug to treat relapsing forms of multiple sclerosis. 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.

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. In a statement, Teva said that FDA said the CP 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 said its CP provides new scientific data on gene expression and evidence to support arguments regarding active ingredient sameness, immunogenicity, and bioequivalence testing with regard to 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 said “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.”

Copaxone is Teva’s best-selling drug with 2013 revenues of $4.33 billion, accounting for 21% of the company’s 2013 revenues. The US Orange Book patents covering Copaxone expired in May 2014. The company has patents expiring in May 2015 in most of the rest of the world. A number of competitors in the United States, including Momenta/Sandoz, Mylan/Natco, and Synthon, have filed abbreviated new drug applications for generic versions of Copaxone. In January 2014, the FDA approved Teva’s supplemental NDA for Copaxone 40 mg/mL, a higher dose of Copaxone with a three times a week dosing regimen According to the company’s 2013 annual filling, the company’s business strategy for Copaxone relies heavily on the successful introduction of a three-times-a-week product and the migration of a substantial percentage of current daily Copaxone patients to this new version.

Source: Teva Pharmaceutical Industries