The generic player M/S Mylan announced ( in a press release Here) that the U.S. Food and Drug Administration (FDA) has accepted for filing of Mylan Pharma's abbreviated new drug application (ANDA) for Glatiramer Acetate Injection (20 mg/ml), which is a generic version of innovator M/S Teva Pharma’s Glatiramer acetate injection (Copaxone). Glatiramer acetate injection (Copaxone) is indicated for the treatment of multiple sclerosis.
Also, Mylan entered into a license and supply agreement with Hyderabad based M/S NATCO Pharma which granted Mylan exclusive distribution rights for Glatiramer Acetate pre-filled syringes in the U.S. and all major markets in Europe, Australia, New Zealand, Japan and Canada. The agreement also includes an option to potentially expand into additional territories.
Earlier, in Jul, 2008, the generic player Sandoz (Momenta), a subsidiary of M/S Mylan filed ANDA for this product. Subsequently, in Aug, 2008, innovator sued the generic players in New York Southern District Court. As per complained filed against generic players, Teva opposed any generic version before patent expiry in May 24, 2014. (As detailed in our previous post Here )
Additionally, Teva filed a Citizen Petition on September 8, 2008 with the USFDA, wherein, Teva opined that designing around against this formulation would be extremely difficult and presents a significant challenge. Also, once injected, it is rapidly hydrolyzed locally and no level of the intact drug can be measured in the blood, rendering a bioequivalence study comparing two formulations extremely difficult.
Arguably, the mechanism of the drug product is not fully clear. Also, Innovator Teva requested in the citizen petition that generic players should carry out detailed clainical studies to establish quality, safety and efficacy of the generic product. Alternatively, Teva suggested USFDA that ANDA on Copaxone should be reviewed under 505 (b) (2) category.
In response to the citizen petition, USFDA refused to review the Citizen petition and communicated Teva that as ANDA review process is stayed till 30 months, it would be premature and inappropriate to address points raised by Teva before actual ANDA review process begins. (As detailed in our previous post Here )
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