Mylan’s Generic of Copaxone Receives FDA Approval

Two formulations of MS drug earn Teva more than $4 billion

The FDA has approved Mylan's glatiramer acetate injection, the generic version of Copaxone (Teva) for the treatment of patients with relapsing forms of multiple sclerosis (MS). Mylan will begin shipping imminently.

Mylan's abbreviated new drug applications (ANDAs) were approved for two versions of glatiramer acetate injection—40 mg/mL for three-times-a-week injection, and 20 mg/mL for once-daily injection. Both are AP-rated, substitutable generic versions of the Copaxone reference drugs. Mylan CEO Heather Bresch  said the approvals “reinforce our proven capabilities in bringing complex and difficult-to-manufacture products to market.”

As part of its ANDAs, Mylan submitted rigorous side-by-side analyses, including characterization data, which demonstrated that Mylan's glatiramer acetate injection 20 mg/mL and 40 mg/mL have the same active ingredient, dosage form, route of administration, and strength as their branded counterparts.

According to the FDA approval letter, Mylan was one of the first applicants to submit a substantially complete ANDA for glatiramer acetate injection, 40 mg/mL. Mylan and other first filers may be eligible for 180 days of generic drug exclusivity, but the FDA has not yet made a formal determination on exclusivity.

Mylan is introducing Mylan MS Advocate, a comprehensive patient support service program to help patients get started on and stay on track with their physician's treatment plan for either dose strength of Mylan's glatiramer acetate injection. All patients prescribed and taking the drugs are eligible to enroll in the program, which includes an interactive mobile app, in-home injection training, a 24/7 patient support center, copay assistance for eligible patients, and ongoing support from an MS-experienced nurse.

Copaxone is the most prescribed MS treatment for relapsing forms of MS in the United States, with brand sales for the 20 mg/mL dose of approximately $700 million and for the 40 mg/mL dose of approximately $3.64 billion for the 12 months ending July 31, 2017, according to QuintilesIMS. Approximately 400,000 individuals in the U.S. have MS and relapsing MS accounts for 85% of initial MS diagnoses.

Source: Mylan; October 3, 2017.