FDA approves first generic Copaxone for MS

FDA approved Sandoz’s generic version of Copaxone (glatiramer acetate injection) known as Glatopa, making it the first generic version of the drug available for patients with relapsing forms of multiple sclerosis.

Teva Pharmaceuticals, manufacturer of Copaxone, had tried to persuade the FDA that its MS drug was too complex to copy exactly. Teva had submitted eight petitions with the FDA, with the most recent one dated March 31, 2015. Janet Woodcock, MD, director of the Centers for Drug Evalation and Research, responded to Teva’s petition with a denial letter.

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“For this approval, FDA scientists established a thorough scientific approach for demonstrating active ingredient sameness that takes into consideration the complexity of glatiramer acetate,” according to the FDA statement on April 16.

Glatiramer acetate (Glatopa) consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine. Its mechanism of action is not fully understood, however, it is hypothesized that the drug can modify the patient’s immune functions, according to the package insert.

The recommended dose of Glatopa is 20 mg/mL administered subcutaneously once daily. The drug can be injected into the abdomen, arms, hips, or thighs, using the single-use prefilled syringe.

“Having a generic option for one of the MS disease-modifying therapies is an important milestone, and it has the potential to increase access to MS therapies,” commented Dr. Bruce Bebo, executive vice president of research at the National MS Society. “Early and ongoing treatment is currently the best way we know to reduce future disease activity for people with relapsing forms of MS.”

Potential side effects of Copaxone, which were reported in clinical trials, included injection site reactions (pain, redness, swelling, and itching), rash, shortness of breath, and chest pain.

Glatopa was developed by a team from Sandoz and Momenta Pharmaceuticals. The companies have not yet announced the drug’s availability or price.