Mylan launches generic Copaxone in 2 dosage strengths

HERTFORDSHIRE, England, and PITTSBURGH — Just a day after it received approval from the Food and Drug Administration for its generic of Copaxone (glatiramer acetate injection) — both as a 40-mg/mL three-times-a-week treatment and as a 20-mg/ml once-daily injection, the company has launched the drug.

Mylan’s generic was approved with an indication to treat patients with relapsing forms of multiple sclerosis.

“Mylan has invested tens of millions of dollars over many years to bring this important medicine to market,” Mylan CEO Heather Bresch said Wednesday following the drug’s approval. “Providing patients, healthcare providers and caregivers with treatment options is very important when it comes to selecting the right therapy for relapsing forms of multiple sclerosis.”

Copaxone is the most-prescribed treatment for MS, with the 20-mg/ml dosage strength bringing in $700 million and the 40-mg/ml dosage strength bringing in $3.64 billion in the 12 months ended July 31, according to QuintilesIMS data.

The introduction of Mylan’s generic puts it in competition both with branded Copaxone, made by Teva, as well as Sandoz’s previously approved generic Glatopa, which is only available in the 20-mg/ml dosage strength.

As part of the launch, Mylan is introducing its MS Advocate patient support service program to help patients with an interactive mobile app, in-home injection training, 24/7 support, co-pay assistance and ongoing support from a MS-experienced nurse.

“Our commitment to the MS patient community extends beyond bringing generic versions of these products to market,” Bresch said. “Mylan also is offering comprehensive patient support services to help patients access therapy as quickly as possible and adhere to a treatment regimen that fits their needs.”