FDA Approves Mylan’s Generic Copaxone, Introducing First Generic High-Dose Version

The U.S. Food and Drug Administration has approved both lower and higher doses of Mylan’s generic versions of Copaxone (glatiramer acetate) for relapsing multiple sclerosis.

It is the first time the agency has authorized a higher-dose generic.

Generic versions of the lower dose of 20 mg/mL — intended for daily injections — have been around for some time. The FDA approval covers both Mylan’s higher dose of 40 mg/mL of glatiramer acetate and the lower dose. Those using the higher dose will be able to reduce their injections to three times per week.

The approval was based on analyses showing that both doses of the generic were equivalent to the original Copaxone, developed by Teva. This allows the generics to be rated as therapeutically equivalent, or AP.

Mylan will start shipping the drug immediately, it announced in a press release.

“The FDA approvals of Mylan’s Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL as AP-rated, substitutable generics for Copaxone 20 mg/mL and 40 mg/mL, respectively, mark another significant milestone for our company,” Heather Bresch, Mylan’s CEO, said in a press release. The approvals also “reinforce our proven capabilities in bringing complex and difficult-to-manufacture products to market, and further our commitment to providing access to high quality medicines,” she said.

The approval may allow patients to lower the cost of their MS treatments. Since Copaxone is the most prescribed MS drug in the United States, the introduction of additional generics is likely to help many  patients. To help patients make the switch, Mylan has started a patient support program called Mylan MS Advocate.

In addition to co-pay assistance for eligible patients, the program will help patients stay on track with their treatment plan, including working with a nurse specializing in MS.

“Mylan has invested tens of millions of dollars over many years to bring this important medicine to market,” Bresch said. “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.

“Our commitment to the MS patient community extends beyond bringing generic versions of these products to market. 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,” she said.