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.
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