FDA Approves Two Doses of Generic Copaxone for MS

On October 4, 2017, Mylan announced that two doses of their generic version of Copaxone® (glatiramer acetate) had been approved by the United States Food and Drug Administration (FDA) for relapsing forms of multiple sclerosis (MS). These two separate treatments include 40 mgs taken three-times weekly and 20 mgs taken once daily, both of which are given via subcutaneous (under the skin) self-injections. Available by prescription, patients and their physicians may choose between either dose regimen, and either may be given with Mylan’s WhisperJECT™ autoinjector. According to Mylan’s press release, the medication is already being shipped to customers.

Copaxone was originally approved in 1996. Initial studies showed that it reduced relapses and it was subsequently found to reduce disease activity as shown on magnetic resonance imaging (MRI). In 2014, a 40-mg dose injected three-times weekly was approved by the FDA. In April 2015, Glatopa® (glatiramer acetate injection) was the first generic version of Copaxone to be approved at the 20-mg daily-injection dose.

The approval of Mylan’s generic version of Copaxone is the 16th disease-modifying therapy/brand to be approved for the long-term treatment of MS, and is the first generic version of Copaxone to be approved at the 40-mg dose (in addition to its 20-mg dose). Mylan notes that with this FDA approval, their generic medication “may be substituted for the equivalent dose of Copaxone and may be expected to have a comparable safety and efficacy profile.”

Mylan offers patient support and financial assistance through its Mylan MS Advocate™ program, which may be accessed through their website at www.glatirameracetate.com or via phone at (844) MylanMS or (844) 695-2667. Trained MS Advocate nurses are available around the clock, seven days per week, to answer questions about MS, glatiramer acetate, and injection techniques. Individuals will also have access to a trained Benefits Advocate who can assist with coordinating insurance, enrolling in Mylan’s co-pay program, and finding other sources of financial assistance.

For additional information on MS or to speak with a trained Client Services Specialist, please call MSAA’s Helpline at (800) 532-7667, extension 154. Questions to MSAA’s Client Services department may also be emailed to MSquestions@mymsaa.org.

Written by Susan Courtney, MSAA Senior Writer

Reviewed by Dr. Jack Burks, MSAA’s Chief Medical Consultant