Sandoz Announces Launch of Glatopa™
The launch of Glatopa™ (glatiramer acetate injection) in the United States was announced yesterday by Sandoz, a Novartis company. Glatopa is manufactured by Sandoz and is the 13th medication to be approved by the FDA as a long-term, disease-modifying therapy for multiple sclerosis (MS). This generic version of Copaxone® (glatiramer acetate injection) was approved on April 16, 2015, for the treatment of individuals with relapsing forms of MS, including those who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with MS.
According to the press release from Sandoz, the pharmaceutical company has begun shipping Glatopa to pharmacies in the United States. They have also set up a 24-hour phone line at 855-GLATOPA, or (855) 452-8672, for members of the MS community to speak with a nurse with any questions about Glatopa. Individuals may also call this same phone line to speak with someone about financial assistance between the hours of 8:00 am and 8:00 pm ET. Sandoz has a website set up at glatopa.com, although at the time of this news article, it was not yet complete. It does, however, provide a link to prescribing information.
Glatopa is a generic version of Copaxone, and is the first generic version of a disease-modifying therapy for MS to be approved by the FDA. Copaxone has been marketed by Teva Pharmaceuticals since its approval in the mid-1990s. Both Glatopa and Copaxone are given via subcutaneous (under the skin) self-injections, although readers should note that Glatopa is only available in the once-daily 20-milligram dose, whereas Copaxone also offers a newly approved, three-day weekly administration of 40 milligrams each.
Since a generic drug is not required to undergo the same clinical trial process as the original drug, the generic drug is supported by study findings (to indicate effectiveness and safety) from the original drug. According to Sandoz and the FDA, Glatopa is therapeutically equivalent to and substitutable for Copaxone. Individuals who may be interested in this new treatment option should discuss this medication with their treating physician.
For more details on Glatopa, including safety and effectiveness information, please refer to MSAA’s online news item posted April 17, 2015, “Glatopa™ (glatiramer acetate injection) Approved for the Long-Term Treatment of Relapsing Forms of MS.?
For more information on treatments for MS and other MS-related questions, individuals may contact MSAA’s Client Services Specialists via email, phone, or our online chat feature. Please see the information below for contact details.
- Questions may be sent via email to MSquestions@mymsaa.org.
- MSAA’s Client Services Specialists may also be reached by calling (800) 532-7667, extension 154. (Please note that MSAA’s Specialists are available during normal business hours, 8:30 am to 5:00 pm ET, Monday through Friday.)
- MSAA offers an interactive one-on-one chat feature that allows individuals to ask questions about MS while browsing MSAA’s website.
Written by Susan Wells Courtney, MSAA Senior Writer and Creative Director
Reviewed by Jack Burks, MD, MSAA Chief Medical Officer