Glatopa™ (glatiramer acetate injection) Approved for the Long-Term Treatment of Relapsing Forms of MS
On April 16, 2015, the United States Food and Drug Administration (FDA) approved Glatopa™ (glatiramer acetate injection) for the treatment of individuals with relapsing forms of multiple sclerosis (MS), including those who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with MS.
Glatopa is manufactured by Sandoz, a Novartis company, and is the 13th medication to be approved by the FDA as a long-term, disease-modifying therapy for this form of MS.
Glatopa is a generic version of Copaxone® (glatiramer acetate injection), which has been marketed by Teva Pharmaceuticals since its approval in the mid-1990s. This is the first generic version of a disease-modifying therapy for MS to be approved by the FDA. According to Sandoz, Glatopa is therapeutically equivalent to and substitutable for Copaxone. However, 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. Both medications are given via subcutaneous (under the skin) self-injections.
Sandoz states that it has met all of the FDA’s requirements for a generic, which includes showing that Glatopa contains the same active ingredient as Copaxone and is identical in strength, dosage form, and route of administration. Additionally, this medication was developed in collaboration with Momenta Pharmaceuticals Inc. and is manufactured entirely in the United States.
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 the FDA’s press release on the approval of Glatopa, it states the following as potential adverse events: “In the clinical trials for Copaxone, the most common adverse reactions reported by those taking Copaxone were skin problems at the injection site (redness, pain, swelling and itching), flushing (vasodilation), rash, shortness of breath and chest pain.”
In terms of effectiveness, Copaxone has been shown to significantly reduce the annual relapse rate in RRMS and reduce the risk of people with CIS for developing clinically definite MS (CDMS) at two years. For more information on the efficacy of Copaxone and its mechanisms of action, please refer to this year’s MS Research Update, found by going to mymsaa.org, selecting “MSAA’s Publications” under “About MS,” and then going to the most-recent version of the update.
In May 2014, MSAA published an online news item titled, “The Issues Surrounding Generic Versions of MS Drugs.” In this article, the challenges relating to the development and testing of both biosimilar drugs (those made from living cells that cannot be reproduced identically) and to drugs not considered to be biologics but that have complex molecular structures, are presented. This latter category applies to generic versions of Copaxone, which is discussed in the article.
In October 2014, MSAA published an online news item titled, “Highlights from the 2014 Joint ACTRIMS-ECTRIMS Meeting.” In this article, we discuss the study results from a generic version of Copaxone, as follows, “A nine-month randomized, double-blind trial of 794 people with RRMS, called ‘GATE,’ demonstrated that generic glatiramer acetate was equivalent to Copaxone® and superior to placebo in both safety and efficacy. The concept of generic versions of MS disease-modifying therapies is relatively new to the MS community, as the original drugs were protected by law to have a certain period of exclusivity. As these time periods expire, other pharmaceutical companies may look to provide similar drugs.”
Please note, however, that the GATE study mentioned above was looking at a potential generic version of Copaxone developed by Synthon, called Synthon GTR. This is different from Glatopa, which was developed by Sandoz.
At this time, we do not know when Glatopa will be available for physicians to prescribe. Given that the patent laws protect Teva’s exclusive marketing of Copaxone until September of this year, the assumption is that this generic version will not be released until after that time. We also have not been given any information about the product’s pricing.
MSAA Chief Medical Officer Jack Burks, MD is pleased to see the approval of another disease-modifying therapy option for individuals with MS. He explains, “I welcome generic medications for MS. They will potentially permit even more access to DMTs for people with MS. The price of the generics will help determine their acceptance, and the pharmaceutical company’s patient support and assistance programs will also be important considerations.”
Please note that MSAA will post updates for the MS community as more details become available on this newly approved medication.
For more information from the FDA, individuals may refer to any of the writings noted below.
Anyone with comments or questions for the FDA may contact them at: (888) INFO FDA, (888) 463-6332, or (301) 796-3400 from 8:00 am – 4:30 pm eastern time, Monday through Friday. Individuals may also email the FDA at firstname.lastname@example.org.
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