A generic equivalent of daily Copaxone® (glatiramer acetate, 20 mg), called “Glatopa”™ (Sandoz, a Novartis company, developed in collaboration with Momenta Pharmaceuticals) that was approved by the U.S. Food and Drug Administration in April, has been launched in the U.S. Glatopa is a disease-modifying therapy for people with relapsing forms of MS, including those who have experienced a first clinical episode and have MRI features consistent with MS.
The generic medication is a 20mg dose injected under the skin every day. This approval means that the manufacturer provided evidence that this generic medication is equivalent to the brand-name drug (Copaxone®).
According to Novartis which owns Sandoz, Glatopa would have a wholesale list price of about $63,000 per year. This is an estimated 15- 18 percent less than the list price of daily Copaxone. Sandoz advises that it will offer support services that include financial assistance to qualified patients, personalized injection training and 24-hour access to nurses for non-clinical questions, services not typically offered for generic medications.
“Having a generic option for one of the MS disease-modifying therapies is an important milestone, and it has the potential to increase access to MS therapies,” commented Dr. Bruce Bebo, Executive Vice President, Research at the National MS Society. “As more generic and biosimilar options become available, we are hopeful that we will start to see some price relief for people living with MS” he added.
“Health care professionals and patients can be assured that FDA-approved generic drugs have met the same rigorous standards of quality as the brand-name drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, in an FDA press release. “Before approving this generic product, given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand name product.” The FDA’s press release provides additional details (available here) related to how the agency determined the generic’s equivalency.
Selecting a therapy should be done by people with MS in collaboration with their MS doctors, taking into account a variety of factors, including the effectiveness of any therapy they are currently using, and weighing potential risks and benefits, costs and lifestyle factors.
About Glatopa: The FDA has approved a generic medication that has been shown to be equivalent to 20mg daily glatiramer acetate. Glatopa is not a generic version of the 40mg dose of Copaxone taken every three days. Glatiramer acetate is a synthetic protein that mimics myelin basic protein, a component of the myelin that insulates nerve fibers in the brain and spinal cord. This therapy seems to block myelin-damaging T-cells through a mechanism that is not completely understood. The approved generic form of glatiramer acetate is given by subcutaneous (under the skin) injections every day.
Potential benefits: In clinical trials of glatiramer acetate, it was shown to significantly reduce annual relapse rates and new brain lesions as shown on magnetic resonance imaging (MRI), when compared to those who were given a placebo. This therapy has had a long track record of effectiveness and safety.
As part of the generic medication approval process, the FDA requires that generics have the same active ingredients, strength, dosage and mode of administration as the brand-name medication, and that they are manufactured according to federal quality control regulations. Clinical trials are generally not required to prove equivalence to a brand-name medication.
Potential risks and side effects: Side effects of glatiramer acetate that generally resolve on their own and do not require medical attention unless they continue for several weeks or are bothersome include injection-site reactions (e.g., swelling, the development of a hardened lump, redness, tenderness, increased warmth of the skin, itching at the site of the injection); runny nose; tremor; unusual tiredness or weakness; and weight gain. There is also the potential for local damage to the skin (necrosis) and underlying tissue (lipoatrophy).
Some people using glatiramer acetate experience, at one time or another, a very temporary reaction immediately after injecting glatiramer acetate. This reaction, which often occurs only once, includes flushing or chest tightness with heart palpitations, anxiety, and difficulty breathing. During the clinical trials, these reactions occurred very rarely, usually within minutes of an injection. They lasted approximately 15 minutes and resolved without further problem.
Unusual side effects of glatiramer acetate that should be discussed as soon as possible with your doctor include hives (an itchy, blotchy swelling of the skin) or severe pain at the injection site.
The National MS Society will provide more information about generic glatiramer acetate as it becomes available.
Download prescribing information (.pdf)
Read a press release from the FDA
Read more about disease-modifying therapies and other treatments for MS and MS symptoms.

Frequently Asked Questions: Approval of Generic Glatiramer Acetate

When will generic glatiramer acetate be available for prescription?

• There is no information yet about when this medication, called Glatopa, will be available for prescription in the United States.

What will the generic glatiramer acetate cost?

• Though we don’t have specific costs of Glatopa at this time, according to Novartis which owns Sandoz, the product would have a wholesale list price of about $63,000 per year.

What does it mean for a therapy to go generic – will Copaxone still be available for prescription?

• As patent protections expire for Copaxone, other manufacturers are free to replicate it and seek drug regulatory agency approval to market it.
• For many medications available as generics, the brand-name medications remain on the market. From the information currently available, it is expected that Copaxone will continue to be available by prescription in both the 20mg once daily dose, and the 40mg dose taken every three days.

What about insurance coverage for the generic or for Copaxone – will I be forced to switch from my current medication?

• Coverage of prescriptions differs among various insurers. At this point we don’t know how insurers will handle coverage of Copaxone versus generic glatiramer acetate.

Does this generic medication 20mg dose have the same therapeutic benefit as 20 mg Copaxone?

• The FDA has a thorough review process and guidelines in place to evaluate the equivalence of proposed generic drugs to brand name drug products.
• If the FDA reviews and approves a generic medication, it means the medication’s maker has provided sufficient evidence that the generic will have the same therapeutic benefits as the brand-name product.
• The U.S. FDA is empowered by Congress to evaluate generic drug candidates through Abbreviated New Drug Applications.
• The National MS Society has confidence in the FDA’s processes.

Will patient support services be available to people who are prescribed Glatopa?

• According to Sandoz, it will offer support services that include financial assistance to qualified patients, personalized injection training, and 24-hour access to nurses for non-clinical questions.

Frequently Asked Questions: Generic Therapies for the Treatment of MS

The MS therapy landscape is continuously evolving. Two decades ago there were no disease-modifying therapies available, and now there are more than a dozen. We have also reached the point where “generic” versions of MS therapies are entering the marketplace. The following provides information about generic drugs and what they may mean for the MS community.
What is a generic medication?

• A generic medication is a product that is equivalent to a brand-name drug whose patent protections have expired.
• As part of the generic medication approval process, the FDA requires that generics have the same active ingredients, strength, dosage and mode of administration as the brand-name medication, and that they are manufactured according to federal quality control regulations.
• Generic makers are required to show that the generic drug delivers the same amount of active ingredients to the person’s bloodstream in the same amount of time as the brand-name product (referred to as “bioequivalency”).

What is the Society’s view of generic therapies for MS?

• The National MS Society advocates for increased treatment options for people with all forms of MS. Early and ongoing treatment is currently the best known way to reduce future disease activity.
• Having approved generics has the potential to increase individuals’ access to MS therapies and provides the MS community with more options.

Does the National MS Society recommend the use of this new generic MS therapy?

• The National MS Society does not make individual treatment recommendations, but as we do for all other approved therapies, we make information available to constituents so that they can make informed decisions about their treatment choices.

Do generic medications have the same therapeutic benefit as name-brand medications?

• The FDA has a thorough review process and guidelines in place to evaluate the equivalence of proposed generic drugs to brand name drug products.
• If the FDA reviews and approves a generic medication, it means the medication’s maker has provided sufficient evidence that the generic will have the same therapeutic benefits as the brand-name product.
• The U.S. FDA is empowered by Congress to evaluate generic drug candidates through Abbreviated New Drug Applications.
• The National MS Society has confidence in the FDA’s processes.

Will there be equivalent medications for all MS therapies?

• It’s possible that eventually there will be. But before any medication may be copied, the patents protecting the brand-name medication must expire. Then a maker of equivalent medications would need to apply to the FDA with a request for approval of its medication.
• The term “generic” technically applies to products that are considered drugs made through a chemical manufacturing process. Some of the MS therapies are classified as chemical drugs, and so when their patents expire, they would likely be eligible to be manufactured as generics. These FDA-approved therapies are classified as chemical drugs: Aubagio, Copaxone, Gilenya and Tecfidera.
• The other MS therapies -- Avonex, Betaseron, Extavia, Lemtrada, Plegridy, Rebif, and Tysabri -- are technically classified as “biologics.” Biologics are generally more complex and they are made from human or animal materials rather than chemical processes. The technical term for equivalent medications for biologics is “biosimilar” or “follow-on biologic.”
• The FDA has long-established requirements for the approval of generic medications, and has recently released guidelines related to the approval of biosimilars.

What is the current progress toward developing equivalent medications for MS therapies?

• The FDA just approved a generic form of glatiramer acetate, and the agency has received Abbreviated New Drug Applications for other generic forms of this medication.
• With the exception of Novantrone and Copaxone, no other disease-modifying MS medications are available in a generic form.

Where can I get more information about generic drugs and biosimilars?
The FDA’s Website has information about generic drugs and biosimilars and processes for their approval.
Copaxone is a registered trademark of Teva Pharmaceutical Industries LTD.
Glatopa is a trademark of Novartis AG

Collaborating researchers in the U.S. and Italy have uncovered a gene variant that appears to influence whether a person responds well to interferon beta, a commonly used therapy for relapsing forms of MS. More broadly, the gene may regulate immune activity in unexpected ways, and its discovery may lead to new approaches to stopping inflammation and immune attacks in MS. Drs. Federica Esposito and Filippo Martinelli Boneschi (San Raffaele Scientific Institute, Milan), Philip L. De Jager (Brigham and Women’s Hospital, Boston) and colleagues have published their results in the Annals of Neurology (Early online May 14, 2015). The study was supported by the National MS Society and several other agencies.
Background: For reasons that are unclear, some people with relapsing forms of MS do not respond well to therapy and continue to experience disease activity despite being on a disease-modifying therapy. Previous genetic studies in MS have uncovered over 159 genetic variations that contribute to making people susceptible to developing MS, but these studies haven’t identified genetic variations that influence how a person responds to treatment. Finding a way to identify early in the disease course the best therapy for an individual – a “personalized medicine” approach – is likely to improve outcomes of treatment and quality of life for people living with MS. One of the lead authors of this study, Dr. De Jager, recently won the Barancik Prize for Innovation in MS Research for tackling critical questions like this with the goal of developing personalized treatments and prevention of MS.
This Study: Trying a different approach to search for genetic influences on treatment responses, the investigators first studied a group of individuals with MS who were taking interferon beta or glatiramer acetate. The individuals were classified as being responders, partial responders, or non-responders to their medication based on specific criteria. Then the researchers analyzed their full complement of genes (genome-wide association study) and found one genetic variant that was consistently associated with lack of response to interferon beta. When the researchers repeated this in three other groups of people with MS from Italy, France and the U.S., this finding held up.
The genetic variant (rs9828519) is near a gene (SLC9A9) that controls pH levels (acidity) within cells. The team explored functions of this gene, and found that its activity was diminished in people more likely to have MS relapses. They also conducted laboratory work, finding suggestions that the gene appears to play a role in regulating immune cell activity, and that its loss leads to damaging immune reactions. This suggests the gene may play a broader role in regulating immune activity.
Comment: Although the results of this study are not yet ready for applying to the management of MS, this discovery may lead to new approaches for stopping inflammation and immune attacks in MS. In addition, this study is an important step toward the goal of personalized medicine. The researchers point out that additional research is warranted to confirm their findings and to determine whether the genetic variant is relevant to how well people respond to other MS medications.