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FDA Approves Two New Generic Forms of Copaxone® (Glatiramer Acetate)

October 4, 2017

UPDATED 10/6/2017
  • The U.S. Food and Drug Administration has approved the first generic form of 40mg glatiramer acetate injection, produced by Mylan. This is a generic form of 40mg Copaxone® (Teva Pharmaceutical Industries LTD), taken three times per week by injections under the skin
  • The agency also approved Mylan’s generic for the daily 20mg dose. This is the second approved generic for glatiramer acetate 20mg. Glatopa® (Sandoz), became available in June 2015.
  • These approvals mean that Mylan provided evidence that these generic medications are equivalent to the brand-name Copaxone.  
  • There is no information yet about when these generics will become available for prescription, or what they might cost.
“Having additional generic options has the potential to increase affordability of and access to MS disease-modifying therapies,” commented Dr. Bruce Bebo, Executive Vice President, Research at the National MS Society. “Early and ongoing treatment with FDA-approved MS disease modifying therapies is currently the best way we know to reduce future disease activity for people with relapsing forms of MS,” he added.
 
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.
 
More Details: The FDA has approved generic medications that have been shown to be equivalent to both the 40mg glatiramer acetate taken three times a week and the 20mg taken daily by subcutaneous (under the skin) injections. 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. 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. 
 
The National MS Society will provide more information about these generic forms of glatiramer acetate as it becomes available.
 
Download prescribing information for Mylan’s 40mg glatiramer acetate (.pdf)
Download prescribing information for Mylan’s 20mg glatiramer acetate (.pdf)
Read more about disease-modifying therapies and other treatments for MS and MS symptoms

 

Frequently Asked Questions: 

Approval of Generics of Glatiramer Acetate

When will these new generic therapies be available for prescription?
There is not information yet about when these medications may be available in the United States. Glatopa, a generic for daily glatiramer acetate, has been available since 2015. 

What will the generic glatiramer acetates from Mylan cost?
There is not information yet about the cost of these generics. 

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

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.

Do these generic 40mg and 20mg doses have the same therapeutic benefit as 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 this new generic from Mylan?
At this point we do not have specific information on support services, but Mylan has announced its intention to provide this type of support through the Mylan MS AdvocateTM patient support services. When additional information becomes available, we will provide updates. 

Copaxone is a registered trademark of Teva Pharmaceutical Industries LTD
Glatopa is a trademark of Novartis AG
Mylan MS Advocate is a trademark of Mylan

FAQs About Generic and Biosimilar Medications

The following provides information about generic drugs and biosimilars 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 “bioequivalence”). 
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 treatment options. 
Does the National MS Society recommend the use of these new generic MS therapies?
  • 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, Ocrevus, Plegridy, Rebif, Tysabri and Zinbryta -- are technically classified as “biologics” or “biological products.” 
What is different about biologics?
  • Biologics are generally more complex and they are made from human or animal materials rather than chemical processes. The technical term for an equivalent medication for a biologic is “biosimilar” or “follow-on biologic.” 
How are biosimilar products evaluated by the FDA?
  • The FDA will only approve a biosimilar product if it has the same mechanism of action, route of administration, dosage form, and strength as the reference product. Additionally, a biosimilar can only be approved for the indications and conditions of use that have been previously approved for the reference product.
  • Under a law passed in 2009, a biological product may be demonstrated to be biosimilar if data show that:
    • the product is highly similar to the already-approved biological product;
    • it has no clinically meaningful differences in terms of safety, purity, and potency from the reference product; the proposed biosimilar is expected to produce the same clinical result.
What is the current progress toward developing equivalent medications for MS therapies?
  • The FDA has approved three generic forms 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.
 

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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