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FDA Approves Another New Generic Form of 40mg Copaxone®

February 15, 2018

  • The U.S. Food and Drug Administration has approved a second generic form of 40mg glatiramer acetate injection, called Glatopa® (Sandoz). This is a generic form of 40mg Copaxone® (Teva Pharmaceutical Industries LTD), taken three days per week by injections under the skin to treat relapsing forms of MS.
  • A 20mg formulation of daily Glatopa was previously approved in 2015, so now Glatopa will be available in both 20mg and 40mg formulations.
  • The approval means that Sandoz provided evidence that the generic medication is equivalent to the brand-name Copaxone. 
  • There is no information yet about when the 40mg Glatopa will become available for prescription, or what it might cost.
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 a generic glatiramer acetate medication that has been shown to be equivalent to the 40mg Copaxone taken three days per week 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. 
Through the GlatopaCare® program, qualified individuals will be offered $0 co-pay support program, and the company provides personalized injection training, 24-hour access to nurses for Glatopa-related questions and other services. For more information about Glatopa, individuals may call the company at:
  • 1-855-GLATOPA (1-855-452-8672)
The National MS Society will provide more information about this generic form of glatiramer acetate, including its cost, as it becomes available.
Download prescribing information about Glatopa (.pdf)
Read more about disease-modifying therapies and other treatments for MS and MS symptoms

Frequently Asked Questions: Approval of New Generic of Copaxone

When will the new generic therapy be available for prescription?
There is no information yet about when this medication may be available in the United States. Other forms of generic Copaxone are already available.
What will the generic 40mg glatiramer acetate from Sandoz cost?
There is no information yet about the cost.
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 days per week.
What about insurance coverage for a generic 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 generic forms 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 40 mg generic from Sandoz?
Yes, the company has will provide services through its Glatopacare program, which can be contacted at 1-855-GLATOPA (1-855-452-8672)
Copaxone is a registered trademark of Teva Pharmaceutical Industries LTD
Glatopa and Glatopacare are registered trademarks of Novartis AG

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.