NEW YORK, Oct. 4 -- The National Multiple Sclerosis Society issued the following news:
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(R) (Teva Pharmaceutical Industries LTD), taken every three days 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(R) (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 every three days 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)http://newsroom.mylan.com/download/Glatiramer+Acetate+40+mgmL+Patient+Information+Prescribing+Information.pdf
Download prescribing information for Mylan's 20mg glatiramer acetate (.pdf)http://newsroom.mylan.com/download/Glatiramer+Acetate+20+mgmL+Patient+Information+Prescribing+Information.pdf
Read more about disease-modifying therapies and other treatments for MS and MS symptomshttp://www.nationalmssociety.org/Treating-MS/Medications
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 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.
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
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