From FDA approvals to availability and safety, generic drugs are a popular topic in the PatientsLikeMe MS forum (more than 15 threads!). To help you stay in the loop about what generics are and what’s out there for MS, we checked in with our team of in-house health professionals. Here’s the scoop…
Let’s start with the basics: What are generic drugs?
According to the FDA, “a generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics.”
So what sets the brand-name versions apart?
Generic and brand-name medications work the same way and provide the same clinical benefit. Generic medications have the same active ingredients as brand-name medications, but generics only become available after the patent expires on a first-of-its-kind (brand name) drug.
- Ampyra (dalfampridine), the only FDA-approved drug indicated to improve walking in adults with MS, is anticipated to have generic versions available sometime in summer 2018.
Currently available MS generic drugs:
- Glatopa: Glatopa 40 mg/mL is an FDA-approved generic version of Copaxone 40 mg/mL for patients with relapsing forms of MS. Glatopa has been determined by the FDA to be therapeutically equivalent to three times-a-week Copaxone, and is a fully-substitutable medication. Glatopa is available by prescription.
- Glatiramer acetate: 20 mg/mL (daily) and glatiramer acetate 40 mg/mL (3x weekly). These two FDA-approved injections are also generic versions of Copaxone, and can be expected to be as safe and clinically effective. Both are available by prescription.
On the horizon:
- Gilenya‘s patent is set to expire in 2019, opening up the path to generic versions soon after.
Want to learn more about what members are saying about their experiences with generic MS medications? Join the conversation on PatientsLikeMe.
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