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.
The PatientsLikeMe team has been traveling around the globe recently talking about the power of real-world patient data in changing healthcare. You may have heard about our executives at industry conferences, government hearings, or even on TV. Highlights below.
Last month, PatientsLikeMe Co-founder and President Ben Heywood was on Fox Business News talking about how industry is engaging directly with patients and tuning into the “unvarnished truth” patients are sharing about their real-world disease experiences.
Listen | Ben Heywood (Co-founder, President) answers questions about the launch of our new organ transplants community and our collaboration with Novartis
Listen | David S. Williams III (Chief Marketing Officer) shares industry best practices in using social media for clinical trial recruitment (recently presented at the CHI SCOPE conference)
Listen | Paul Wicks Ph.D. (R&D Director) discusses nexus of personalized medicine and information technology (highlights from his presentation given at a Personalized Conference event by ASU, Mayo Clinic, AAAS, FDLI)
Listen | Jamie Heywood (Co-founder, Chairman) visits “on call” to talk about the impact of real-world experience on drug safety
Listen| Sally Okun RN (Health Data Integrity Manager) gives her perspective on improving patient engagement and fostering patient-provider partnerships through tools like the Doctor Visit Sheet (highlights from her presentation at the Patient E-Centered Health event by The Stevens Institute of Technology)
Watch | Maureen Oakes (Product Manager) shows you cool new website functionalities making their debut with the new transplants community
Watch | Paul Wicks Ph.D. (R&D Director) talks about the value of patients measuring quality of life through online patient-reported outcome