2 posts tagged “drug development”

The lowdown on generic MS medications

Posted March 6th, 2018 by

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.

Coming soon:

  • 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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From preclinical to approval: How clinical trials bring new treatments to market

Posted September 15th, 2017 by

Often we hear of new treatments becoming available, but have you ever wondered what each new treatment had to go through to get approved by a regulatory body like the FDA? Before a new treatment is approved for commercialization, it needs to go through a meticulous trial process to prove a number of things: Is the drug safe? What are the potential side effects? Does the drug do what it’s supposed to do? All of these questions and more need to be answered before a drug can be considered for approval by the FDA, so that’s where clinical trials come in. Here’s a breakdown of what’s involved in the drug development process, from preclinical through to commercialization and post-approval monitoring.

(Click to enlarge)

How can I participate in a clinical trial or find out more?

  • You can learn more about research and clinical trials by joining or logging into PatientsLikeMe and clicking on the Research tab
  • Use the PatientsLikeMe Clinical Trial Finder to search for trials that could be a good fit for you
  • Check in with local associations and hospitals to see if they are recruiting for any trials
  • Talk to your healthcare provider/clinician to see if there are opportunities they are aware of and how you can participate
  • If you’re a member of PatientsLikeMe, make sure you consistently update your profile so we can let you know about research survey opportunities that are right for you

Interested in finding out more about how PatientsLikeMe members are impacting change in the clinical trial sphere? Check out these stories:

It’s Clinical Trials Day, and patients are driving change

“My expertise is as a person with Parkinson’s”: Member Lisa brings the patient voice to drug development

Bringing the patient voice to clinical trials

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