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The Boxing Match of Copaxone vs. Glatopa

I know almost nothing about boxing except for a few famous names like Muhammad Ali and Joe Louis. I know that boxing matches are in rounds, and the first round begins with boxers sizing each other up, dancing, bobbing and weaving around one another before they throw their first punch.

I think about boxing when I reflect on what’s been happening in MS news regarding Copaxone, the immunomodulator drug for Multiple Sclerosis.

Round One: In MS news regarding Copaxone (the biggest selling Multiple Sclerosis medication) the first round began when Teva Pharmaceuticals first filed and then continued on with eight separate petitions with the FDA to stop production and distribution of generic forms of its drug.

As each petition lingered on in court Teva had the perfect opportunity to market a newer version of their drug. After they received approval for this new injectable, they wooed patients to switch from the task of injecting themselves daily to injecting only three times a week.

Round Two revolves around the patent Teva holds on Copaxone that will not expire until September 2015. This is important because meanwhile, the partnership of Sandoz and Momenta Pharmaceuticals, owners of a generic form of Copaxone called Glatopa, waited in the wings to receive their own FDA approval.

The judicial system ruled that the expiration date for Copaxone was invalid. But in January the Supreme Court asked the appellate court to reconsider its ruling.

According to a New York Times article, “It seems likely that Sandoz and Momenta will wait until that decision before starting to sell their drug, or wait until September if the appeals court upholds the patent.”

Round Three concerns Teva who, in their petitions with the FDA, argued that their medication is so complex with several amino acids of different sizes and sequences that it would be impossible to copy without the possibility of harming patients.

According to an article in The Wall Street Journal, “Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research, took pains to note the generic Copaxone ‘met the same rigorous standards of quality as the brand-name drug. Before approving this generic product, given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand name product.’”

Copaxone was first FDA approved in 1996, and I was among the first throng of patients to use it. After suffering side effects from the first two FDA approved MS medications, Betaseron and Avonex, I was thrilled to have a third injectable to try.

I was lucky to have an insurance plan to cover the cost of almost $9,000 a year for my new medication. Since then prices have almost tripled to over $60,000 a year despite more products entering the market. I say that’s exorbitant.

But wait. So far I’ve discussed boxing, pharmaceutical companies, lawsuits and big business. What’s missing?

The patient.

In terms of a boxing match we, the patients, are sitting on the sidelines helplessly watching the show. As pharmaceutical companies battle it out through the judicial system, we continue to pay exorbitant prices to see the show, or if we don’t have insurance and aren’t qualified for patient assistance programs we can’t even get in the front door.

With the recent announcement of a generic equivalent to Copaxone being FDA approved, and with Mylan, a leading generic manufacturer, and Synthon, a Dutch company, waiting for approval for their Copaxone-equivalent drug, we hold out hope that the more competition there is, the lower the cost will be for all MS medications.

And I hope that newer medications will have fewer side effects for all patients.

I am cautiously optimistic about the new generic form of Copaxone, taking a wait-and-see attitude about the cost, availability and whether there will be any side effects despite the FDA’s statement. After living with MS for 28 years that’s how I now look at things.

And I always keep hope in my heart.

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The MultipleSclerosis.net team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

Comments

  • Dlap01
    4 years ago

    I tried to find any trials for Glatopa and could find none. According to the FDA Copaxone, it is a similar molar weight but even Copaxone varies from batch to batch. I do not want to roast relapse on something that may be close bust has not be tried in trials because it looks close enough. That should be left up to my choice. Read letter nine response to Tevas challenge to FDA. The package info is direct copy from Copaxone..not new research.

  • Laura Kolaczkowski
    4 years ago

    I’m curious to see how insurance companies might react to the generic option – so often we are required to use generics rather than name brand for the cost savings. A few examples might be few people are on Liptor for cholesterol and instead take atorvastatin. Provigil for fatigue is not allowed for me but I can have the generic modafinil. The list goes on and on. The Copaxone – Glatopa option could make an interesting round at the pharmacy.

  • Cathy Chester moderator author
    4 years ago

    That, of course, was brought up in the articles I offered. A lot will depend on the decisions of the insurance companies. We will have to wait and see how this all plays out.

  • north-star
    4 years ago

    Copaxone is my DMT, thanks for the update! If there is a generic version, wonder what the savings will be? I hope users will weigh in on how well it works, or doesn’t work. I’ll do my part when I switch.

  • Cathy Chester moderator author
    4 years ago

    So glad it’s working for you, north-star!! I agree about waiting to see how much the cost is.

    Some users on 3x/week may have a decision between the convenience of not injecting daily, or using a less expensive drug but injecting 7 days/week.

    It may also be up to insurance as well……

  • kitminden
    4 years ago

    I wonder what the generic will be priced at and whether that will be affordable.

  • Cathy Chester moderator author
    4 years ago

    That’s a great question, Kit.

    Since the prices are not regulated for the other meds it’s an open field to how generics will be priced. You should read the articles I referenced from the NY Times and Wall Street Journal. They provide more information about this issue.

    In the meantime we both need to hope that better medications are on the horizon at lower costs to us, as well as less or (dare I say it?) no side effects.

    PS My husband just told me that Teva is acquiring Mylan, the generic company I referenced above that has a generic form of Copaxone. What will that mean? Stay tuned.

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