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?
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.