In mid-April, the FDA approved Sandoz’s Glatopa, the first substitutable generic for Copaxone (glatiramer acetate) 20 mg/ml ---an approval that introduced a new dynamic in a category that until this point had been a non-generic, high-cost specialty market. And although Teva has tried to block the FDA’s approval of Glatopa, in, Teva’s patent will expire in September 2015, at which point Sandoz can launch Glatopa.
Almost 19 years earlier, in late 1996, the FDA approved Teva’s Copaxone for treatment of relapsing-remitting multiple sclerosis (RRMS). At that time, it would have been hard to predict how much staying power Copaxone would have. In fact, it was a new specialty drug in a challenging therapeutic area, and like other new drugs, physicians and patients had yet to gain experience with long-term treatment.
However, over the last 18-plus years, Copaxone has proven remarkably effective and tolerable for many RRMS patients. In fact, although a number of new oral therapies have been introduced, Copaxone, which generated $4.2 billion in sales last year, is still relied upon by many neurologists as a safe, effective and tolerable treatment option.
Online discussion group forums for patients with MS are full of ongoing discussions and positive anecdotes about how Copaxone has decreased their RRMS relapse rates and improved quality of life as a result.
Jon Searles, Senior Director, CNS/Ophthalmology at Decision Resources Group (DRG), explains, “Copaxone’s share of the MS market has remained relatively stable. With a disease like MS, when patients are responding well to a specific therapy, physicians are somewhat reluctant to switch to a new medication just for the sake of convenience.”
In fact, Copaxone has continued to be a go-to favorite despite skyrocketing costs--- in the last two decades, the annual cost of treatment has risen from roughly $11,000 per year to $60,000. (LINK) However, the Glatopa approval has signaled what many think will be the beginning of a big evolution in MS therapeutics.
But does the introduction of a generic, presumably cheaper, Copaxone equivalent translate into a rapid shift away from branded Copaxone towards the new generic option? No, not necessarily. According to Searles, physician perception of Glatopa is relatively mixed. He says, “In a survey we fielded in January, one-quarter to one-third of physicians said they would have to be forced to prescribe Glatopa for DMT-naïve patients or patients switching from a branded Copaxone formulation. In those instances, approximately one-third would switch voluntarily, and the remaining respondents were neutral.”
A gradual evolution
Despite the fact that Copaxone is well entrenched, there are factors working in Glatopa’s favor. First, because Sandoz is part of Novartis and Novartis has a strong presence in MS, Novartis reps will most likely be detailing Glatopa and leveraging the company’s existing network of neurologists.
Also, it is a unique, first-in-class type of generic compound. John Crowley, Ph.D., Senior Business Insights Analyst, CNS/Ophthalmology at DRG, says that Glatopa “straddles the space between being a small molecule and being a biosimilar. There is a higher barrier to entry for additional generic versions of glatiramer acetate 20 mg/ml, compared with small molecule generics.”
However, Crowley also points out that MS treatment is highly individualized, which means that formularies will remain relatively static for a while. Nonetheless, there is constant payer pressure across all therapeutic categories and neurology is no exception. He says, “We don’t expect patients currently treated with interferon betas or oral DMTs to be forced to switch to Glatopa when it launches. However, it may be implemented as a step therapy for patients initiating therapy, who may be seeking treatment with those options. We do expect many of the patients remaining on branded Copaxone 20 mg/ml, may face a switch to Glatopa, although this formulation accounts for only one-third of prescriptions for the Copaxone franchise.”.”
Crowley says, “Over time, we expect the injectables platform will continue to decline and the oral treatment options will continue to gain share, due mainly to shifting physician and patient preferences.”
In fact, DataMonitor Healthcare expects that Biogen Idec’s Tecfidera (dimethyl fumarate) to own 25% of the entire MS market by 2021. Even further along, within about five years, the DRG analysts see the entry of generic, oral treatment options.
For now, however, Glatopa represents a unique value play and a new type of product trying to make inroads in a well-established market. The question is not if Glatopa will eventually gain noteworthy market share, but when. Much of the work to be done, will be done by marketers---and they are hard at work right now laying the groundwork for a successful launch.