Researchers see success in trial for first generic MS drug, paving way for more development

For the first time, a generic version of a popular drug for multiple sclerosis (MS) was found to be safe and effective— which may set precedent for generic drug development for MS patients.

In new trial results presented Friday morning by the Cleveland Clinic, researchers studied a group of 735 patients with relapsing-remitting MS for nine months. The double-blind trial compared the popular MS drug Copaxone with a generic version. In both treatment groups, a comparable number of patients were free from disease activity and the disability was stable. Currently, there are no generic drugs available for patients with MS.

According to the National Multiple Sclerosis Society, relapsing-remitting MS is a form of the central nervous system disorder characterized by clearly defined attacks of worsening neurologic function. Patients experience attacks, often called relapses, followed by partial or complete recovery periods, or remissions. About 85 percent of MS patients are initially diagnosed with this form of the disease, compared to 10 to 15 percent who have progressive forms.

Copaxone works by tricking the immune system into not attacking the nervous system, which is one of the characteristics of MS. The medication has been effective and well-tolerated, but while it controls the abnormal immune response— which is true of all currently available medications for MS— there is no cure for the disease.

The findings are significant because drug costs are a sizable portion of the cost of MS care, lead study author Dr. Jeff Cohen, director of the Cleveland Clinic Mellen Center for Multiple Sclerosis, told

“Now that several [medications] are going off patent, it gives the opportunity to develop generic versions,” he said. “MS medications, like for a lot of diseases, are very expensive, so the hope would be these generics would provide alternatives that are equally safe and effective, but at a lower cost… to both payers and patients.”

Because clinical trials are costly, Cohen noted that the conditions under which they’re conducted are an important issue in the development of generics. Requirements for testing should neither be too relaxed— which could jeopardize benefit or safety— or too stringent— which could become too expensive, disincentivizing companies from developing generics, he said.

“Unlike what are so-called ‘small’ molecule [drugs]— aspirin, acetaminophen—for large, very-complicated molecules [in MS drugs], relatively small changes in how they’re manufactured conceivably could make a major difference in either safety or benefit,” he said.

Researchers used magnetic resonance imaging (MRI) to show efficacy of the generic drug. Typically, testing for new MS drugs includes MRI, but also requires more patients and a longer study period— all of which are costly. Because MRI is able to detect MS activity in a very sensitive way, researchers believe it is sufficient for generic drug testing. The European Medicines Agency (EMA), allows MRI testing alone, but the Food and Drug Administration (FDA) does not.

“If you held generics to the same standards [as a new drug], it would be too expensive, there’d be no incentive for a company to make,” Cohen said. “The whole point of a generic, ideally, is to have less testing and to be priced lower. Using MRI as an endpoint in a generic study for a drug already existing might be sufficient.”

The study was designed in discussion with the EMA, but because the FDA has yet to release its final policies and guidance on complex generics, the next step with these findings is unclear, Cohen said. If the results are approved by the EMA, the generic could be available in Europe in the next year, but for the U.S., the timeline is less certain.

Researchers hope their findings will encourage other scientists to develop generic drugs for MS treatment.

“[We] hope as generics become available as a reasonable alternative, it will increase the availability of treatment,” Cohen said. “…Hopefully this will lead to some cost savings.”