Aliza Ben-Zacharia Provides Insight on Biosimilars for Treatment of Patients With MS

Biosimilars have the potential to reduce costs of treatment for patients with MS, but until clinical trials show their efficacy, clinicians will feel uneasy about prescribing them for chronic illnesses, said Aliza Ben-Zacharia, DNP, ANP, associate director at the Center for Nursing Research and Innovation at Mount Sinai.

Transcript

Could biosimilars of some biologics that treat MS play a role in reducing the cost burden for patients with MS?

I feel uncomfortable when insurance insists on patients getting a biosimilar medication. We just started and I'm sure in the future we'll have other biosimilars and other generic medication to be used in MS to reduce the cost. The question is: are they equally effective? I think that's what we all struggle in clinical practice. Patients ask us many questions: is this okay for me to go on this generic? What if I'm not doing well? I think the fact that there were no clinical trials, but that's how generics are. They look at the biosimilar, they look at the structure, and again, I think that—for example, as I as I mentioned, glatiramer acetate is such a unique mechanism of action. It's really a very tricky thing that looks at sequencing of amino acid, and if you get a batch now and get another batch in a month or 2 months, it might be a little different than the 1 you receive. So, I think it's just a smart mechanism of action–how can you biosimilar such a thing? So, that's number 1.

Number 2, I think it's uncomfortable for me and for my college to prescribe something that was not really involved in a clinical trial—didn't look at patient, wasn't tried in patients, and shown to be effective in patients–even with MRI data. So, 1 of the companies that have generic glatiramer really did some study with MRI, and I think that that's okay–as long as they have some data to tell us that it can control the progression of MS. Again, it's a debilitating and disabling chronic illness so you want to stop the progression, you want to minimize risk of relapses, you want to maintain good quality of lives, and I think what's really important here, to show some data. It doesn't have to be 3000 patients, doesn't have to be 2 phase 3 trials–as we do with new medication, but it should have some clinical trial. I think the FDA should come with that policy and say for any generic and biosimilar, we need to have some kind of a pilot study or a mini study that showed the efficacy. I think once that’s being done, clinicians will feel much more comfortable telling the patient: okay, you can go on a biosimilar and you can take this medication, you'll have the same effect, and we’ll monitor you. That's what I did today–I monitored these patients vigilantly just to make sure that they're doing well.

If there is any breakthrough, then at least that's allowed. We do that very often—if they didn't tolerate the drug and if there is a breakthrough disease, the insurance will allow the patient to go to the brand name medication; but, I must admit it's an uneasy situation when you know this combination by a biosimilar medication did not go through any clinical trials and I'm just giving something based on some work in the lab and that's it. In a lab that's different than the original lab that actually created this new molecule. I think many clinicians feel that way. Although we want to reduce the cost, and the National MS Society always speaks about generic medication and biosimilar–that's the way they say to reduce costs. I think the future will tell. Nowadays, I have quite a number of patients on biosimilars, so we'll see what happens in the future.