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  • Kenneth Makus

Questions without answers? What are biosimilars? The changing world for Gilenya and Copaxone.

Hello all, a common but one difficult question to answer is: "How good are the generic drugs?" Technically, if the drug is a biologic agent, a generic is called a biosimilar. Below are several articles on biosimilars. The second article is actually a talk and as such you need to scroll down to understand what biosimilars are.


https://mymsaa.org/news/issues-generic-versions/


https://brainxchange.ca/getattachment/Public/Events/Upcoming-Events/MS-Society-of-Canada-Event-The-Evolving-Landscape/The-Evolving-Landscape-of-MS-Treatment_MS-Canada_May-2018.pdf.aspx


We do have good information on Glatect which does inspire confidence. See the following link.


https://www.cadth.ca/sites/default/files/cdr/complete/SE0510_complete_Glatect-Jul-27-e.pdf


For those who have trouble sleeping at night, the following might help. It is a detailed discussion of biosimilars.


https://link.springer.com/article/10.1007/s40120-019-0145-0




I am, of course, keen to save money for our healthcare system as well. The problem with generic manufacturers is that they almost, without exception, do not come to visit as us MS doctors, (the Glatect team is an exception) and as such we do not have information as to the various generics. This is particularly true for Gilenya. The challenge with MS is that it is not like epilepsy. I recall switching one patient with epilepsy to a generic and he had a seizure. Monitoring a patient with MS is more complex.


The question, of course, is how to proceed. For the moment I do not think we are left any options but to switch to biosimilars. Payers are not giving us an option. However, generic manufacturers do have to follow certain guidelines. My preference, if possible, is to maintain patients on the brand but at the same time, I do want to be fair to the biosimilar products as well. We are assured by the regulators that there is no substantial difference. The reality is that I will be monitoring my patients who are switching to biosimilars more closely. Ultimately, I would suggest that you discuss this issue with me in more detail at your next appointment. For those who have no option but to switch to generic, I do think that scientifically, there is a good chance there will be no difference, but please stay in contact with me as to any difficulties you encounter.

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