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Vivian Bykerk, MD: Using Biosimilars in Treating Patients


Vivian Bykerk, MD, associate attending rheumatologist at the Hospital for Special Surgery, associate professor of medicine at Weill Cornell Medical College, describes her level of comfort with using biosimilars in practice.


Are you comfortable with using a biosimilar for your patient?

I’m comfortable in starting my patient on a biosimilar versus its originator, assuming that it works equally well, that there are no glitches in access, and that the federal government has inspected the makers of that biosimilar as much as they inspect the originators, because I know there is a whole process of compliance and specifications that needs to happen.

I worry that they’re able to do that if they’re made in India or Korea or wherever. I’m not so worried about the biosimilars that are made in this country by the companies that are already making them in this country, because we know there are differences, so I would want to see very careful inspection of the company or manufacturing plants that are making them.

So, let’s assume all of that is the case and the process of accessing the biosimilar is equal to the process of accessing the originator, so you don’t end up with short falls—the needle works as well, the boxes are similar, all of the practical considerations—I think it would be fine.

What I do not want to see is people being forced off of their drug that works, or multiple switching. Even worse, I don’t want to see multiple switching where I’m not told or the patient is not told. For that matter, I don’t want to see [any] switches [at all] where I’m not told or the patient isn’t told.

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