Interchangeability of Biosimilars in Ophthalmology


Michael A. Klufas, MD, discusses the significance of interchangeability of biosimilars and being able to substitute biosimilars for reference products, as well as the path to achieving the designation of interchangeability from the FDA.

Rishi P. Singh, MD: Let’s talk about the interchangeability about the biosimilar a little bit more. How do we know that there is a designation of interchangeability and how does the patient provider feel about that trust and that sort of designation?

Michael A. Klufas, MD: That’s a great question. Personally, interchangeability I think gives physicians and patients a lot of confidence that a biosimilar product can be substituted with the reference product, with no clinically meaningful difference in immunogenetic response, systemic antidrug antibodies, risk of inflammation, things such as this, and you can be confident that you can substitute a particular biosimilar for the reference product in any given patient. The question is how this is achieved. And of course, the FDA gives this designation, and they look at the totality of evidence to demonstrate that the biosimilar is providing the same effect as the reference product, but they also look at additional factors. These include, for instance, that many ranibizumab biosimilars have a relatively low complexity, there’s no glycosylation of these products, that these biosimilars have a low incidence of immunogenicity with the reference product having no history of severe immunogenic responses, and that any serious adverse event or AE is comparable to [that of] the reference product. Putting all these factors together, some biosimilars may achieve the designation of interchangeability from the FDA.

Rishi P. Singh, MD: Yes, I think that that trust issue is something that all of us have become used to seeing in these products. It’s not just that we have a biosimilar in ophthalmology, we have multiple. And we’ll get into that in our next section a little bit about those biosimilars that are approved in terms of some of the data in and around that. We talked about the COLUMBUS trial with our first biosimilar that we’re going to discuss as well. We’ll discuss some of the other ones as we go along as well.

Transcript is AI-generated and edited for clarity and readability.

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