Post-Market Surveillance of Biosimilars


Carl D. Regillo, MD, and Jennifer I. Lim, MD, review the regulatory oversight process regarding biosimilars after they have entered the market.

Carl D. Regillo, MD: We know of one FDA-approved biosimilar, ranibizumab, or brand Lucentis, being the reference product. We have a biosimilar, SB11, that is now commercially launched. We have others, potentially FDA approved, at least 1 other, within the next year or so. We need to get familiar with all this. We’re going to have to get comfortable. Once it’s launched and it’s in our hands, is there a surveillance program? And is it the same [for] the reference product?

Jennifer I. Lim, MD: The FDA has held them to a high bar. They have to hold them, in terms of the safety and the production, because these are biological living cells producing these biosimilars. They must make sure that the purity of the drug and the standard are maintained. There’s going to be very high surveillance looking for intraocular inflammation or other side effects. In particular, they’re looking for, 1, what are the side effects with the biosimilar that are being reported and compare them to the reference drug, and secondly, to make sure that the AEs [adverse effects] attributed to the reference drug are not attributed to the biosimilar or vice versa, because these names are very similar. When you look at the name, like ranibizumab, there are four letters added after that name to refer to the biosimilar, so those four extra letters. Of course there are going to be trade names, and that will be obvious to everybody when those names come out.

Transcript edited for clarity

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