Challenges in Use of Biosimilars in Ophthalmology Practices

EP: 1.Overview of Biosimilars

EP: 2.Approval Process and Quality of Biosimilars

EP: 3.Clinical Studies for Biosimilars in Ophthalmology

EP: 4.CHS-201 and Other Ranibizumab Biosimilars in Ophthalmology

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EP: 5.Challenges in Use of Biosimilars in Ophthalmology Practices

EP: 6.Helpful Hints for Use of Biosimilars in Ophthalmology Practices

Peter Kaiser, MD: When we discuss challenges to the use of biosimilars in ophthalmology, the biggest challenge is trust, so we have been using ranibizumab for many years and the reference ranibizumab and biosimilars are new. We need to trust the FDA and that their analytical studies are appropriate, and the safety is good, but overall, we need to trust that the outcomes will be the same and the clinical studies help us with that trust, but you only develop trust when you actually use something yourself. Over time, as we use this, we will develop the trust we need to use biosimilars.

Antidrug antibodies are something that we’re starting to learn a lot more about. Prior to brolucizumab and the intraocular inflammation that we saw with brolucizumab postlaunch, we didn’t pay attention to antidrug antibodies. Now, it seems that in the patients who are developing intraocular inflammation, a lot of them developed antidrug antibodies, which would explain the intraocular inflammation that they were seeing. What’s interesting is, that for all of our anti-VEGF agents in the clinical studies, antidrug antibodies were seen, both at baseline—so even before patients receive the drug, they could have antidrug antibodies—or even later in the clinical study, they may develop antidrug antibodies. It is important to watch for at baseline how many patients have it, as well as how many patients develop it over time. In all 3 of the clinical studies for biosimilars to date, the phase III studies that have been published, there was no increase in terms of ADA, or antidrug antibodies, in the biosimilar arms versus the ranibizumab reference arms. Even though in ophthalmology we do need to look at antidrug antibodies, at least with ranibizumab and biosimilars, the antidrug antibody production doesn’t seem to be leading to any differences in intraocular inflammation rates.

Transcript edited for clarity