CHS-201 and Other Ranibizumab Biosimilars in Ophthalmology


Dr Peter Kaiser provides an overview of biosimilars that are either approved or are being developed for treatment of retinal diseases.

Peter Kaiser, MD: When we look at biosimilars in ophthalmology, we have an FDA-approved biosimilar. It was formally called SB11, but now it's called ranibizumab-nuna. We also have 2 biosimilars to ranibizumab that are currently in front of the FDA. One is CHS-201/ FYB201, which is in front of the FDA, and a second called Lucane, and there's not yet a 4-digit name for either of these 2 because you only receive that designation after you get FDA approval. In addition, there are 2 or 3 other companies looking at ranibizumab biosimilars that are currently in clinical trial phases. It's an exciting time in ophthalmology because we have 1 approved and, hopefully, 2 more biosimilars to ranibizumab coming very shortly.

When we look at the clinical studies for CHS-201/FYB-201, the clinical study was performed in patients with neovascular age-related macular degeneration [AMD]. The primary outcome was at 4 weeks and 8 weeks in the United States. The 8-week visual acuity had to be noninferior to reference ranibizumab. In both treatment groups, the treatment was exactly the same in that the patients were randomized 1 to 1 to receive either reference ranibizumab or CHS-201 on a monthly basis with the primary outcome at week 8. The primary outcome was met in that the results of patients receiving CHS-201 were noninferior to those of patients receiving the reference ranibizumab with a difference between the groups of less than 1 ETDRS letter, so very, very similar. In addition, when you look at the safety of the drug at 1 year, the amount of neutralizing antibodies, the amount of adverse events, and the number of patients who had intraocular inflammation, was also noninferior between the 2 groups. When I look at a clinical study for biosimilars, I look very closely at the safety, so the adverse events as well as the treatment emergent adverse events. In both of those categories between the 2 treatments, there was essentially no difference. I was very excited about both the safety and the efficacy of CHS-201 vs reference ranibizumab in its phase 3 clinical study in wet AMD.

When we look at the recently FDA-approved ranibizumab biosimilar ranibizumab-nuna, which was formerly known as SB11, they also performed a clinical study in patients with wet age-related macular degeneration, randomizing patients to ranibizumab-nuna vs reference ranibizumab in a 1 to 1 treatment paradigm with the primary outcomes being central subfield thickness being noninferior at week 4 and each DRS [digital retinal imaging] visual acuity being noninferior at week 8. Similar to FYB201/CHS-201, ranibizumab-nuna was not inferior to reference ranibizumab in either OCT [optical coherence tomography] outcomes at week 4 and the ETDRS visual acuity outcomes at week 8. As one would hope, the visual acuity outcomes were maintained through 1 year of the studies for 52 weeks, and the adverse event profiles were also similar between the 2 drugs. When I look at the results of the COLUMBUS-AMD study [NCT02611778], which was the biosimilar FYB201 vs SB11, the already approved biosimilar ranibizumab-nuna, the outcomes were the same. As you would hope, in that the patients did well from an efficacy standpoint, being not inferior, and safety was excellent between the 2 drugs. I wouldn’t think or pretend to think that there is any difference in outcomes at this point. Obviously, with additional pharmacovigilance, we’ll see if there is any difference long-term.

Transcript edited for clarity

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