CHS-201 and Other Ranibizumab Biosimilars in Ophthalmology

EP: 1.Overview of Biosimilars

EP: 2.Approval Process and Quality of Biosimilars

EP: 3.Clinical Studies for Biosimilars in Ophthalmology

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

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 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