Proposed Ranibizumab Biosimilar Meets Safety, Efficacy Endpoints for nAMD

Proposed biosimilar FYB201 was found to demonstrate a similar efficacy profile as reference ranibizumab in treatment-naive patients with subfoveal neovascular age-related macular degeneration (nAMD), according to research results presented at the American Academy of Ophthalmology 2020 Annual Meeting, held virtually November 13 to 15, 2020. 

Investigators participating in the COLUMBUS-AMD (Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-Related Macular Degeneration; ClinicalTrials.gov Identifier: NCT02611778) trial sought to compare safety and efficacy outcomes of FYB201 with reference ranibizumab. The primary study endpoint was a 95% confidence interval within -3.5 to 3.5 for the difference in mean change from baseline in best corrected visual acuity at 8 weeks. 

Patients were randomly assigned to receive either FYB201 (n=215) or ranibizumab (n=214) 0.5 mg every 4 weeks for 48 weeks. At 8 weeks, FYB201 was found to be associated with a mean change from baseline in best corrected visual acuity of 5.2 ETDRS letters compared with 6.0 ETDRS letters for ranibizumab (mean difference -0.8; 95% CI, -2.3 to 0.9). Similar efficacy was noted at 48 weeks (mean change, 7.9 and 8.5 ETDRS letters for FYB201 and ranibizumab, respectively). Secondary endpoints, including safety, immunogenicity, and pharmacokinetics, were similar between treatment arms. 

“FYB201 met the primary outcome of similarity to [ranibizumab] for efficacy and safety in treatment-naive nAMD,” the investigators concluded. 

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures. 

Reference

Holz FG, Olesky P, Ricci FU, Kaiser PK, Kiefer J, Schmitz-Valckenberg S. COLUMBUS-AMD: efficacy and safety of FYB201, a proposed biosimilar to ranibizumab, in nAMD. Presented at: American Academy of Ophthalmology 2020 Annual Meeting; November 13-15, 2020. Abstract PO387.