Ranibizumab Biosimilar FYB201 Provides Similar Efficacy, Safety in Phase 3 Trial

Steffen Schmitz-Valckenberg, MD

Ranibizumab biosimilar candidate FYB201 provided similar efficacy and safety to reference ranibizumab in treatment-naïve neovascular age-related macular degeneration (nAMD), according to new findings.

In data from the COLUMBUS-AMD trial presented at the American Academy of Ophthalmology (AAO) 2021 Meeting in New Orleans this week, the Bioeq and Formycon product was shown to provide similar efficacy, safety, immunogenicity, and quality-of-life (QoL)-associated impacts as ranibizumab in patients newly diagnosed with nAMD.

Steffen Schmitz-Valckenberg, MD, of the Department of Ophthalmology at University of Bonn in Germany, and colleagues conducted the COLUMBUS-AMD study to observe the clinical equivalence of the investigative biosimilar to reference ranibizumab. FYB201 contains the same composition, strength, route of administration, dose and storage conditions as ranibizumab.

“Intravitreal injection of ranibizumab, a VEGF-A-inhibiting biologic, is a well-established first-line treatment for patients with nAMD,” Schmitz-Valckenberg and colleagues wrote. “The high cost and treatment burden of monthly ranibizumab injections may limit real-world treatment outcomes.”

The 48-week, prospective, blinded, parallel-group, randomized, global phase 3 trial included patients aged ≥50 years old with treatment-naïve subfoveal choroidal neovascularization (CNV) due to nAMD. The primary endpoint was change in best corrected visual acuity (BCVA) at 8 weeks from baseline, while secondary endpoints included pharmacokinetics, safety, immunogenicity, and vision-related QoL.

Investigators assessed the biosimilarity of FYB201 to ranibiziumab via a 2-sided equivalence test; equivalence margin was defined as BCVA within 3 ETDRS letters.

Patients were randomized 1:1 to either FYB201 (n = 238) or ranibizumab (n = 239) 0.5 mg every 4 weeks.

Schmitz-Valckenberg and colleagues observed mean BCVA improvement in both groups: 5.1 letters gained at 8 weeks in the FYB201 arm, and 5.6 letters gained in the ranibizumab arm (difference, -0.4; 90% CI, -1.6 to 0.9). The primary endpoint was endpoint, as the 90% confidence interval was withing the predefined noninferiority equivalence margin.

Adverse events occurred in 64.7% of patients treated with FYP201, versus 69.9% of patients treated with ranibizumab; drug-related events occurred in 8.4% and 10.5% of patients, respectively.

Investigators additionally observed similar rates of immunogenicity response and improvements in vision-related QoL scores. They concluded that the biosimilar may offer a “new, high-value treatment option” for patients with nAMD.

The study, “Clinical Efficacy and Safety of Proposed Biosimilar FYB201 Compared to Reference Ranibizumab in Neovascular AMD,” was presented at AAO 2021.