Ranibizumab Biosimilar XSB-001 Has Similar Safety Profile to Reference Product

Ranibizumab biosimilar XSB-001 (Xbrane Biopharma), has similar visual acuity (VA) outcomes to the reference product for patients with neovascular age-related macular degeneration (nAMD) through 52 weeks of treatment, according to the results of a clinical trial, an analysis of which was published in Ophthalmology Retina.

The multi-center phase 3 trial XPLORE (ClinicalTrials.gov Identifier: NCT03805100) shows the ranibizumab biosimilar XSB-001 exhibited biosimilarity in anatomical, immunogenic, pharmacokinetic, and safety parameters during 52 weeks of 4-week fixed interval treatment. This study was conducted from April 2019 to November 2021,

At clinics in 15 countries, 582 patients (mean age, 74.1 years) with recent diagnoses of subfoveal choroidal neovascularization linked to age-related macular degeneration (nAMD) were randomly assigned to receive either 0.5 mg (0.05 mL) of ranibizumab biosimilar XSB-001 (n=292) or reference ranibizumab (n=290). Investigators defined the main objective as 8-week change in best-corrected visual acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Initial BCVA of those undergoing biosimilar injections averaged 61.7 letters vs ranibizumab recipients’ 61.5 letters.

At 8 weeks, the least squares (LS) mean spherical equivalent (SE) BCVA improvement was 4.6 (0.5) letters with the ranibizumab biosimilar XSB-001, compared with 6.4 (0.5) letters for reference ranibizumab. Thus, the -1.8 letter difference fell within a predefined equivalence range of -3.5 to +3.5 ETDRS letters, including 2-sided 90% CI in the US or 95% CI in other countries. After 52 weeks, LS mean SE BCVA increased to 6.4 (0.8) letters with the biosimilar treatment compared to 7.8 (0.8) letters for referenc ranibizumab, a -1.5 (1.1) letter difference.

The ranibizumab biosimilar and its reference also yielded similar outcomes regarding central foveal thickness, CNV leakage area, and subretinal fluid. Pharmacokinetic data for 40 individuals receiving XSB-001 and 29 with ranibizumab were also comparable, as was anti-drug antibodies (ADAs) in the safety set. The percentage of treatment-related adverse events was 67.5% with XSB-001, 70.6% for ranibizumab.

Reference ranibizumab produced slightly better BCVA results. “These between-group differences in BCVA did not increase over time, were all less than 3 ETDRS letters, and were similar to those observed in previous large clinical trials of nAMD,” the investigators explain.

A somewhat racially non-diverse sample may have limited this trial. Biosimilar medications are typically lower in cost and could increase access to care for nAMD.

Disclosures: This study was supported with funds from Xbrane Biopharma and Bausch + Lomb. Two investigators have disclosed affiliations with biotechnology and pharmaceutical companies. Please see the original reference for complete disclosures.