1. Jul 20, 2021

Ranibizumab biosimilar has comparable efficacy, safety profile to reference product in patients with nAMD

A biosimilar of ranibizumab has a comparable efficacy and safety profile to the reference product in the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD), according to a study undertaken for regulatory purposes. No meaningful clinical difference was found between the biosimilar and reference product.

At week 16, 98.11% of patients in the biosimilar test arm lost <15 letters in visual acuity compared with 100% in the reference arm. At week 24, 99.06% of patients in the biosimilar test arm lost <15 letters in visual acuity compared with 100% in the reference arm.

At least 15 letters in visual acuity till week s16 and 24 were gained in 25.47% and 32.08% and 32.08% and 43.30% of patients in the test arm and reference arm, respectively.

Mean change in central macular thickness at 24 weeks was − 89.93 μm in the biosimilar test arm and − 64.42 μm in the reference arm.

 There was no statistically significant difference for any endpoint at weeks 16 and 24.

Reference
Apsangikar P, Ghadge P, Naik M, et al. Double-blind, comparative clinical study of new ranibizumab biosimilar in neovascular (wet) age-related macular degeneration. Clin Ophthalmol. 2021;15:3087-3095. https://doi.org/10.2147/OPTH.S307746