FDA approves biosimilar to Lucentis
The US Food and Drug Administration has approved ranibizumab-nuna (Byooviz), a biosimilar to ranibizumab (Lucentis), for the treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV), according to a company press release.
This is the first ophthalmology biosimilar approved in the United States.
Approval was based on data from a randomized, double-masked, parallel group, multicenter phase 3 study in 705 patients with wet AMD assigned to receive SB11 or reference ranibizumab in monthly injections (0.5 mg). Treatment up to 48 weeks was continued in 634 patients.
From baseline to week 52, least squares (LS) mean change in best corrected visual acuity (BCVA) was 9.79 letters and 10.41 letters for SB11 and reference ranibizumab, respectively. LS mean change in central subfield thickness (CST) was −139.55 μm and −124.46 μm for reference ranibizumab.
Safety was comparable at all timepoints up to week 52 between SB11 and reference ranibizumab.
“We are very excited to be able to open a new chapter with the approval of Byooviz in the US. This approval represents a great step toward the advancement of a new therapeutic option addressing debilitating disease progression of patients with retinal vascular disorders in the US,” said Ian Henshaw, Senior Vice President and Global Head of Biosimilars at Biogen, in a press release. “Biosimilars could help broaden patient access to more affordable treatments and generate healthcare savings to offset rising costs of these complex diseases while ensuring sustainability of healthcare systems.”
Read the full press release here.