FDA approves Lucamzi™ - biosimilar to Lucentis®

American ophthalmologists and their patients will soon have a cost-effective treatment option for neovascular (wet) age-related macular degeneration (AMD) and other serious eye conditions after the US Food and Drug Administration (FDA) approved Lucamzi™ (ranibizumab-blrz) as a biosimilar to Lucentis^® . The FDA rigorously reviews biosimilars based on the totality of the evidence presented by the sponsor, “so that healthcare providers and patients can be confident of their safety, effectiveness, and quality”. For Lucamzi, this evidence included a comprehensive comparative analytical assessment at a structural and functional level as well as a Phase 3 clinical study that demonstrated equivalent efficacy and comparable safety to the reference product in 582 patients with wAMD. Xbrane is now, together with its partners, finalizing preparations for the commercial launch of the biosimilar in the United States.

“FDA approval of Lucamzi is a landmark event for Xbrane, representing a key opportunity to reach many more patients and to realize a return on our development investments,” commented Martin Åmark, CEO of Xbrane Biopharma.

Ranibizumab is an anti-VEGF (vascular endothelial growth factor) drug for treating retinal vascular disorders, which are a leading cause of blindness globally. Around 20 million people in the US are living with AMD, with an age-standardized prevalence of 5,677 per 100,000 people. The total economic burden of late-stage AMD in the US is estimated at between $49.4 billion annually, based on a mid-value prevalence rate. Increased biosimilar competition on ranibizumab, such as through Lucamzi, provides cost-effective options to provide equivalent therapy at lower prices, thereby reducing US healthcare costs and improving patient access. Anti-VEGFs for retinal disorders constituted a market of approx. €9 billion of annual net-sales with approx. 10 million injections annually.