Key Takeaways
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The FDA approved Lucamzi (ranibizumab-blrz) as a biosimilar to Lucentis, with a US launch planned for 2027
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A phase 3 study involving 582 patients with wet AMD demonstrated equivalent efficacy and comparable safety to the reference product
The FDA has approved Lucamzi (ranibizumab-blrz), developed by Xbrane Biopharma, as a biosimilar to Lucentis (ranibizumab), providing another anti-VEGF treatment option for patients with wet age-related macular degeneration (AMD) and other retinal vascular diseases.
Xbrane and its commercial partners are finalizing preparations for a planned US launch in 2027.
Ranibizumab is an anti-vascular endothelial growth factor (VEGF) therapy used to treat retinal vascular disorders. The approval was supported by a comparative analytical assessment of the biosimilar's structural and functional characteristics, along with results from a phase 3 clinical trial involving 582 patients with wet AMD. The study demonstrated equivalent efficacy and comparable safety between Lucamzi and the reference product, according to Xbrane.
“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,” said Martin Åmark, CEO of Xbrane Biopharma.
The company highlighted the potential economic implications of expanded biosimilar competition in the retinal disease market. According to Xbrane, approximately 20 million people in the United States are living with AMD, and the annual economic burden of late-stage disease is estimated at $49.4 billion. Xbrane also estimated that anti-VEGF therapies for retinal disorders represent approximately €9 billion in annual global net sales, with roughly 10 million injections administered annually.
