STOCKHOLM, Sweden, June 3, 2026
Xbrane Biopharma AB has reached a significant regulatory milestone after the U.S. Food and Drug Administration (FDA) accepted the resubmitted Biologics License Application (BLA) for Lucamzi™, the company’s investigational biosimilar candidate to LUCENTIS® (ranibizumab). The FDA has assigned a Biosimilar User Fee Act (BsUFA) action date of October 29, 2026, marking the target date for completion of the agency’s review. The development represents an important step toward potential U.S. commercialization of Lucamzi and strengthens Xbrane’s position in the rapidly growing global biosimilars market. If approved, Lucamzi could provide physicians and patients with an additional high-quality treatment option for serious retinal diseases while contributing to improved access and affordability within ophthalmology care.
FDA Acceptance Marks Major Regulatory Milestone
The FDA’s acceptance of the resubmitted application follows Xbrane’s successful response to issues outlined in the Complete Response Letter (CRL) received in October 2025. The company submitted the updated BLA in April 2026 after addressing the agency’s requests and providing additional supporting information. The newly assigned October 29, 2026 BsUFA date now establishes a clear regulatory pathway toward a potential U.S. market authorization. Regulatory acceptance is a critical milestone in the biosimilar approval process, signaling that the application is sufficiently complete for substantive review.
For Xbrane, the development reflects years of investment in biosimilar development, manufacturing optimization, and regulatory preparation aimed at bringing a lower-cost biologic alternative to one of ophthalmology’s most widely used therapies. The FDA review process will now focus on confirming biosimilarity, manufacturing quality, safety, efficacy, and overall comparability to the reference product.
Expanding Access to Ophthalmology Biosimilars
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Lucamzi is being developed as a biosimilar to LUCENTIS® (ranibizumab), a leading anti-VEGF biologic therapy widely used in the treatment of retinal disorders, including neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), and other vision-threatening retinal conditions. These diseases affect millions of patients worldwide and represent a significant burden on healthcare systems due to the need for long-term treatment and regular intravitreal injections. Xbrane’s biosimilar candidate has already demonstrated commercial success in Europe under the brand name Ximluci®, which received market authorization and was launched in 2023.
The European experience provides important validation of the product’s clinical and regulatory profile while supporting confidence in its potential expansion into the United States. The availability of additional biosimilars in ophthalmology is expected to increase competition, improve treatment accessibility, and support broader patient access to biologic therapies that help preserve vision and quality of life.
Strengthening Xbrane’s Biosimilar Growth Strategy
The Lucamzi regulatory milestone aligns with Xbrane’s broader strategy of developing high-quality biosimilars using its proprietary biologics manufacturing platform. The company has built a portfolio targeting reference products with an estimated combined annual peak sales value of approximately EUR 23 billion, highlighting the significant commercial opportunity within the biosimilars sector. By leveraging innovative production technologies designed to reduce manufacturing costs, Xbrane aims to accelerate the availability of affordable biologic medicines while maintaining rigorous quality standards.
A successful FDA approval would represent a transformative event for the company, opening access to the world’s largest pharmaceutical market and reinforcing its position as an emerging leader in biosimilar innovation. As healthcare systems increasingly prioritize cost-effective biologic alternatives, the regulatory progress of Lucamzi underscores the growing importance of biosimilars in expanding patient access to advanced therapies and supporting sustainable healthcare delivery worldwide.
Source: Xbrane Biopharma press release
