Xbrane Biopharma announced today that the U.S. Food and Drug Administration (FDA) has established October 21, 2025, as the Biosimilar User Fee Act (BsUFA) decision date for the company's ranibizumab biosimilar candidate. This development follows Xbrane's resubmission of its Biologics License Application (BLA) to the FDA in December 2024.
The regulatory review process officially commenced after Xbrane submitted additional documentation from its manufacturing facilities. Final approval remains contingent on successful re-inspections of these manufacturing sites, which have already addressed observations from FDA inspections conducted earlier in 2024.
Manufacturing Site Remediation
Both manufacturing facilities involved in the production of Xbrane's ranibizumab biosimilar have completed remediation efforts to address FDA observations identified during inspections in 2024. The company has confirmed that all relevant documentation regarding these corrective actions has been submitted to the FDA for review.
The resubmission represents a critical step forward for Xbrane after addressing manufacturing concerns that had previously delayed the approval process. Industry analysts note that manufacturing compliance is often a significant hurdle in biosimilar approvals, particularly for complex biologics like monoclonal antibodies.
Addressing Unmet Patient Needs
Ranibizumab is an anti-vascular endothelial growth factor (anti-VEGF) therapy administered via intravitreal injection. The reference product, Lucentis®, developed by Genentech (a member of the Roche Group), is approved for several ophthalmic conditions.
Xbrane has emphasized its commitment to advancing this biosimilar candidate toward U.S. approval as quickly as possible. The company aims to provide a more affordable treatment alternative for patients suffering from several serious eye conditions, including:
- Age-related macular degeneration (AMD)
- Retinal vein occlusion (RVO)
- Myopic choroidal neovascularization (mCNV)
These conditions represent significant causes of vision impairment and blindness worldwide. AMD alone affects approximately 11 million people in the United States and is the leading cause of vision loss among people over 50 years of age.
Market Impact and Cost Considerations
If approved, Xbrane's ranibizumab biosimilar would enter a competitive market for ophthalmic anti-VEGF therapies. Lucentis® has been a blockbuster drug for Genentech, with global sales exceeding $3.5 billion annually at its peak.
The introduction of a biosimilar alternative could significantly reduce treatment costs for patients and healthcare systems. Biosimilars typically enter the market at prices 15-30% lower than their reference products, potentially expanding access to these sight-saving treatments.
Dr. Martin Åmark, CEO of Xbrane Biopharma, stated in a previous communication: "We remain confident in the quality and similarity of our ranibizumab biosimilar candidate. Our focus is on working closely with the FDA to bring this important treatment option to patients in the United States."
Regulatory Context
The FDA's biosimilar approval pathway requires demonstration that the biosimilar is highly similar to the reference product with no clinically meaningful differences in terms of safety, purity, and potency. The review process includes rigorous analytical, non-clinical, and clinical evaluations.
The October 2025 BsUFA date represents the target action date by which the FDA aims to complete its review of Xbrane's application. This timeline aligns with the standard review period for biosimilar applications following resubmission.
Xbrane's ranibizumab biosimilar has already received marketing authorization in the European Union, where it is marketed under the brand name Ximluci®. The European approval provides some confidence regarding the product's prospects in the U.S. market, though FDA requirements may differ in certain aspects.
As the review process continues, Xbrane will likely focus on ensuring manufacturing readiness and preparing for potential commercial launch in late 2025, pending FDA approval.
