Xbrane Resubmits Ranibizumab Biosimilar Application to FDA Following Manufacturing Site Corrections
核心洞察
Xbrane Biopharma has resubmitted its Biologics License Application (BLA) to the FDA for its ranibizumab biosimilar candidate following completion of corrective actions at a manufacturing facility.
The resubmission comes after the company received a Complete Response Letter in October 2025 regarding outstanding observations at one of the production sites, which have now been resolved.
The FDA review process for the resubmitted application is expected to take approximately six months, with the biosimilar targeting cost-effective treatment for retinal diseases.
Xbrane Biopharma AB has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration for its biosimilar candidate to LUCENTIS (ranibizumab), following the completion of required corrective actions at a manufacturing facility. The Swedish biotechnology company originally submitted the application in April 2023 but received a Complete Response Letter (CRL) in October 2025 regarding outstanding observations at one of the production sites.
Manufacturing Site Issues Resolved
The FDA's Complete Response Letter specifically addressed remaining observations at one of Xbrane's contract manufacturing facilities. According to the company, no other parts of the BLA application were questioned by the regulatory authority. The outstanding corrective actions have now been finalized and verified at the site concerned, enabling the resubmission.
The manufacturing issues were related to observations concerning a second product that was inspected at the contract manufacturer simultaneously with Ximluci, Xbrane's ranibizumab biosimilar. The company had initially planned an earlier resubmission but experienced a minor delay as the contract manufacturer needed to address all FDA feedback before proceeding.
Regulatory Timeline and Review Process
Following the resubmission, Xbrane expects the FDA review process to take approximately six months. The company had previously indicated plans to resubmit during April/May 2026, after receiving detailed feedback from the FDA regarding the CRL requirements.
Martin Åmark, CEO of Xbrane, and the company continue to drive the candidate toward approval in the United States. The goal is to offer a more cost-effective treatment option for patients with age-related macular degeneration (搜索), retinal vein occlusion (搜索), and myopic choroidal neovascularization (搜索).
Established European Market Presence
Xbrane's ranibizumab biosimilar has already achieved regulatory success in other markets. The European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) approved the biosimilar in November 2022. The product, marketed as Ximluci, has been used commercially in relevant European regions since March 2023.
Company Platform and Portfolio
Xbrane Biopharma develops biological drugs based on a patented platform technology that the company claims provides significantly lower production costs compared to competing systems. The company maintains a portfolio of biosimilar candidates targeting EUR 23 billion in estimated annual peak sales of the respective reference products.
The Stockholm-based company, listed on Nasdaq Stockholm under the ticker XBRANE, positions Ximluci as its lead candidate. With headquarters in Solna, just outside Stockholm, Xbrane continues to focus on bringing cost-effective biosimilar treatments to global markets.