Brief: Xbrane Provides Regulatory Update On FDA Review
20/10/2025 07:37
Oct 20 (Reuters) - Xbrane Biopharma AB XBRANE.ST: SAID ON SUNDAY FDA ISSUED COMPLETE RESPONSE LETTER (CRL) TO THE COMPANY'S BIOLOGICS LICENSE APPLICATION (BLA) FOR ITS RANIBIZUMAB BIOSIMILAR CANDIDATE FOR TREATMENT OF RETINAL DISORDERS CRL REFERS TO OBSERVATIONS FOLLOWING A RE-INSPECTION OF ONE OF XBRANE’S CONTRACT MANUFACTURERS FDA CONDUCTED RE-INSPECTIONS DURING Q3 2025 OF BOTH PRODUCTION SITES INVOLVED IN PRODUCTION OF DRUG SUBSTANCE AND DRUG PRODUCT RESPECTIVELY THOROUGH EVIDENCE ON CORRECTIVE ACTIONS TO THE RESPECTIVE OBSERVATIONS WAS SUBMITTED BY BOTH PRODUCTION SITES IN DUE TIME TO THE FDA DURING THE WEEKEND RECEIVED A CRL FROM FDA STATING UNRESOLVED OBSERVATIONS FOLLOWING THE INSPECTION AT ONE OF THE PRODUCTION SITES WITHOUT FURTHER SPECIFICATION NO OTHER ISSUES RELATED TO THE BLA WERE MENTIONED BY THE FDA IN THE CRL XBRANE AND ITS CONTRACT MANUFACTURER ARE NOW AWAITING FURTHER COMMUNICATION FROM FDA Source text for Workspace: nMFN8vrmCQ Further company coverage: XBRANE.ST (Gdansk Newsroom) ((gdansk.newsroom@thomsonreuters.com; +48 58 769 66 00;))