Xbrane Biopharma

Legal Proceedings Report • Dec 31, 2024

XBRANE RE-SUBMITS BLA FOR RANIBIZUMAB BIOSIMILAR CANDIDATE TO FDA

Xbrane Biopharma AB (publ) ("Xbrane" or "the Company") (Nasdaq Stockholm: XBRANE) has resubmitted the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) to FDA (US Food and Drug Administration).

Xbrane submitted the BLA for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) to the FDA in April 2023 and subsequently received a Complete Response Letter (CRL) in April 2024. In the CRL FDA requested additional information related to the reference standard and follow-up actions from the pre-approval inspections of manufacturing partners' sites. Xbrane has since, after alignment with FDA, qualified a new reference standard and worked together with its manufacturing partners to complete the requested follow-up actions. The review cycle of a resubmitted BLA is typically 6 months.

Xbrane is fully committed to advance its investigational biosimilar candidate towards approval in the United States as quickly as possible to provide a much needed, cost-efficient treatment alternative for patients suffering from Age-related Macular Degeneration (AMD), retinal vein occlusion (RVO) or myopic choroidal neovascularization (mCNV).

LUCENTIS® is a registered trademark of Genentech Inc.

Contacts

Martin Åmark, CEO E: martin.amark@xbrane.com

Anette Lindqvist, CFO/IR E: anette.lindqvist@xbrane.com

About Us

Xbrane Biopharma AB develops biological drugs based on a patented platform technology that provides significantly lower production costs compared to competing systems. Xbrane has a portfolio of biosimilar candidates targeting EUR 26 billion in estimated annual peak sales of the respective reference product. The lead candidate Ximluci® is granted market authorization approval in Europe and was launched during 2023. Xbrane's head office is in Solna, just outside Stockholm. Xbrane is listed on Nasdaq Stockholm under the ticker XBRANE. For more information, visit www.xbrane.com

This information is information that Xbrane Biopharma is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-12-31 09:00 CET.

Attachments

XBRANE RE-SUBMITS BLA FOR RANIBIZUMAB BIOSIMILAR CANDIDATE TO FDA