Xbrane Files BLA For Ranibizumab Biosimilar Candidate To FDA

Xbrane Biopharma AB (publ) ("Xbrane" or the "Company") has submitted a BLA (Biologics License Application) for its biosimilar candidate for LUCENTIS (ranibizumab) to the FDA (US Food and Drug Administration).

Xbrane submitted the BLA for its investigational biosimilar candidate LUCENTIS (ranibizumab) to the FDA in April 2023 and subsequently received a Complete Response Letter (CRL) in April 2024. In the CRL, the FDA requested additional information related to the reference standard and actions arising from inspections of contract manufacturers’ facilities. Xbrane has since, in consultation with the FDA, qualified a new reference standard and worked with its contract manufacturers to ensure demonstrated actions. The review cycle for a resubmitted BLA is typically 6 months.

Xbrane is fully committed to advancing its biosimilar candidate for investigational approval in the US as quickly as possible to provide a much-needed, cost-effective treatment option for patients suffering from age-related macular degeneration (AMD), retinal vein occlusion (RVO) or myopic choroidal neovascularization (mCNV).

About Xbrane Biopharma AB
Xbrane Biopharma AB develops biologics based on a patented platform technology that provides significantly lower production costs compared to competing systems. Xbrane has a portfolio of biosimilar candidates that together address EUR 26 billion in expected annual peak sales of the respective reference drug. The leading biosimilar candidate Ximluci is approved in Europe and launched in 2023. Xbrane's headquarters are located in Solna, just outside Stockholm. For more information, visit www.xbrane.com.