The CRL refers to observations following a re-inspection of one of Xbrane’s contract manufacturers.

“We are very disappointed about the FDA’s decision to issue a CRL to our BLA. We believe US patients and payors would significantly benefit from a more cost-efficient alternative to existing approved treatments against retinal disorders and we are committed to work swiftly towards a re-submission of the BLA,” says Xbrane’s CEO Martin Åmark.

Xbrane re-submitted its BLA in December 2024 following a CRL received in April 2024 due to observations following inspections at its contract manufacturers production sites.

Xbrane has during the weekend received a CRL from FDA stating unresolved observations following the inspection at one of the production sites without further specification.

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. Xbrane has 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.

Awaiting further communication from FDA

Xbrane and its contract manufacturer are now awaiting further communication from FDA, typically received by the production site within few days of issuing the CRL, to better understand the approvability hurdles. Xbrane will work together with the production site to resolve the issues mentioned, and to allow a re-submission of the BLA as soon as possible.

Xbrane’s Lucentis biosimilar has been approved by EMA and MHRA since November 2022 and has been benefiting patients in related regions since March 2023. Close to 200,000 vials have been shipped to end-users without any issues.