Xbrane Biopharma
Xbrane provides regulatory update on FDA review of its ranibizumab biosimilar candidate
Xbrane Biopharma AB (“Xbrane”), a leading Swedish biosimilar developer, announce that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the Company’s Biologics License Application (BLA) for its ranibizumab biosimilar candidate (development name Xlucane) for treatment of retinal disorders.
Xbrane will work closely with the agency to submit as quickly as possible responses to the issues raised, which relate primarily to the reference standard and pre-approval inspections of manufacturing partners’ sites.
On the reference standard that will be used for release of the product for the US market, FDA requested a tighter specification on one analytical method. Xbrane is confident of being able to resolve this issue.
Regarding FDA observations following pre-approval inspections, Xbrane will continue to work closely with its partners to implement the proposed improvements provided in the responses to the inspections performed by FDA. To date, FDA has not requested re-inspections of any sites.
To further clarify, FDA has not requested any additional clinical trials nor any further studies to demonstrate biosimilarity.
Xbrane will request a meeting with FDA, expected to be held within 30 days from request, to clarify further requirements related to above issues and will after that announce a planned date for resubmission of the BLA.
By reason of the news, Xbrane invites to a webcast Monday April 22nd, at 14.00 CET
If you wish to participate via audiocast please use the link below. Via the audiocast you are able to ask written questions.
https://ir.financialhearings.com/xbrane-biopharma-press-conference-april-2024
If you wish to participate via teleconference please register on the link below. After registration you will be provided phone numbers and a conference ID to access the conference.
https://conference.financialhearings.com/teleconference/?id=5006147
| Datum | 2024-04-21, kl 17:30 |
| Källa | MFN |
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