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Xbrane Biopharma Advances Biosimilar Candidate Towards FDA Approval

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Xbrane Biopharma Advances Biosimilar Candidate Towards FDA Approval

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Xbrane Biopharma AB ( (SE:XBRANE) ) has issued an announcement.

Xbrane Biopharma AB has re-submitted its Biologics License Application to the US FDA for its biosimilar candidate to LUCENTIS® (ranibizumab), aimed at treating conditions such as age-related macular degeneration. The FDA has set a decision date for October 2025, contingent on successful re-inspections of manufacturing sites. This move underscores Xbrane’s commitment to providing cost-effective treatment alternatives and could enhance its position in the biosimilar market.

More about Xbrane Biopharma AB

Xbrane Biopharma AB is a biopharmaceutical company that develops biological drugs using a patented platform technology designed to reduce production costs compared to other systems. The company has a portfolio of biosimilar candidates targeting significant market opportunities, with its lead candidate Ximluci® already granted market authorization in Europe. Xbrane is headquartered in Solna, Sweden, and is listed on Nasdaq Stockholm.

Average Trading Volume: 18,368,001

Current Market Cap: SEK383.7M

Find detailed analytics on XBRANE stock on TipRanks’ Stock Analysis page.

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