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Xbrane Sets Date For Latest Run At Ranibizumab In US

Awaits Manufacturing Sites Inspection Ahead Of October BsUFA Date

 
• By Dave Wallace

After a series of setbacks for its Lucentis (ranibizumab) biosimilar filing in the US, Xbrane Biopharma now has a fresh action date from the FDA – although any approval will be contingent on a successful agency reinspection of its manufacturing sites.

Xbrane is eyeing FDA approval in October (Shutterstock)
Key Takeaways
  • Xbrane Biopharma has revealed 21 October as the latest FDA action date for its proposed biosimilar to Lucentis (ranibizumab).

Xbrane Biopharma has provided an update on its long-gestating filing for a biosimilar version of Genentech’s Lucentis (ranibizumab) in the...

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