Almost a year after having its filing for a Lucentis (ranibizumab) biosimilar knocked back by the US Food and Drug Administration, Xbrane Biopharma has resubmitted the biologics license application to the US regulator.
Last May, the Swedish firm announced that it had withdrawn its BLA after receiving feedback from the FDA that “complementary...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Generics Bulletin for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?