UK Court Ruling Ends Novartis/Bayer Crusade Against Avastin In AMD
Off-Label Use Does Not Undermine Licensing System
AMD patients in the UK can legitimately be given compounded bevacizumab (Roche’s Avastin) after the appeals court said NHS trusts could offer a drug off-label for economic reasons where there were no safety or efficacy concerns.
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Sponsors of several new medicines, including the first ever CAR-T for multiple myeloma, will find out this week if their products are on track to get EU marketing authorizations. Also, three sponsors might be asked to address outstanding issues about their products in the final stages of review.
The sponsor of what could become the EU’s first approved ophthalmic formulation of bevacizumab needs to address outstanding issues raised by the European Medicines Agency about its filing.
An advanced immunotherapy for recurrent glioblastoma and the first biosimilar version of Lucentis for age-related macular degeneration have also been submitted for review by the European Medicines Agency for potential pan-EU authorization.