Ophthalmic Bevacizumab Reaches Critical Review Stage In EU
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.
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Chinese firms Shanghai Henlius Biotech and Essex Bio-Technology have announced a key milestone in their Chinese Phase I clinical study for the HLX04-O biosimilar bevacizumab candidate to treat wet age-related macular degeneration.
Using the cancer drug off-label to treat wet AMD has been controversial.
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.