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But denosumab is a first-in-class drug: It's a biologic, which means it will likely be much more expensive than its competitor drugs, some of which are available as cheaper generics. The drug also boasts an extremely convenient dosing regimen -- subcutaneous injection every six months.
We expect to file a Biologic License Application (BLA) shortly thereafter. We expect to file a Biologic License Application (BLA) shortly thereafter. The role of the BRMAC is to make recommendations, which are not binding, to the FDA on the clinical sections of Biologic License Applications (BLAs).