Commercial PotentialMOLBREEVI is anticipated to achieve blockbuster status in the US, contingent on its approval.
Product Approval And Market GrowthThe approval of MOLBREEVI, along with the growing availability of a simple diagnostic test, is expected to drive earlier diagnosis and market growth.
Regulatory And Manufacturing StrategyThe decision to proceed with Fujifilm rather than GEMA Biotech, together with substantial data generated from the Process Performance Qualification campaigns at Fujifilm and the FDA’s alignment on both the analytical comparability package and the CMC data to be included in the BLA, meaningfully de-risks the filling process.