The law that opened up the approval pathway for biosimilars, known as the Biologics Price Competition and Innovation Act (BPCIA), turned 10 years old this week and nearly 100 drugs officially became biologics under what’s known as the “deemed to be a license” provision of the BPCIA. As anticipated, the shift for these nearly 100 products will mean insulin and treatments for respiratory distress syndrome, fertility conditions, Cushing’s syndrome, deep vein thrombosis, Gaucher disease and others will be marketed under biologics license applications (BLAs) and see biosimilar competition moving forward. Earlier this month, the FDA finalized guidance on what this transition means for sponsors of these products. Learn More