FDA Knows Its Own Strength—and It Includes Concentration
FDA Law Blog: Biosimilars
FEBRUARY 26, 2024
Karst — While the Biologics Price Competition and Innovation Act (“BPCIA”) is inherently distinct from the Hatch-Waxman Act, many of the fundamental concepts FDA adopted as it enacted the Hatch-Waxman Act made their way into FDA’s implementation of the BPCIA. mL) in addition to Original Concentration Humira.”
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