Charles Lyon, DPhil and Robert Sahr, PhD on FDA Regulation of Antibody Drug Conjugates

View "Inside FDA Regulation of Antibody Drug Conjugates."

Charles Lyon and Robert Sahr wrote “Inside FDA Regulation of Antibody Drug Conjugates” in Intellectual Property Law360, where they discuss the FDA’s recent decision to regulate ADCs as biologics.  They explain that the antibody in an ADC provides the primary mode of action and thus should be regulated as such.  They also discuss the 12-year data package exclusivity period.  The article also appeared in Life Sciences Law360 and Public Policy Law360.