Federal Circuit Extends Biologic Exclusivity by 180 Days Gives Biosimilars A Choice Whether to Disclose Product Information Required by the BPCIA
The Federal Circuit handed down a decision interpreting the Biologics Price Competition and Innovation Act (BPCIA) in a way that effectively grants branded biologics an additional six months of exclusivity. However, in a win for biosimilar applicants, the Federal Circuit also held that the statutory directive to disclose abbreviated application and manufacturing information to the…