Pharma pattern

As the US’ Biologics Price Competition and Innovation Act turns 10, Irena Royzman and Christine Willgoos provide a rundown of trends emerging in biosimilar litigation

Irena Royzman and Christine Willgoos - Kramer Levin

In the US, the biosimilar statute turned 10 this year and a number of trends have emerged. The litigations under the Biologics Price Competition and Innovation Act (BPCIA) so far have involved nine blockbuster biologic medicines, antibodies and recombinant proteins. For seven of them, biosimilar products are launched. All district court decisions on the merits have been affirmed and most of the litigations have settled.