180 days post-licensure notice before commercial marketing for all Biosimilar Products is mandatory

Introduction The Present case relates to biologic product Amgen’s pegfilgrastim and legal action under Biologics Price Competition and Innovation Act of 2009 (Biologics Act or BPCIA) (BPCIA or Bio-similars Act, which was enacted on March 23, 2010, as a component of the Patient Protection and Affordable Care Act) The Bio-similars Act was designed to create an abbreviated approval pathway for producers of […]