Scotuscast

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides an abbreviated pathway for obtaining Food and Drug Administration (FDA) approval of a drug that is biosimilar to an already licensed biological product. Among other things, BPCIA provisions require applicants for approval of a new biosimilar to provide the manufacturer of the already licensed product with a notice of commercial marketing and certain information about the biosimilar. Failure to comply permits the manufacturer to pursue infringement litigation against the applicant on an accelerated basis. -- Amgen claims to hold patents on methods of manufacturing and using filgrastim--a biologic used to stimulate the production of white blood cells--and markets one such product, Neupogen. Sandoz sought FDA approval to market a biosimilar called Zarxio. When the FDA accepted Sandoz’s application for review, Sandoz notified Amgen that Sandoz intended to market Zarxio upon receipt of FDA approval. Sandoz also indicated that it woul