Ever since the Biologics and Price Competition and Innovation Act (BPCIA) of 2009 found its way into the Affordable Care Act, various stakeholders have been preparing for the U.S. introduction of these so-called “biosimilars.”
Novartis/Sandoz announced in July 2014 that EP2006 was the first 351(k) application accepted for review by US Food and Drug Administration (FDA), an event that occurred almost four and a half years after passage of the BPCIA. And on January 7, 2015 the FDA Oncologic Drugs Advisory Committee (ODAC) recommended approval of Novartis/Sandoz’ investigational biosimilar filgrastim in the US. The Committee also recommended approval of the biosimilar for use in all indications included in the referenced product’s (Amgen’s NEUPOGEN®) label.
