US biosimilars consensus thwarted by three big issues
This article was originally published in Scrip
Executive Summary
If US FDA officials had hoped a consensus would emerge when they invited all stakeholders to participate in a two-day meeting 2 and 3 November on how to create a pathway for follow-on biologics to get onto the US market, they were surely disappointed. What the FDA did get, however, was a clear indication from speakers from all sides of pharma, from patient advocate groups, from providers groups and from academia what the major issues the agency must try to finesse in putting into effect the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) Congress passed last year. The statute gives FDA a great amount of freedom in interpreting its provisions.