2011 Scrip 100: Biosimilars - US to lag behind Europe for years?
This article was originally published in Scrip
With no formal guidance in place, what can the world expect as the US FDA puts together a regulatory framework for biosimilars? Developers are not waiting for an FOB pathway to take shape, and some have vowed to use the existing BLA route at least in the near future, while others are taking a wait-and-see attitude as they conduct early trials and talk to the FDA. Nancy Faigen reports.