FDA considering easing use of foreign references for biosimilars

FDA announced new policies to boost the U.S. market for biosimilars Tuesday, and said it is considering easing rules that make it difficult and expensive for biosimilars manufacturers to use biologics manufactured outside the U.S. as reference products.

“We are actively evaluating how we can make it easier for biosimilar manufacturers to use reference products from outside the U.S., where prices may be cheaper and reference products more accessible,” FDA Commissioner Scott Gottlieb said Tuesday. ...