US drug, biologics chiefs give peek into biosimilar planning efforts
This article was originally published in Scrip
Executive Summary
As drug makers anticipate the release of biosimilar guidelines from the US FDA by the end of this year, regulators in a 3 August article in the New England Journal of Medicine (NEJM) gave a peek into some of their expectations for the new approval pathway – an authority the agency gained in last year's health reform bill.