Debate Over Introduction of Generic Biologics Heats Up

摘要

A LACK of well defined guideliner for follow-on biologics has rewarded the lucky biotech companies who have gotten a drug to market with an essentially unlimited lifeline on their product The food and Drug Administratin (FDA) is now attempting to answer the call fo patient advocates lobbyists for the generics industry and lawmakers by closing the gap in the regulatory framework for biologics.