The FDA today unveiled a plan to accelerate development of biosimilars in hopes of significantly reducing drug costs in the United States.
The agency issued draft guidance that would simplify the study of biosimilars and reduce what officials characterized as time-consuming, costly and unnecessary clinical testing.
The FDA also took a separate action to make it easier for biosimilars to be designated as interchangeable with brand-name biologics, allowing patients and pharmacists to more easily opt for lower-cost therapies.
These actions will eliminate the “sky-high costs and endless red tape”