For First Time, F.D.A. Panel Approves Generic Copy of Costly Biologic Drug

January 8, 2015

(New York Times) – An expert panel unanimously recommended on Wednesday that the Food and Drug Administration approve a cheaper copy of a special drug used in cancer therapy, paving the way for alternatives to an entire class of complex and costly drugs to enter the United States market. Most brand-name drugs eventually lose their patent protection, opening the market to lower-priced generic products. But one class of drugs, known as biologics, which includes some of the most expensive medications in the world, has been insulated from the competition of cheaper copies for years.