21 August 2019 - A major reason drugs are even mildly affordable in the U.S. is that cheap generic copies can eventually flood the market. 

But first the Food and Drug Administration grants new drugs a few years of monopoly “exclusivity.” For decades this high-price-before-low-price model has fuelled astounding pharmaceutical innovation while also providing long-term access to important treatments.

But today this model is in trouble. An entire class of high-priced medicines, called biologics, may never face strong competition from copycats. These drugs—which are used for cancer, rheumatoid arthritis, and other serious illnesses—accounted for 37% of all spending on drugs in 2017 even though they were only 2% of all medicines dispensed. While chemical drugs can be easily mimicked by generic drugs, biologic drugs are made in genetically engineered cells, a process that cannot be perfectly copied.

Read Wall Street Journal article