By Peter B. Bach and Mark Trusheim Aug. 21, 2019 6:58 pm ET 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 fueled astounding pharmaceutical innovation while also providing long-term access to important treatments.
We recently proposed that the government regulate the prices of older biologics while allowing the market to set prices for newer and more innovative ones like gene therapies. Scott Gottlieb, the Food and Drug Administration’s recently departed commissioner, disagreed. He tweeted in April that “it’s far too early to throw in the towel on biosimilars.”
The average sales price of the brand biologic Neupogen, which increases white-blood-cell counts in cancer patients, is higher today than when it entered the market in 1991, though it has two competitors. Even the Biosimilars Council says biosimilars will only save around $50 billion over the next decade, about what we believe could be saved each year through price regulation.
Even today there are barely a dozen biosimilars on the U.S. market and no competitors on the horizon for dozens of biologic drugs. The barriers to entry are so high that even the hundreds of millions in sales these uncontested products generate isn’t enough to attract even one competitor.
opinion peterbachmd The same model used for Cars Computers Home Appliances Bill Clinton Speaking Fees Rail Travel Air Travel Space Travel
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