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Category Archives: Pharmaceuticals

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The End of “Pay For Delay”?

More brand-name drug companies have been paying their competitors to delay their efforts to bring generic versions of blockbuster pharmaceuticals to market. The Federal Trade Commission estimates there were 28 “reverse payment” agreements in 2011—twice the number in 2007—involving 25 different branded pharmaceuticals with annual U.S. sales of more than $9 billion. A string of… Continue Reading

Biosimilars: On a Different Path

Brand-new FDA guidelines have created a long-awaited shortcut for bringing biosimilars—cheaper versions of biologically derived pharmaceuticals—to the U.S. market. But the pathway won’t be nearly as straightforward as the one for generic versions of less complex, chemically based drugs that was created under the Hatch-Waxman Act in 1984. Unlike the Hatch-Waxman route, the biosimilar guidelines… Continue Reading