Generic drugs now make up over 90% of U.S. prescriptions but cost only 23% of total drug spending. Their history spans 200 years-from unregulated pills to the Hatch-Waxman Act-and they’ve saved trillions. But shortages and price spikes still threaten access.
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Two congressional bills aim to fix drug and healthcare provider shortages, but both are stuck due to the longest government shutdown in U.S. history. Without funding or clear rules, they may expire before ever becoming law.
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The FDA's Purple Book is the official guide to biosimilars and interchangeable biological products in the U.S. Learn how it works, what the difference is between biosimilar and interchangeable, and how state laws affect substitution.
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