WASHINGTON — The FDA on Friday spelled out exactly what kind of studies biosimilar drug makers must conduct in order to be considered “interchangeable” with a biologic drug the way a generic functions for a normal medicine.
It’s the agency’s final word on a controversial and long-running fight over how it will define those rules for the pricey category of biologic drugs, the complex drugs made from living organisms used to treat conditions like cancer, and their copycat biosimilars.
Biosimilars have been held up by supporters as a market-friendly way to drive down the cost of some of the world’s most expensive drugs. And advocates for the nascent industry have long been calling for Friday’s policy because, they argue, more “interchangeable” drugs — and more certainty in the rules around them — will increase the likelihood that doctors and patients use biosimilars over biologics.
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