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Interchangeable Biosimilars: FDA Clarifies US Reference Not Mandatory For Studies

 
• By Derrick Gingery

Draft guidance strongly recommends against it, but US FDA's Leah Christl says agency is willing to talk about using foreign-licensed comparators.

Twin girls are exercising on a lake shore, sprinkling water.

The US FDA may not strictly adhere to the hardline stance against using foreign-licensed reference products in interchangeability studies conveyed in its draft guidance. The door apparently is open to applications that rely on non-US products, even though the agency does not recommend it.

Leah Christl, associate director for therapeutic biologics in FDA's Office of New Drugs, tried to make clear Oct. 25 during the Drug Information Association's Biosimilars Conference that the agency's strong...

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