Final interchangeability guidance allows non-U.S.-licensed comparators

FDA has released its final guidance on the interchangeability of biosimilars with one notable change from the draft version: sponsors may now use data from non-U.S.-licensed comparator products to demonstrate interchangeability.

The agency said sponsors should provide adequate data to establish a “bridge” between the non-U.S.-licensed comparator and the U.S.-licensed product.

This could dramatically reduce the cost of developing interchangeables. Purchasing samples of the original biologic for

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