11:21 AM
May 10, 2019
 |  BC Extra  |  Politics & Policy

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

Editor's Note: This article was updated on May 10, 2019 at 2:20 PM PDT

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 analytic and clinical tests represents a major portion of biosimilar or interchangeable product development costs, and biologics are often much less expensive outside the U.S.

Boehringer Ingelheim GmbH (Ingelheim, Germany) is the sole company that has started a clinical trial for a biosimilar interchangeability designation. The company has set its sights on an interchangeable biosimilar version of Humira adalimumab from AbbVie Inc. (NYSE:ABBV).

The final guidance retains...

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