FDA finalizes guidance on interchangeable biosimilars

|About: AbbVie Inc. (ABBV)|By:, SA News Editor

The FDA has completed its long-anticipated guidance on interchangeability of biosimilars, allowing their substitution for reference biologics without prescribers' sign-off.

None has been approved in the U.S. yet, but Boehringer Ingelheim is working on interchangeability status for its biosimilar to AbbVie's (NYSE:ABBV) Humira (adalimumab). Interchangeable insulin products should coming in the next few years.

A key requirement of the new guidelines is a "switching study" aimed at demonstrating that alternating between the biosimilar and branded product does not impact safety or efficacy.

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