FDA issues guidance to help bring interchangeable biosimilars to market
The FDA has completed its guidance on interchangeability of biosimilars, allowing their substitution for reference biologics without prescribers' sign-off. Similar to how generic drugs are routinely substituted for brand name drugs when they are prescribed for patients. None has been approved in the U.S. yet, but Boehringer Ingelheim is working on interchangeability status for its biosimilar to AbbVie's Humira (adalimumab). Interchangeabl
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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