Forbes November 3, 2025
The Food and Drug Administration Commissioner Marty Makary announced last week that his agency will expedite the biosimilar approval process by eliminating what he called “unnecessary red tape,” helping to speed lower-cost treatments to market. But in the United States, the greater impediments to patient access to biosimilars have been lengthy patent disputes and reimbursement hurdles.
Makary seeks to replace clinical trial requirements for biosimilar marketing authorization with improved analytical testing in most circumstances. At the same time, the commissioner wants to facilitate pharmacy substitution of biosimilars. In particular, he says that “every biosimilar should be interchangeable” without any “switching studies,” analogous to small molecule generics. This would allow pharmacists to more easily substitute biosimilars for originator biologics. Both the...
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