On November 17, 2022, Senator Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase biosimilar competition and reduce patient costs by prohibiting the FDA from requiring switching studies to approve a biosimilar as interchangeable.

Unlike other countries, the U.S. currently has two designations for biosimilar drugs: biosimilar and interchangeable.  Under the Biologics Price Competition and Innovation Act (BPCIA), for a biosimilar to be approved as interchangeable, the FDA requires additional information beyond that needed to prove biosimilarity, which usually includes a switching study.  These costly studies involve switching a patient between a biosimilar and a reference product to show there is no increased risk or diminished efficacy compared to using only the reference product.

The benefit of an interchangeable designation, and tradeoff for conducting the additional studies, is that interchangeables, unlike biosimilars, can be automatically substituted for their reference product at the pharmacy, without intervention by the prescribing doctor (subject to state laws), similar to generic small molecule drugs.  There is also the possibility of marketing exclusivity for the first interchangeable of a reference product.  The increased costs of approval however, may impact costs for patients.

Despite 41 biosimilars having been approved in the U.S. to date, the burdens of interchangeability studies have led to only four interchangeable approvals thus far: Semglee® (insulin glargine-yfgn), Cyltezo® (adalimumab-adbm) (see First Interchangeable FDA Approval without a Switching Study), Cimerli™ (ranibizumab-eqrn), and Rezvoglar™ (insulin glargine-aglr).

The Biosimilar Red Tape Elimination Act would bring the U.S. in line with other countries that do not require additional studies to prove interchangeability.  Recently, the European Medicines Agency (EMA), after studying over 10 years of data on biosimilars, found no difference in “nature, severity or frequency of adverse events between biosimilars and their reference medicines” and deems all biosimilars interchangeable with their reference products and other biosimilars of the same reference product (see Biosimilars Approved in the EU are Considered Interchangeable).  The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a revised guidance earlier in November 2022 that outlined the same position on interchangeability as the EMA.

If passed, the legislation could impact prices for patients, bring biosimilars to market more quickly, and may increase patient and physician confidence in biosimilars.

The text of the bill can be read here.



    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website ( Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.


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