On November 17, 2022, Sen. Mike Lee (R-UT) introduced a Bill entitled the “Biosimilar Red Tape Elimination Act” with the intent to increase competition within the US biosimilar market and reduce consumer costs associated their development.  The Bill proposes to eliminate the interchangeability requirement of conducting switching studies associated with biosimilar drug development. In September 2022, the European Medicines Agency (EMA) affirmed its position on this topic stating that “systematic switching studies are not required to support the interchangeability at the prescriber level.”


The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) provided for a regulatory pathway under section 351(k) to allow for the approval of biologic products that are shown to be biosimilar to, or interchangeable with, FDA approved biologic products (reference products).  In doing so, the Agency established what some refer to as a ‘two-tiered system’ of approval: those that must demonstrate biosimilarity and those that must demonstrate interchangeability. Typically, an applicant can submit a biosimilar application to gain BLA approval, then supplement that approved application to demonstrate interchangeability.  In determining interchangeability, there are a host of factors that require additional consideration (see guidance here).  However, in most cases involving a biologic that is intended for multiple-dose administration, interchangeability is demonstrated by conducting a “switching study” which is designed to switch the clinical study population from the biosimilar study drug to the biological reference drug to demonstrate no greater risk to efficacy or safety in the biosimilar study group.

The Bill

The proposed bill is intended to remove the requirement for interchangeability switching studies based on the argument that a biosimilar, when approved, has demonstrated there is “no clinically meaningful difference to the referenced biologic”.  While additional arguments can be made that these interchangeability studies provide another layer of safety, there are many that argue that it creates confusion and additional development costs. In addition, many refer to EMA’s recent position on this issue that was based on 10 years’ worth of retrospective market review of biosimilar safety data in the European Union.

The Brass Ring

There are many advantages in obtaining an “interchangeable status” for a biosimilar, with the most notable being the ability to have pharmacies substitute their biosimilar product for the brand biologic with no approval from the health care provider. Of course, the ability to substitute varies by state, with most states allowing substitution if the cost is lower to the patient and the brand prescription is not specified by the health care provider.

Market Impact

The biosimilar market is booming, and estimates claim health care savings of over $180 billion over the next five (5) years with the introduction of biosimilars.  Given this financial impact, it is clear why numerous efforts are underway to streamline the approval process and lower the costs associated with biosimilar drug development.

Senator Lee‘s Bill is not the first action to address this. Under BsUFA III, FDA has established performance goals and procedures to streamline this process and continually reassess biosimilar drug development throughout the fiscal years of 2023-2027.


It’s a wait-and-see moment that will likely spark further debate weighing biosimilar development costs against the continued need for interchangeability studies and may be bolstered by retrospective data from actual clinical use.