Sen. Lee Introduces Biosimilar Red Tape Elimination Act

Press Release

Sen. Mike Lee (R-UT) introduced the Biosimilar Red Tape Elimination Act to increase competition within the biological drug market and reduce consumer costs.

For small-molecule drugs, pharmacists can substitute generics in lieu of their branded counterparts. Access to generics is essential to increasing competition and bringing down the cost of prescription drugs for patients.

The generic equivalent of a biological drug is known as a biosimilar. Unlike generic drugs, many states will not allow pharmacists to substitute a biosimilar unless the FDA declares it to be "interchangeable." This process is cumbersome and expensive.

Acquiring interchangeable status requires the product to undergo switching studies whereby participants must alternate between the biologic and the biosimilar. These studies can cost millions of dollars and further delay market access. After examining 15 years of data, the European Medicines Agency (EMA) recently stated, that switching studies are unnecessary for biosimilars to obtain interchangeable status.

Sen. Lee's bill would prohibit the FDA from requiring biosimilars to undergo switching studies to receive an "interchangeable" designation. Eliminating this barrier would increase access to lower-cost biosimilars and save payers and consumers billions over the next five years.

Of the bill, Sen. Lee said, "Our regulatory environment is making it too difficult and expensive for biosimilars to make it to the market. Ultimately, it's the patients who suffer from a lack of competition and high drug prices. My bill, the Biosimilar Red Tape Elimination Act, would bring down the barriers preventing consumers from accessing these life-changing drugs."

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