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Senate Bill Would Forbid Switching Studies to Gain Interchangeability Status


A bill introduced by Senator Mike Lee, R-Utah, would prohibit the FDA requiring switching studies for biosimilars to gain interchangeability status.

A new bill would remove the requirement for switching studies to designate a biosimilar as being interchangeable with a biologic, which would put the United States more in line with the European Union. The new bill is aiming to increase competition within the biological drug market and reduce consumer costs by eliminating barriers to access for biosimilars.

Senator Mike Lee, R-Utah, introduced the Biosimilar Red Tape Elimination Act, which would prohibit FDA requiring switching studies in order for biosimilars to receive an interchangeable designation.

Switching studies can cost millions of dollars and are not required in the European Union, which does not have an interchangeable status designation. The European Medicines Agency recently issued a joint statement with the Heads of the Medicines Agencies confirming that all biosimilars approved in the European Union are automatically interchangeable with both the reference product and other, equivalent biosimilars.

The goal of Lee’s bill is to remove a barrier to increasing access to biosimilars, which cost less and can save payers and patients billions of dollars over 5 years. Researchers from RAND Corporation and the Office of the Assistant Secretary for Planning and Evaluation in HHS published research in The American Journal of Managed Care® that projected savings of $38.4 billion from biosimilars between 2021 and 2025. Under “an alternate upper-bound scenario assuming quicker biosimilar entry, greater biosimilar volume share, and more robust price competition,” the savings increase dramatically to $124.2 billion over the same time period.

“Our regulatory environment is making it too difficult and expensive for biosimilars to make it to the market,” Lee said in a statement. “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.”

Lee’s bill follows a bill introduced in the House by 2 Republicans and 2 Democrats, which directs HHS to undertake a study to understand how substitution of interchangeable biologic products may be impeded. The House bill directs the secretary of HHS within 1 year if the bill is passed into law to complete a study evaluating how substitution of interchangeable biologic products may be impeded.

Of the 39 approved biosimilars in the United States, only 3 of them have been granted interchangeability. Semglee, an insulin glargine biosimilar, was the first biosimilar to be granted interchangeability in the United States in July 2021. The other 2 biosimilars with interchangeability are Cyltezo, an adalimumab biosimilar that is anticipated to launch in July 2023, and Cimerli, a ranibizumab biosimilar that launched October 2022.

“According to the FDA, ‘biosimilars have no clinically meaningful difference with their reference product,’ so if there is no difference, they should be interchangeable without the extensive and expensive switching and alternating studies in patients,” Sarfaraz K. Niazi, PhD, an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, said. “First, such studies can never fail, as statistics teaches us and as the hundreds of such studies reveal. These studies are tantamount to human abuse. Creating 2 classes of biosimilars has weakened the trust in biosimilars.”

In a presentation at Asembia’s Specialty Pharmacy Summit, Sonia Oskouei, PharmD, vice president, biosimilars, Cardinal Health, discussed the confusion around interchangeability in the United States. While interchangeability simply allows pharmacists to fill prescriptions for biologics with an FDA-approved biosimilar, a common misperception of interchangeable products is that they are superior to other biosimilars that have not gotten the designation. In reality, interchangeability is simply granted by going through an extra step.

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