
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
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
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
“Our regulatory environment is making it too difficult and expensive for biosimilars to make it to the market,” Lee
Lee’s bill follows a
Of the 39 approved biosimilars in the United States, only 3 of them have been granted interchangeability. Semglee, an insulin glargine biosimilar, was
“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,
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