Senate bill would prohibit switching studies to obtain interchangeability status

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

A new bill would remove the requirement to switch studies to designate a biosimilar as interchangeable with a biologic, bringing the United States closer to the European Union. The new invoice aims to increase competition in the biologic drug market and reduce costs for consumers by removing barriers to accessing biosimilars.

Sen. Mike Lee, R-Utah, introduced the Biosimilar Red Tape Elimination Act, which would prohibit the FDA from requiring switch studies for biosimilars to receive an interchangeable designation.

Changing studies can cost millions of dollars and is not mandatory in the European Union, which does not have an interchangeable status designation. The European Medicines Agency recently issued a joint statement with drug agency officials confirming that all biosimilars approved in the European Union are automatically interchangeable with the reference product and other equivalent biosimilars.

The goal of Lee’s bill is to remove a barrier to improving 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, HHS research published in The American Journal of Managed Care® which predicted savings of $38.4 billion from biosimilars between 2021 and 2025. Under an “alternative upper-bound scenario assuming faster biosimilar entry, higher biosimilar volume share, and competitive more robust pricing,” the savings increase significantly to $124.2 billion over the same period.

“Our regulatory environment makes it too difficult and too expensive for biosimilars to get to market,” Lee said. said in a press release. “Ultimately, it is the patients who suffer from the lack of competition and high drug prices. My bill, the Eliminating Biosimilar Bureaucracy Act, would remove the barriers that prevent consumers from accessing these life-changing medicines.

Lee’s bill follows a bill tabled in the House by 2 Republicans and 2 Democrats, which directs HHS to undertake a study to understand how the substitution of interchangeable biologics may be hindered. The House bill directs the Secretary of HHS within one year if the bill is passed to complete a study evaluating how the substitution of interchangeable biologics can be hindered.

Of the 39 biosimilars approved in the United States, only 3 of them have obtained interchangeability. Semglee, a biosimilar to insulin glargine, has been the first biosimilar to obtain interchangeability in the United States in July 2021. The other 2 biosimilars with interchangeability are Cyltezoan adalimumab biosimilar scheduled for launch in July 2023, and Cimerlia ranibizumab biosimilar launched in October 2022.

“According to the FDA, ‘biosimilars have no clinically significant difference from their reference product’, so if there is no difference, they should be interchangeable without the extensive and costly switching and alternation studies in patients,” said Sarfaraz K. Niazi, PhD, an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston. “First, such studies can never fail, as statistics teach us and as hundreds of such studies reveal. These studies amount to human abuse. The creation of 2 classes of biosimilars has weakened confidence in biosimilars. »

In a presentation at Asembia’s Specialty Pharmacy Summit, Sonia Oskouei, PharmD, Vice President, Biosimilars, Cardinal Health, discussed confusion around interchangeability in the USA. 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 achieved designation. In reality, interchangeability is simply granted by going through an additional step.

Norman D. Briggs