Senator Reintroduces Biosimilar Red Tape Elimination Act

Senator Mike Lee (R, Utah) reintroduced his bill calling to end costly and time-consuming switching study requirements for companies to obtain interchangeability for biosimilars.

The Red Tape Elimination Act was originally introduced to Congress by Senator Lee in November 2022. The bill was read twice and referred to the Committee on Health, Education, Labor, and Pension. No more actions were taken to further the bill.

The new version of the bill would:

• Amend the federal code to state that all biosimilars, upon approval, shall be deemed interchangeable
• Get rid of the current requirement in code that has been used to justify switching studies
• Require the FDA to conduct a private briefing with relevant committee heads if the agency wants to require a switching study

The bill still uses the term “interchangeable” because every state, as well as the District of Columbia and Puerto Rico, have laws regarding the interchangeability of biosimilars. Retaining the word would allow for minimal disruption to current biosimilar distribution.

“This bill would not affect states’ ability to craft their own laws regarding biosimilar substitution. It would merely send an accurate signal to the states regarding the nature of interchangeability,” Lee wrote in a statement.

Interchangeability designations allow for pharmacists to distribute an interchangeable product in place of a reference product or another biosimilar. The label is intended to expand access to biosimilars and mitigate the impacts of drug shortages and supply chain challenges.

In most cases, excluding insulin and anti–vascular endothelial growth factor products, if a company want its biosimilar products to have an interchangeability label, they must conduct a study where patients are switched back and forth at least 3 times between the reference product and the biosimilar. As of July 2023, there are only 4 biosimilars with the label: 2 insulin glargine products (Rezvoglar and Semglee), 1 ranibizumab product (Cimerli), and 1 adalimumab product (Cyltezo).

Biosimilars can cost companies between $100 million and $300 million, according to an analysis by McKinsey & Company.

The value of an interchangeability is debated because there aren’t many interchangeable biosimilars on the market. However, now that the United States has 8 adalimumab biosimilars on the market, several of which may have interchangeability in the future, the prospect for interchangeability has been a cause for concern because depending on supply chain demand, payer coverage, and individual pharmacy availability and policies, waiting for a physician to approve dispensing for a biosimilar can cause delays in care and effects on quality of life.

“While the future looks promising, major obstacles remain to biosimilars achieving their full cost-saving potential. The FDA’s two-tiered system for approval has confused physicians, patients, and states about biosimilars’ safety and efficacy,” Lee commented.

Additionally, in the small molecule space, generic drugs do not need to prove that switching is safe for pharmacies to exchange them with brand drugs without physician permission, leading many biosimilar advocates to wonder if biologic drugs should be treated similarly.

In April 2023, the American Society of Clinical Oncology published a policy statement in favor of abolishing the distinction between approved biosimilars and interchangeable biosimilars.

“The [Biologics Price Competition and Innovation Act] distinction between interchangeability designation and biosimilars is unnecessary, burdensome, and creates barriers to high value care.”