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Senator Introduces Bill to Rid Switching Study Requirements for Interchangeability


The Biosimilar Red Tape Elimination Act will seek to increase patient access to biosimilars by reducing switching study requirements for companies to obtain interchangeability designations.

A new bill dubbed the Biosimilar Red Tape Elimination Act was introduced to the Senate. The bill seeks to increase patient access to biosimilars by reducing switching study requirements for getting interchangeability designations, making it easier and cheaper for corporations to establish interchangeability and patients to obtain their biologic medications.

“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,” wrote Senator Mike Lee, R-Utah, the bill’s sponsor, in a statement.

For most biosimilars, if a company wants to obtain an interchangeability designation, which allows pharmacists to substitute reference products with biosimilars without requiring physician permission, it must conduct costly and timely switching studies. These studies are in addition to the clinical safety and efficacy data that are submitted for general FDA approval.

Currently, there are 4 biosimilars with interchangeable designations (Semglee, Rezvoglar, Cimerli, Cyltezo). Because of the long clinical history of insulin products and the administration method of ranibizumab products, respectively, the FDA granted Semglee, Rezvoglar (insulin glargine biosimilars), and Cimerli (ranibizumab biosimilar) interchangeability designations without requiring switching studies. Cyltezo is the only biosimilar requiring data from switching studies for interchangeability that has completed data collection and gone through the FDA interchangeability review process.

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, as the United States gets closer to the 2023 introduction of at least 7 adalimumab biosimilars, 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.

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.

“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. 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. The amendments suggested in the bill are based on scientific and ethical considerations, and it must be voted in by the Senate,” said Sarfaraz K. Niazi, PhD, a professor, biosimilar advocate, and a member of The Center for Biosimilars® Advisory Board.

Another argument against switching studies is that the United States is the only global market that requires them and has interchangeability designations. In the European Union, biosimilars are regularly substituted for other biosimilar and the reference products. In fact, in September 2022, the European Medicines Agency declared that all biosimilar medicines are interchangeable with other biosimilars and their reference products. The United Kingdom’s Medicines and Healthcare Products Regulatory Agency shortly followed suit in November 2022.

Making interchangeable designations easier to obtain for biosimilars could decrease research and development costs for companies, which could also prevent some biosimilars from being priced higher than other biosimilars and increase access to lower-cost options for patients.

“With healthcare costs continuing to increase, we are grateful for Senator Lee's leadership in helping patients get access to lower-cost biosimilar drugs by eliminating the red tape and unnecessary studies and steps that go into gaining FDA certification. This will be a huge help to our patients as they look to stay out of higher cost care settings through better access to affordable medications,” commented Beau Sorensen, chief operating officer of First Choice Home Health & Hospice in Utah.

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