An Attempt to Eliminate the Interchangeability Designation

A new senate proposal seeks to remove the Food and Drug Administration’s (FDA’s) interchangeable designation. If passed, it would enable all biosimilars to be considered interchangeable with their individual reference products.

The Biosimilar Red Tape Elimination Act was introduced July 13, 2023 by Senators Mike Lee (R-UT), Ben Ray Lujan (D-NM), Mike Braun (R-IN), and J.D. Vance (R-OH) to further increase competition within the biologics market.

Senator Mike Lee
Senator Mike Lee (R-UT)

The US remains the only major market where any approved biosimilar cannot be freely interchanged for its reference product. This key issue directly affects access to biosimilar agents and potentially to their utilization. The former is related to the cost of performing switching studies that may be required by the FDA to gain the designation. The latter is related to the fact that interchangeability is no guarantee of coverage by the payers, perhaps the most important factor in actual utilization of biosimilars.

In the past, we have published posts on the “value” of interchangeability, both from the perspective of the biosimilar manufacturer and the health system. The cost of conducting multiple switch trials (and the time needed to conduct them) adds tens of millions of dollars to the cost of commercialization for drug makers. Manufacturers have often taken the approach that they would seek conventional biosimilar approval first, and then seek to obtain interchangeability (e.g., Boehringer Ingelheim, Samsung Bioepis/Organon, Amgen, and Pfizer have all taken this approach with their adalimumab biosimilars). Interchangeability has any value only if the reference product retains significant market share over time, because the specific biosimilar can only be interchanged with that reference biologic.

In fact, the term was only included in the biosimilar-enabling BPCIA to permit automatic pharmacy substitution of the reference product with the specific biosimilar. It was never intended to differentiate two biosimilar products based on quality.

All Biosimilars Shall Be Deemed Interchangeable

The Biosimilar Red Tape Elimination Act would amend the federal code to state that “all biosimilars, upon approval, shall be deemed interchangeable.” Instead of voiding the term “interchangeable” altogether, the Act would retain it to minimize disruption of individual states’ existing pharmacy regulations.

The real-world data on the safety and efficacy of biosimilars firmly support the move to eliminate the interchangeability designation. Experts have argued that these multiple switching studies are of very limited or no scientific value.

This bill may not address the question of biosimilar–biosimilar interchangeability, even though the scientific evidence has persuaded the European Medicines Agency to declare that switching among biosimilars is acceptable.

Sarfaraz Niazi, PhD, an industry veteran and scientist who consulted on the bill, stated that it will remove the perception that biosimilars are of two classes of quality and will thus help resolve the educational issue that exists around the quality of biosimilars.

This bill is an update to Senate Bill 6, submitted in November 2022 during the 117th Congress by Senator Lee, which sought to amend language associated with interchangeability. The current proposal seems a more aggressive attempt to remove the existing interchangeability provision. It has at least a measure of bipartisan support in its introduction, and plenty of time in this term for its progression through committee.

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