For those who have a feeling of déjà vu (“all over again”, per Yogi Berra), the recently reintroduced Biosimilar Red Tape Elimination Act into the Senate is yet another attempt to improve the interchangeability conversation. That is, to take the term out of the conversation altogether.
Senate Bill 1954 was introduced June 4 by Senator Mike Lee (R-UT) and is cosponsored by Senators Ben Ray Luján (D-NM), Rand Paul (R-KY), and Margaret Wood Hassan (D-NH). It was referred to the Committee on Health, Education, Labor, and Pensions. If it sounds familiar, it should. The bill, under the same name, was introduced by Senator Lee in the 117th, 118th, and now the 119th Congress, where it found fewer than 6 cosponsors and failed to make it out of committee. We reported on its previous reintroduction in July 2023.
The key provision would be to not remove the term “interchangeability” but to make any approved biosimilar interchangeable with its reference biologic. Either way, it obviates the controversies related to interchangeability designations: the relative quality of biosimilar products, the need for additional clinical switching studies, the weird questions about interchangeability exclusivity, and the secondary questions about delivery device interchangeability. Overall, it retains the principal reason for the designation’s existence: the ability of a pharmacy to automatically substitute a biosimilar for the reference product at the point of dispensing.
The Association for Accessible Medicines is firmly behind the effort by Senator Lee. In a press release, the President and CEO John Murphy stated, “As the FDA has made clear, there is no clinically meaningful difference between biosimilars and interchangeable biosimilars. Yet the US remains the only country in the world with this additional, unnecessary designation—one that brand-name drug companies have exploited to delay or block access to lower-cost biosimilar treatments.”
Will the bill progress towards enactment in this Congress? I’ll be rooting for it, of course, but I can’t think of compelling reasons why this year will be any different. Still, I applaud Senator Lee for his dogged determination.
(Ed. Note: The bill now has the backing of 39 professional societies, payer organizations, and healthcare coalitions. According to a press release on July 8 from the Association for Accessible Medicines, a letter in support of the bill was sent to members of the Senate Health Committee and the US House Committee and Energy and Commerce.)
