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BioRationality: US Senate Reignites the Push for Biosimilars to Become Interchangeable


Sarfaraz K. Niazi, PhD, details his efforts to encourage congressional leaders to draft legislation that would remove interchangeability requirements and animal toxicology studies for biosimilars.

On July 14, Senator Michael Lee of Utah reintroduced his earlier bill titled the Biosimilar Red Tape Elimination Act, a follow-up to his earlier submission to remove the class of biosimilars labeled as “interchangeable biosimilar,” a classification granted upon additional switching and alternating studies with the reference product after a product had been declared as a biosimilar.

The FDA had recently exercised its decision-making to allow interchangeable status to 1 product, a ranibizumab biosimilar (Cimerli), without switching and alternating studies. The updated bill is a bipartisan bill with Senator Ben Ray Luján (D, New Mexico) joining 3 republican senators. It is noteworthy that Senator Lujan was also the first to suggest that the animal toxicology study of biosimilars should be eliminated; it was when he joined hands with other senators as The FDA Modernization Act 2.0 did.

The current Red Tape Elimination Act will render all biosimilars interchangeable unless any issues must be discussed at the committee level. It is noteworthy that both the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (the United Kingdom’s equivalent of the FDA and EMA) allow interchangeability with the reference product and other biosimilars. The last part was what I had recommended to the Senator Lee team, as their advisor, to add. However, this additional language, “...and its other biosimilars,” was planned for later addition.

In supporting Senator Lee’s office, I published an intensive analysis of this issue in 2 journal articles, one to show that clinical efficacy testing of biosimilars in patients is of little value,“Scientific Rationale for Waiting Clinical Efficacy Testing, and a detailed analysis why the switching and alternating studies have no scientific rationale, as “No Two Classes of Biosimilars,”

These articles were highlighted in the press release from Senator Lee’s office. After much discussion, I realized that it is not just the science that prevails; it is as much politics. My statement quoted in the press release emphasizes that when the FDA has approved a product, it comes with an assurance that there is no “clinically meaningful” difference with its reference product. It is challenging enough to prove that a biosimilar is not different in any size clinical trial, let alone prove it again, having confirmed that there is no difference. Simple statistical modeling will show that this is not practical. I emphasized and demonstrated with convincing calculations to the senators. A simple demonstration to readers goes as follows: can you tell the difference between the same lot of a product divided into 2 groups of patients in a clinical efficacy test? The answer is yes if the testing population is infinite.

I am happy that despite much opposition, Senators Lee, Luján, as well as Mike Braun (R, Indiana) and J.D. Vance (R, Ohio) have joined hands in pushing for the approval of this bill. I am now writing to every senator and representative about the scientific demerits of such testing and to suggest that such testing is tantamount to patient abuse. I hope they will listen and vote unanimously, as they did in approving The FDA Modernization Act 2.0, which removed animal toxicology testing. Another vigil started with publishing a paper in Science magazine and distributing it to all Senators and Representatives. It worked then, and I am confident it will work again.

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