No two classes of biosimilars: Urgent advice to the US Congress and the FDA

What is known and objective The United States is the only country with legislation to approve two classes of biosimilars. One has no clinically meaningful difference from the reference product, and when it is tested for switching and alternating, it can receive an interchangeable status. The objective of this review is to establish whether it is possible from the switching and alternating studies to evaluate additional safety or efficacy. Methods Analysed published data to ascertain if the testing with switching and alternating provide additional proof of safety or efficacy. Political and scientific rationale of creating a new class of biosimilars and how this affects the confidence in biosimilars. Results and discussion There is no safety or efficacy concern when switching or alternating biosimilars with the reference product. Unfortunately, the rationale for interchangeability is more political than scientific, and it has brought more confusion and mistrust in using biosimilars in the United States. What is new and conclusion The US Congress is requested to remove the interchangeability clause from the Biological Price and Competition Act to enable faster acceptance of biosimilars and remove the threat of lack of confidence in the safety of biosimilars.

Automated summary

The United States is the only country with legislation approving two classes of biosimilars. However, the interchangeability standards are more politically driven than scientifically validated, leading to confusion and mistrust in the use of biosimilars in the US.