In his newest column, Sarfaraz K. Niazi, PhD, looks into the domestic and international support for removing interchangeability for biosimilars in the United States.
Only the United States has 2 classes of biosimilars, one that has no clinically meaningful difference with the reference product and the other interchangeable biosimilar that undergo additional extensive testing. Both are tested the same way yet get awarded different statuses, a practice that has greatly damaged the adoption of biosimilars in the US. (Figure 1).
To remove the interchangeability status, Senator Lee has introduced a bill in the Senate that modifies the language in the BPCIA. The passage of this bill will bring the FDA in concordance with the rest of the regulatory agencies, remove misconceptions about biosimilars and expedite the adoption of biosimilars. In addition, biosimilars can also be switched with other biosimilars, and both the European Medicines Agency and the United Kingdom’s Medicines and Healthcare products Regulatory Agency have issued specific clarifications removing all interchangeable designations. No other global regulatory agency offers interchangeability; it is treated like any other drug, where the prescriber decides whether to substitute.
I invite my colleagues and stakeholders to write to me to add to or question the conclusions drawn in this article at firstname.lastname@example.org.
 Niazi SK. No two classes of biosimilars: urgent advice to the US Congress and the FDA. J Clin Pharm Ther. 2022;47(9):1352-1361. doi:10.1111/jcpt.13743
 Biosimilar product information. FDA. Updated December 7, 2022. Accessed December 13, 2022. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
 Biosimilar medicines can be interchanged. EMA. September 19, 2022. Accessed December 13, 2022. https://www.ema.europa.eu/en/news/biosimilar-medicines-can-be-interchanged
 Guidance on the licensing of biosimilar products. United Kingdom’s MHRA. November 7, 2022. Accessed December 13, 2022. https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products