Updated Biosimilar Red Tape Elimination Act introduced by Senator Lee

Home/Policies & Legislation | Posted 25/08/2023 post-comment0 Post your comment

US Republican Senator for Utah, Mike Lee, has introduced an updated ‘Biosimilar Red Tape Elimination Act.’

Interchangeability V18K30

The bill is intended to increase biosimilar competition and reduce patient costs by prohibiting the US Food and Drug Administration (FDA) from requiring switching studies to approve a biosimilar as interchangeable. However, the November 2022 version [1, 2] of the bill did not pass congress. Now, in July 2023, the updated version has been described as ‘more straightforward and definitive’. It aims to amend the federal code to state that all biosimilars that receive FDA approval are, by definition, interchangeable. This wording is key as it addresses state laws blocking pharmacists from dispensing biosimilars that FDA had not explicitly designated as interchangeable.

Acquiring interchangeable status requires the product to undergo switching studies whereby participants must alternate between the biological and the biosimilar. These studies can cost millions of dollars and further delay market access. 

The European Medicines Agency (EMA), after studying over 10 years of data on biosimilars, found no difference in ‘nature, severity or frequency of adverse events between biosimilars and their reference medicines’ and on 19 September 2022 EMA and the Heads of Medicines Agencies issued a joint statement confirming that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicines or with an equivalent biosimilar (see EMA calls for biosimilar interchangeability across the EU) [3]. The UK’s Medicines and Healthcare products Regulatory Agency issued a revised guidance in November 2022 that outlined the same position on interchangeability as the EMA [4].

Sen. Lee’s office is of the opinion that switching studies are unnecessary for biosimilars to obtain interchangeable status.

Sen. Lee’s bill aims to prohibit FDA from requiring biosimilars to undergo switching studies to receive an ‘interchangeable’ designation. It is hoped that eliminating this barrier will increase access to lower-cost biosimilars and save payers and consumers billions over the next five years, as well as to enhance patient and physician confidence in biosimilars.

Of the bill, Sen. Lee said, ‘Our regulatory environment is making it too difficult and expensive for biosimilars to make it to the market. Ultimately, it’s the patients who suffer from a lack of competition and high drug prices. My bill, the Biosimilar Red Tape Elimination Act, would bring down the barriers preventing consumers from accessing these life-changing drugs.’

However, an interchangeable biosimilar is a unique biosimilar standard to the US, and the interchangeable biosimilar designation has successfully built physician and patient confidence. Weakening the standard for interchangeable biosimilars by applying it to all biosimilars – including those which have not provided additional data – would have immediate and harmful effects nationwide. according to the Alliance for Safe Biologic Medicines. 

Related articles
House bill passes FDA funding fees but conflicts with Senate bill

US Senate clarifies status of interchangeable biosimilar exclusivity 

Different approaches to the interchangeability of biosimilars

The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: Respuesta a Opinión sobre: Cuatro pasos para racionalizar el desarrollo de biosimilares

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: Respuesta a Opinión sobre: Cuatro pasos para racionalizar el desarrollo de biosimilares

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 


1. GaBI Online - Generics and Biosimilars Initiative. The US Biologics Competition Act and Biosimilar Red Tape Elimination Act [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 25]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilar Red Tape Elimination Act [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 25]. Available from: www.gabionline.net/policies-legislation/the-us-biologics-competition-act-and-biosimilar-red-tape-elimination-act
3. GaBI Online - Generics and Biosimilars Initiative. EMA calls for biosimilar interchangeability across the EU [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 25]. Available from:
4. GaBI Online - Generics and Biosimilars Initiative. UK updates guidance to allow biosimilars interchangeability [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 25]. Available from:

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