US Republican Senator for Utah, Mike Lee, has introduced an updated ‘Biosimilar Red Tape Elimination Act.’
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.
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References
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:
www.gabionline.net/policies-legislation/the-us-biologics-competition-act-and-biosimilar-red-tape-elimination-act
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:
www.gabionline.net/biosimilars/general/ema-calls-for-biosimilar-interchangeability-across-the-eu
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:
www.gabionline.net/guidelines/uk-updates-guidance-to-allow-biosimilars-interchangeability
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