The US introduced the Biologics Competition Act of 2022 (HR 887) in September 2022. This was followed by the introduction of the Biosimilar Red Tape Elimination Act in November 2022. Both acts seek to make biosimilar products more accessible and increase their uptake in the US.
The Biologics Competition Act of 2022 is a bipartisan act introduced by Representatives Mariannette Miller-Meeks, MD, R-Iowa; Greg Murphy, MD, R-North Carolina; Nanette Barragán, D-California; and Ann Kuster, D-New Hampshire. Whereas the Biosimilar Red Tape Elimination Act was introduced by Senator Mike Lee R‑Utah.
The Biologics Competition Act Biologics of 2022 sets out to direct the Secretary of Health and Human Services (HHS) on the evaluation of process by which interchangeable biological products are approved. Specifically, the secretary of HHS is directed to complete a study evaluating how substitution of interchangeable biological products may be impeded, within a year of the act passing. A report will then be submitted to Congress on the results of the study. In addition, the HHS is required to make updates to the Purple Book (searchable, online database that contains information about biological products) to align communication of substitutability of interchangeable products with communication about therapeutic equivalence ratings.
In the US, biosimilars approved and granted interchangeable status can be substituted at the pharmacy level without the approval of the prescriber (similar to generics) [1]. To acquire interchangeable status, the biosimilar must undergo additional switching studies and these are expensive and time consuming, which creates a barrier to interchangeable approval. The Biosimilar Red Tape Elimination Act removes the requirement for these switching studies. Eliminating this barrier increases access to lower cost biosimilars and has potential to save payers and consumers billions of dollars.
To date, only three biosimilars have been granted interchangeability status. The first was Semglee (insulin glargine-yfgn) approved on 28 July 2021 [2]; the second, Cyltezo (adalimumab-adbm) approved on 15 October 2021 [3]; and the third, Cimerli (ranibizumab-eqrn) approved on 2 August 2022 and is the first interchangeable ophthalmology biosimilar approved [4].
It is hoped that together, these acts will improve access to biosimilars, which offer more affordable treatment options to US citizens.
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA releases new information on interchangeable biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 27]. Available from: www.gabionline.net/biosimilars/general/FDA-releases-new-information-on-interchangeable-biologicals
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 27]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-insulin-glargine-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Cyltezo as interchangeable[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 27]. Available from:
www.gabionline.net/biosimilars/news/fda-approves-adalimumab-biosimilar-cyltezo-as-interchangeable
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable ranibizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 27]. Available from:
www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-ranibizumab-biosimilar
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