HHS new study on biosimilar use and expanded trials will include older patients

Biosimilares/General | Posted 29/04/2022 post-comment0 Post your comment

In March 2022, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced that it will launch a study on biosimilars use and spending trends in Medicare Part B. The US Food and Drug Administration (FDA) has also made changes to clinical trials to improve information available on use of biosimilars in older patients.

Clinical trial PainSA V21F04

Biosimilar products have been developed and introduced globally, with the promise of offering lower price alternatives to reference branded originator products enabling increased access to these vital biological medicines. In the US, Medicare Part B pays for some physician-administered drug products for patients, however, as has been evidenced by a number of studies [1-5], the uptake of biosimilars in the US remains relatively low. HHS officials have cited the lack of provider reimbursement incentives as a possible obstacle to biosimilar uptake.

The HSS OIG has outlined that the new study will track the spending trends on biosimilars and their originator products covered by Medicare Part B over time. it has previously been noted that most of Medicare Part B spending is on a relatively small number of products, many of which are biologicals and not biosimilars [6]. It will focus on trends in 2021 and determine the amount of money that could have been saved with increased biosimilar uptake, and other reimbursement policies. The study is due to start in 2023 and hopes to highlight barriers to uptake so that changes can be made to help biosimilars reach their full cost-saving potential. It has recently been highlighted that this could mean savings in excess of US$100 billion [7].

In addition, FDA has also updated its guidance for clinical trials, which now includes recommendations for the increased representation of older adults in clinical trials testing potential cancer treatments. There is particular emphasis on the ‘older adults’ being those over the age of 75. Patients over 65 now represent a growing proportion of those requiring cancer treatment. It is hoped that these updates will enable better evaluation of the benefits of a drug against the risks of its use in this more aged population. It will also increase the generalizability of clinical trial results.

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LATIN AMERICAN FORUM

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 last week’s headline article: Nomenclatura de biológicos y biosimilares en Chile

Browse the news in the Latin American Forum!

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LATIN AMERICAN FORUM

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.

Vea el artículo principal de la semana pasada: Nomenclatura de biológicos y biosimilares en Chile

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

  

References
1. GaBI Online - Generics and Biosimilars Initiative. President Biden signs ‘Advancing Education on Biosimilars Act’ [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/policies-legislation/President-Biden-signs-Advancing-Education-on-Biosimilars-Act
2. GaBI Online - Generics and Biosimilars Initiative. The US needs to learn from Europe to increasing access to biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/biosimilars/research/the-us-needs-to-learn-from-europe-to-increasing-access-to-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar launches and uptake expected to increase in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/reports/biosimilar-launches-and-uptake-expected-to-increase-in-the-us
4. GaBI Online - Generics and Biosimilars Initiative. USA Biosim Act introduction [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/policies-legislation/usa-biosim-act-introduction
5. GaBI Online - Generics and Biosimilars Initiative. How to support a viable US biosimilars market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/reports/How-to-support-a-viable-US-biosimilars-market
6. GaBI Online - Generics and Biosimilars Initiative. A few drugs account for most of Medicare Part B spending [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/reports/a-few-drugs-account-for-most-of-medicare-part-b-spending
7. GaBI Online - Generics and Biosimilars Initiative. US savings from biosimilars could exceed US100 billion [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/reports/us-savings-from-biosimilars-could-exceed-us-100-billion

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