President Biden signs ‘Advancing Education on Biosimilars Act’

INICIO/Políticas y legislación | Posted 04/06/2021 post-comment0 Post your comment

US President Joe Biden has signed the Advancing Education on Biosimilars Act of 2021, authorizing the Food and Drug Administration (FDA) to educate patients and healthcare providers about the benefits of biosimilars. This follows the reintroduction of the Bolstering Innovative Option to Save Immediately on Medicines Act  (BIOSIM Act), which will increase reimbursement for biosimilar drugs.

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There are 29 biosimilars approved in the US, almost two thirds of which have launched on the market [1]. However, there remains significant barriers to biosimilar uptake in the US, including payment policies that disincentivize the use of biosimilars, anti-competitive business strategies, and a lack of understanding among patients and healthcare professionals [2].

To address this last point, in April 2021 President Biden signed the Advancing Education on Biosimilars Act of 2021, which authorizes FDA to educate patients and healthcare providers on the benefits of biosimilars.

The Biosimilars Council, a division of the Association for Accessible Medicines which focuses on improving access to biosimilar medicines, welcomed the news. Executive Director Christine Simmon commented: ‘Education is a crucial step toward more widespread adoption of safe, effective and more-affordable biosimilar therapies. There is much work to be done in the United States to increase usage of biosimilars, stimulate competition and reduce prices for patients, and we look forward to working with our counterparts at the Food and Drug Administration to inform providers and patients about the benefits that biosimilars bring to the market’.

Other efforts to improve biosimilar access include the reintroduction of the BIOSIM Act on April 23, 2021. This bipartisan Act provides for increased reimbursement to hospitals and physicians for biosimilar drugs for a period of five years. Specifically, the Act will increase biosimilar reimbursement in Medicare Part B (under which providers receive reimbursement for dispensing based on the average sales price [ASP] of the drug) to the ASP of the drug plus 8%.

Christine Simmon also supported this news, saying: ‘By modestly boosting reimbursement to healthcare providers using biosimilars, the BIOSIM Act will encourage faster adoption of these novel treatments and deliver savings for providers and patients’.

Other ways to increase the use of biosimilars in the US were suggested in a new IQVIA report ‘Biosimilars in the US: reimbursement and impacts to uptake’, published in March 2021. The report shows that biosimilars are more likely to be used when relative reimbursement to physicians (the difference between the reimbursement for the product and its acquisition cost) is higher for the biosimilar. It also found that biosimilar adoption was higher for providers in the CMS Oncology Care Model, in which providers are accountable for the total cost of care.

The report suggests that Medicare payment policies should reward the use of biosimilars over more expensive, brand-name biologicals. They suggest, for example, that the Medicare Part B add-on payment be increased for biosimilars. Similarly, the Medicare Part D programme (which helps to cover the cost of prescription drugs) could be updated to encourage health plans to prioritize the use of biosimilars.

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US guidelines for biosimilars

The sluggish US biosimilars market


To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

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



Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 4]. Available from: 
2. GaBI Online - Generics and Biosimilars Initiative. US policy brief identifies barriers to biosimilars uptake []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 4]. Available from:

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