On 17 June 2021, the US Supreme Court ruled to uphold the Affordable Care Act (ACA) and Obamacare. This ensures the current pathway for biosimilars to reach the US market will be maintained which will provide access to cheaper versions of expensive biological therapies.
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) is included in ACA, and this allows drugmakers to get biosimilars to market without the need for extensive clinical trials. The BPCIA contains the blueprint for US Food and Drug Administration (FDA) biosimilars approvals.
In a statement, Meaghan Rose Smith, Executive Director of the Biosimilars Forum, said, ‘This is a key a provision critical to lowering drug costs and expanding patients access to lifechanging treatments’.
Considering this court decision, many are calling for legislative changes to improve the biosimilars route to market. At present, products may be approved by FDA but face a series of hurdles before entering the market. Delays in commercialization are often due to anti-competitive behaviours and patent-related barriers created by manufacturers of branded originator drugs [1]. Once they have entered the market, there are then also considerable barriers to uptake, including anti-competitive strategies and a lack of education of patients and healthcare professionals.
This news follows President Joe Biden’s early June signing of the Advancing Education on Biosimilars Act of 2021, which authorizes FDA to educate patients and healthcare providers about the benefits of biosimilars. In turn, this came after the reintroduction of the Bolstering Innovative Option to Save Immediately on Medicines Act (BIOSIM Act), which is set to increase reimbursement for biosimilar drugs [2].
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| LATIN AMERICAN FORUM The brand-new section 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 this week’s headline article: Biosimilares en Japón: una perspectiva general 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. 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 esta semana: Biosimilares en Japón: una perspectiva general Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.
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References
1. GaBI Online - Generics and Biosimilars Initiative. A positive outlook for the US biosimilars market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 9]. Available from: www.gabionline.net/biosimilars/research/A-positive-outlook-for-the-US-biosimilars-market
2. GaBI Online - Generics and Biosimilars Initiative. President Biden signs Advancing Education on Biosimilars Act [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 9]. Available from: www.gabionline.net/policies-legislation/President-Biden-signs-Advancing-Education-on-Biosimilars-Act
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