USA BIOSIM Act introduction

INICIO/Políticas y legislación | Posted 17/09/2021 post-comment0 Post your comment

The Bolstering Innovative Option to Save Immediately on Medicines Act (BIOSIM Act) was introduced in the US on 22 April 2021. This hopes to encourage greater uptake and use of biosimilar therapies by increasing biosimilar reimbursement for healthcare providers in Medicare Part B [1]. 

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On average, biosimilars offer cost reductions of 30% compared to brand-name products. With appreciable uptake, the Biosimilars Council, a division of the Association for Accessible Medicines (AAM), has stated that biosimilar competition could provide cost savings for the US healthcare system of up to US$130 billion by 2025. This will ensure that patients have greater access to life saving biological drug products.

If signed into law, the bipartisan BIOSIM Act hopes to accelerate patient access to new lower-cost biosimilar treatments by providing a temporary (five year) payment increase to clinicians that prescribe them. The act will provide an add-on payment of 8% for providers when they use a lower-cost biosimilar (an increase of 2%). The policy only applies when the price of a biosimilar is less than that of the brand-name reference biological.

However, under Medicare Part B, healthcare providers are not incentivized to offer lower-cost biosimilar products to patients as they are reimbursed the average sales price (ASP) of the brand-name biological and biosimilar, plus an additional 6% of the cost of the brand-name biological. Despite this, several studies have shown that offering greater reimbursement does lead to increased biosimilars uptake. As such, the new legislation hopes to boost competition with brand-name biologicals, reducing treatment costs for both patients and taxpayers and increasing access to medicines.

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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: Requisitos de certificación de BPF en Argentina, Brasil y México

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.


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: Requisitos de certificación de BPF en Argentina, Brasil y México

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. 

1. GaBI Online - Generics and Biosimilars Initiative. President Biden signs Advancing Education on Biosimilars Act []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 17]. Available from: 

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