More pro-biosimilar healthcare policies and RWE studies in the US

INICIO/Informes | Posted 01/12/2022 post-comment0 Post your comment

A 2022 report entitled ‘The U.S. Journey and Path Ahead’ provides perspective on where the US biosimilars industry stands today and what is expected in the future. The publication brought together the latest industry data on biosimilar utilization and payer coverage with survey data from healthcare providers, and thoughts from physicians and experts on biosimilars.

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The year 2022 included many significant biosimilar milestones and two of the predicted trends were more pro-biosimilar healthcare policies at both the federal and state levels as well as an increasingly turn to real-world evidence (RWE) by biosimilar manufacturers and commercial partners to demonstrate equivalency to providers and payers.

President Biden demonstrated in 2021 a great support for biosimilars. In addition to signing an Executive Order directing the US Food and Drug Administration (FDA) to make the biosimilar approval process more transparent, his administration also called for market changes that would promote biosimilars in a report outlining the administration’s recommendations on lowering the cost of prescription drug.

It is expected to see more pro-biosimilar focus in the future, including additional rulemaking by FDA – as well as Federal Trade Commission (FTC) action – to support competition and enhance consumer choice by preventing efforts by reference product manufacturers to delay or block competition from biosimilar and interchangeable products [1]. 

Besides, as states continue their efforts to lower drug costs, expecting to introduce policies that will broaden access to biosimilars in 2022, such as requiring health plans and pharmacy benefit managers to cover all versions of biological agents, including biosimilars. Another prediction indicated in the report is that biosimilars manufacturers and commercial partners will increasingly turn to RWE to demonstrate equivalency to providers and payers. 

While understanding of biosimilars among prescribers continues to grow, many healthcare providers still question whether biosimilars can deliver the same outcomes for patients as their reference products. As biosimilar manufacturers face increased pressure to demonstrate safety and efficacy, they will increasingly invest in RWE studies, which are not only less expensive to implement than randomized controlled trials, but also more representative of the patient populations in the real world. This data will be particularly relevant in ophthalmology, where there is limited RWE available. 

Looking beyond 2022, the successful adoption of biosimilars will not only create broader healthcare access and lower costs for patients, but also free healthcare dollars system-wide to enable more investment in advanced, innovative treatments, such as cell and gene therapies, with the potential to drive overall improvements in both rare diseases and public health.

Although there are still barriers to overcome, the promise of biosimilars outlined in the Biologics Price Competition and Innovation Act (BPCIA Act) are starting to be realized. And as momentum around biosimilars in the US continues to accelerate, patients will experience expanded benefits through broader access to and affordability of life-saving medications.

In the US prescription drug expenditure projection report, the authors also expressed confidence in recent US policy and legislation related to biosimilars, particularly when this concerns increasing knowledge and improving education on biosimilars [1].

In a series of two articles the new and upcoming biosimilar launches and Humira biosimilars pipeline were presented [2, 3].

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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 the latest headline article: Directrices para la regulación de biológicos, biosimilares y radiofármacos en Brasil

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.

Ver el último artículo de cabecera: Directrices para la regulación de biológicos, biosimilares y radiofármacos en Brasil

!Explore las noticias en el Foro Latinoamericano!

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


1. GaBI Online - Generics and Biosimilars Initiative. US prescription drug expenditure projection report []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Dec 1]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. New and upcoming biosimilars launches in the US []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Dec 1]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Humira (adalimumab) biosimilars pipeline []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Dec 1]. Available from:

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Source: Cardinal Health

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