This site is intended for U.S. health care professionals.
This site is intended for U.S. health care professionals.

The potential
of biosimilars

We believe that biosimilars could offer significant benefits to the health care system, from increased competition to reduced costs.1,2

Biologic cost challenges

In just 5 years,
originator biologics were granted
77new approvals3
(2015-2020)
Biologic products account for
43%
of all US and medical spending1
(2019)

Could biosimilars help reduce costs to the health care system and help with patient access?

How generics did it

In 1984, Congress established the Drug Price Competition and Patent Term Restoration Act (“Hatch-Waxman”) to encourage competition and provide incentives for pharmaceutical innovators to develop new drugs.4 The influence of Hatch-Waxman wasn’t felt overnight.5 Working together now, we may help make an impact with biosimilars sooner.

In 2019 alone, generic drugs saved
the US health care system

~$313 BILLION6

We believe biosimilars could be to the 21st century what generics were to the 20th: a paradigm shift that may deliver more competition, increase treatment options, and help lower costs to the health care system.5

Generic share of US prescriptions by year5,6:

  • 13% in 1983
  • 90% in 2020

Why are biosimilars being introduced—to help reduce biologic costs7

Biosimilars and public policy

Various government bodies have played a role in incentivizing research and driving biosimilar adoption, ensuring a balance between innovation and accessibility.

In 2010, Congress passed the Biologics Price Competition and Innovation Act

to facilitate biosimilar competition, reduce health care costs, and expand choice and access to medications8,9

The Department of Health and Human Services (HHS) is taking steps to help address the challenges of access

to and reimbursement of biosimilars, such as improving billing and payment code policies under Medicare Part B and revising Medicare Part C and D regulations10

The FDA has laid out a multifaceted action plan to foster biologic innovation

and biosimilars development, including developing and implementing new review tools and establishing a new Office of Therapeutic Biologics and Biosimilars (OTBB)8

The future of biosimilars looks bright

When the health care community works together to achieve mutually beneficial goals, great things can happen. Biosimilar adoption could help improve competition, lower health care system costs, and expand choice and access to biologic medications.

Want more in-depth biosimilar education?

Biosimilars overview

Interactive educational resource for anyone interested in understanding the biosimilars landscape.

Biosimilars overview
DownloadLearn more

Biosimilars question and answer guide

Guide that explains what biosimilar medicines are, how they compare to originator biologics, and how they are approved.

Biosimilars question and answer guide
Download Spanish PDFDownload English PDF

Get familiar with Biosimilars

One-minute video introducing biosimilars, their purpose, and potential impact.

References: 1. Aitken M, Kleinrock M, Muñoz E. Biosimilars in the United States 2020–2024: competition, savings, and sustainability. IQVIA Institute for Human Data Science. September 29, 2020. Accessed March 2, 2023. https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2020-2024 2. Aitken M, Mugele D, Newton M, Rodríguez I, Vázquez M. Spotlight on Biosimilars. IQVIA Institute for Human Data Science. June 2021. Accessed May 8, 2023. https://www.iqvia.com/insights/the-iqvia-institute/reports/spotlight-on-biosimilars 3. Center for Drug Evaluation and Research. List of licensed biological products with (1) reference product exclusivity and (2) biosimilarity or interchangeability evaluations to date. September 9, 2014. Updated August 3, 2020. Accessed March 2, 2023. https://www.fda.gov/media/89589/download 4. Blackstone EA, Fuhr JP. The economics of biosimilars. Am Health Drug Benefits. 2013;6(8):469-478. 5. Stark A. Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilar Action Plan. US Food and Drug Administration (FDA). July 18, 2018. Accessed March 2, 2023. https://www.fda.gov/news-events/press-announcements/remarks-fda-commissioner-scott-gottlieb-md-prepared-delivery-brookings-institution-release-fdas 6. Association for Accessible Medicines. Securing our access & savings: 2020 generic drug & biosimilars access & savings in the U.S. report. Accessed March 2, 2023. https://accessiblemeds.org/sites/default/files/2020-09/AAM-2020-Generics-Biosimilars-Access-Savings-Report-US-Web.pdf 7. US Food and Drug Administration. Biosimilars drop-in articles. October 19, 2017. Accessed March 2, 2023. https://www.fda.gov/drugs/biosimilars/biosimilars-drop-articles 8. US Food and Drug Administration. Biosimilars action plan: balancing innovation and competition. July 2018. Accessed March 2, 2023. https://www.fda.gov/media/114574/download 9. US Food and Drug Administration. From our perspective: biosimilar product labeling. Updated July 18, 2018. Accessed March 2, 2023. https://www.fda.gov/drugs/news-events-human-drugs/our-perspective-biosimilar-product-labeling 10. US Department of Health & Human Services. American patients first: the Trump administration blueprint to lower drug prices and reduce out-of-pocket costs. May 2018. Accessed March 2, 2023. https://www.hhs.gov/sites/default/files/AmericanPatientsFirst.pdf