The Potential of Biosimilars
How do biosimilars offer a potential for greater savings and access across the health care system?
Addressing the challenges of the current US pharmaceutical landscape
In just 5 years, originator biologics were granted
77 new approvals1
(2015–2020)
And biologic products account for
And biologic products account for
43% of all US medicine spending2
(2019)
Could biosimilars help reduce costs to the health care system and help with patient access to biologics?
Evolving the health care system to help meet increasing demands
In 2019 alone, generic drugs saved the US health care system
~$313 BILLION3
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.
Generic share of US prescriptions by year3,5
What generics were to the US health care system in the 20th century is what biosimilars have the potential to become in the 21st century.5
Why biosimilars are being introduced—to help reduce biologic costs6
Through the adoption of biosimilars, it is estimated that the health care system could save
$104 BILLION from 2020 to 2024.2
As competition increases from biosimilar adoptions, the potential for significant savings to the health care system increases as well.7
Maintaining the balance between innovation and accessibility
Congress passed the Biologics Price Competition and Innovation Act (BPCIA) of 2009 with the goals of 8,9:
Facilitating biosimilar competition
- •By establishing a pathway to approval
Reducing health care costs
- •By potentially lowering the overall costs of biologics through the introduction of biosimilars
Increasing options
- •By offering greater access to medications
- •By expanding payer, provider, and patient choice
US Department of Health and Human Services (HHS) is taking steps to help address the challenges of access to and reimbursement of biosimilars, such as10:
- •Improving billing and payment code policies under Medicare Part B
- •Revising Medicare Part C and D regulations to help increase access to biosimilars
FDA’s Biosimilars Action Plan8
The FDA has laid out a multifaceted action plan to foster biologic innovation and further biosimilars development. Key measures range from the development and implementation of new FDA review tools to providing revised guidance on biosimilar topics and the establishment of a new Office of Therapeutic Biologics and Biosimilars (OTBB).
Governmental entities are actively engaged in helping to improve adoption of biosimilars across the US health care system.8,9
The future looks bright
When stakeholders throughout the health care system come together to achieve mutually beneficial goals, great things can happen. Biosimilar adoption could help lay the groundwork for future generations of breakthrough treatments.
Want more in-depth biosimilar education?
Biosimilars Overview
Interactive educational resource for anyone interested in understanding the biosimilars landscape.
Biosimilars Question and Answer Guide
Guide that explains what biosimilar medicines are, how they compare to originator biologics, and how they are approved.
About Biosimilars Video
Three-minute video for anyone who wants to learn about biosimilars.
FDA, US Food and Drug Administration.
References: 1. 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 April 5, 2021. https://www.fda.gov/media/89589/download 2. Aitken M, Kleinrock M, Muñoz E. Biosimilars in the United States 2020–2024: competition, savings, and sustainability. IQVIA Institute for Human Data Science report. September 29, 2020. Accessed April 5, 2021. https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2020-2024 3. Association for Accessible Medicines. Securing our access & savings: 2020 generic drug & biosimilars access & savings in the U.S. report. Accessed April 5, 2021. https://accessiblemeds.org/sites/default/files/2020-09/AAM-2020-Generics-Biosimilars-Access-Savings-Report-US-Web.pdf 4. Blackstone EA, Fuhr JP Jr. The economics of biosimilars. Am Health Drug Benefits. 2013;6(8):469–478. 5. US Food and Drug Administration. Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s biosimilars action plan. July 18, 2018. Accessed April 5, 2021. https://www.fda.gov/news-events/press-announcements/remarks-fda-commissioner-scott-gottlieb-md-prepared-delivery-brookings-institution-release-fdas 6. US Food and Drug Administration. Biosimilars drop-in articles. October 19, 2017. Accessed April 5, 2021. https://www.fda.gov/drugs/biosimilars/biosimilars-drop-articles 7. Mulcahy AW, Hlávka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. Accessed April 5, 2021. https://www.rand.org/content/dam/rand/pubs/perspectives/PE200/PE264/RAND_PE264.pdf 8. US Food and Drug Administration. Biosimilars action plan: balancing innovation and competition. July 2018. Accessed April 5, 2021. https://www.fda.gov/media/114574/download 9. US Food and Drug Administration. From our perspective: biosimilar product labeling. Updated July 18, 2018. Accessed April 5, 2021. 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 April 5, 2021. https://www.hhs.gov/sites/default/files/AmericanPatientsFirst.pdf
