Biosimilars are a
In the U.S., Biosimilars could lead to over $130 billion is savings by 2025, and have been used in over 364 million days of patient therapy.
Save the Date for GRx+Biosims 2024
GRx+Biosims™ 2024 is the premier regulatory science and policy event for the U.S. generics and biosimilars industry. Get the latest information directly from Food and Drug Administration experts, understand the latest policy that impacts the industry and gain valuable insights to advance your professional development. Learn More
2023 U.S. Generic and Biosimilar Medicines Savings Report
New findings in the 2023 U.S. Generic & Biosimilar Medicines Savings Report show savings for generics and biosimilars continue to grow with $408 billion saved in 2022 for patients, consumers, employers and taxpayers. Representing 90% of Rx filled but less than 18% of spending, generics and biosimilars are an integral part of the U.S. health care system. Read full report.
Advocacy
The Biosimilars Council advocates to increase patient access to lifesaving, affordable biosimilar medicines.
Our members include manufacturers and stakeholders working to develop biosimilar medicines for the U.S. market
Biosimilars approved in the U.S.
$180
Billion in potential savings for patients and payers
694
Million total days of patient therapy where biosimilars were used
Million incremental days of therapy
The Benefits of Biosimilars
Expanding access to biosimilars has proven successful in driving down the cost of life-saving therapies.
This increases access to needed medications for patients, strengthens our economy and benefits our society.
View resources for:
Biosimilars Timeline
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2010 Passage of BPCIA
The Biologics Price Competition and Innovation Act (BPCIA), enacted in 2010, provided a framework for biosimilars approval, adoption and access in the U.S. How did we get there?
- 1980s: The first biological medicinal products produced by DNA recombinant techniques are approved
- 1986: First monoclonal antibody receives FDA approval
- 1998: First biologic for rheumatoid arthritis is introduced: Omnitrope
- Learn more about biologics vs biosimilars
- Find out more on biological products
- Learn more about biosimilars
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2014 First FDA Guidance Issued
Guidance documents represent FDA’s current thinking on a topic. The FDA’s first guidance on biosimilars was issued in 2014 on the Development and Approval of Biosimilar Products in the U.S., creating clear regulatory expectations for biosimilar products. This guidance provides information on developing biosimilarity, safety and efficacy.
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2015 First U.S. biosimilar approved: Zarxio
In March 2015, the FDA approved its first biosimilar, Zarxio (filgrastim-sndz) for patients with cancer receiving chemotherapy and radiation to support white blood cell creation. Sandoz was the first company to receive approval of a biosimilar in the U.S. through the new FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act.
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2015-2020 Increasing Access through Biosimilar Policy
Congress and multiple government agencies have played a large part in the growth of biosimilars. Through continuing to issue FDA guidance for industry, providing clearer guidelines on biosimilar approval and creating new pathways for biosimilar access and reimbursement, government agencies have helped paved the way for biosimilar success.
- 2015: FDA Final Guidance issued on demonstrating biosimilarity with a reference product
- 2016: FDA Final Guidance issued on naming and labeling for biosimilar products
- 2017: Centers for Medicare & Medicaid Services issues policy on biosimilars reimbursement, giving each biosimilar its own average sales price.
- 2019: Bipartisan members of Congress introduced multiple pieces of legislation to incentivize biosimilar use and adoption
- Learn more about biosimilars policy
- Stay in the loop on biosimilars policy
- Find out more on regulating biosimilars
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2018 RAND Report Projects Billions in Savings
U.S. research institution RAND report finds that biosimilars could save the U.S. health care system more than $54 billion in savings over the next 10 years and offer access for needed treatments to over 1.2 million patients.
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2018 A Push for Patient Access
Momentum builds for more biosimilar approvals and greater access and to fight anticompetitive tactics from brand biologic companies. With the creation of the Biosimilars Action Plan in June 2018, FDA pledges to propel biosimilars forward for the sake of America’s health care system and patients.
- What was the Biosimilars Action Plan?
- Read the Biosimilars Council comments on Pfizer’s petition
- See what physicians have to say about biosimilars
- https://biosimilars.staging.wpengine.com/resource/biosimilars-facts/
Resources:
- Failure to Launch White Paper Series:
- FDA patient education materials
- Biosimilars education course for clinicians
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2019 A Watershed Year for Biosimilars
A record 10 FDA biosimilar approvals and increased uptake and utilization rates by payers characterize the most concrete progress yet.
- Record number of FDA approvals: 10
- Record number of products launched
- May 2019: FDA Final Guidance issued on interchangeable biosimilars
- November 2019: FDA issues draft guidance on insulin biosimilars
- October 2019: World Health Organization (WHO) and International Generic Biosimilar Medicines Association (IGBA) sign memorandum of understanding to encourage and promote biosimilars access worldwide
- Learn more about the biggest year yet for biosimilars
- Learn more about increasing access to insulin biosimilars
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The Next Ten Years A Bright Future for Biosimilars
Biosimilar adoption in the U.S. health care system is within reach. To ensure continued success of biosimilars for the next 10 years and beyond is dependent on the decisions made today. While approvals have increased access and use have not.
Increasing biosimilar availability could provide as many as 1.2 million U.S. patients access to lower cost treatment options by 2025. The events of 2020 have made it clear that health care solutions are needed that improve patient access to medicines and increase savings for the entire U.S. health care system. Biosimilars are an essential part of this reform. Fulfillment of the biosimilar promise can happen if we educate the medical profession as well as federal and state policymakers.
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Recent Blogs & Resources
What Patients Are Saying
Expanding access to biosimilars has proven successful in driving down the cost of life-saving therapies.
“Because I have an incurable form of non-Hodgkin lymphoma, I know my medication journey will continue. It is nice to know that when I need a biosimilar again, it will be there for me.”
Helen, 41, Florida
Listen to their stories.
You Can Make A Difference
As the role of biosimilar medicines in our health care system continues to grow, it is essential that patients advocate for affordable biosimilars with their lawmakers. Subscribe to the Biosimilars Bulletin and for alerts on policies that affect your access to these life-saving medicines.