White Paper: Breaking Through on Biosimilars

Wednesday May 30, 2018

The Biosimilars Council - Breaking through on Biosimilars Whitepaper Cover

America’s patients who suffer from many complex and chronic diseases have promising new treatment options in biologic and specialty medicines. But too often these medicines are extremely expensive, creating challenges to patient access. Now, thanks to biologic medicines known as biosimilars, these advanced treatments are becoming available at a lower cost to millions of patients in the United States living with cancer, rheumatoid arthritis, Crohn’s disease, anemia, psoriasis and other conditions.

Click the button below to download the Biosimilars Council’s whitepaper, where you will learn about:

  • Challenges to Bringing a Biosimilar to Market
  • Reimbursement and Market Access,
  • Building the Biosimilars Marketplace, and much more

Download White Paper

Executive Summary

As America’s patients seek access to more-affordable versions of biologic medicines to treat their complex and chronic diseases, biosimilars offer a much-needed alternative. Today, just 2 percent of the U.S. patient population uses biologics, yet they account for 26 percent of national prescription drug spending, a record $453 billion in 2017.[1] Utilization of these innovative and very costly medicines is expected to grow exponentially in the coming years. But thanks to new biologic medicines known as biosimilars, these advanced treatments are poised to become available at a lower cost to millions of patients in the United States.

The Biosimilars Council - Biologics Net Spending US $billions

Whether the promise of biosimilars will be fulfilled for patients is largely dependent on a regulatory, legislative and market landscape for biosimilars that encourages competition and biosimilar development so that America’s patients can benefit from these life-saving therapies.

Data from Europe indicate what biosimilars mean for patients. Access to both biosimilars and biologics has increased by as much as 100 percent in Europe as the result of biosimilars availability.[2] In the U.S., biosimilars will provide greater access to biologic medicines for an additional 1.2 million patients over the next 10 years, according to a recent study.[3]

However, the U.S. trails Europe – with only 10 approved biosimilar medicines, compared to more than 40 in Europe. Only three of the FDA-approved biosimilars are available to patients in the United States.[4]

The biosimilar medicines development process requires substantial financial investment, on average estimated to cost between $100 and $300 million per product.[5] FDA Commissioner Gottlieb recently highlighted the importance of fostering the development of a strong biosimilars market, saying: “The public health benefits of a robust, competitive market for biosimilars are impossible for us to ignore. Strong market incentives are critical to future biosimilar development in the same way these incentives are key for the development of innovator drugs and biologics.”[6]

As the paper discusses, biosimilar manufacturers face regulatory uncertainty and anti-competitive market access tactics designed to prevent competition from lower-cost products. Only through dedicated policymaker attention and unbiased safety and efficacy information for patients and providers will the full promise of lower-cost, life-saving biosimilar medicines be fulfilled for patients and the U.S. health care system.

Download The Executive Summary


[1] IQVIA Institute for Human Data Science: “Medicine Use and Spending in the U.S.: A Review of 2017 and Outlook to 2022.” (April 2018)

[2] IMS Institute for Healthcare Informatics, Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets, (March 2016). Available at: https://bit.ly/2eTu1NP.

[3] Avalere Health and The Biosimilars Council, Biosimilars in the United States: Providing More Patients Greater Access to Lifesaving Medicines. (2017)

[4] As of May 2018

[5] CNBC Interview of FDA Commissioner Gottlieb, March 28, 2018. Accessed: April 30, 2018. Available at: https://cnb.cx/2pNVVlh.

[6] FDA Commissioner Gottlieb Speech: “Capturing the Benefits of Competition for Patients,” March 7, 2018. Available at: https://bit.ly/2FuFxjN. Accessed April 30, 2018.

About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available on our about page.

About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 23 percent of total drug spending. Additional information is available at www.accesiblemeds.org.

Stay Informed

Subscribe for Updates

Receive our monthly Biosimilars Bulletin and other important updates on biosimilars in the U.S.


Get Involved

The Council is involved in a number of events that focus on advancing biosimilars in the United States. Click on one below to learn more:



October 21–23, 2024 | Rockville, MD

GRx+Biosims™ 2024 is the leading regulatory science and policy event for the U.S. generics and biosimilars industry. Access the most recent information straight from experts at the Food and Drug Administration, grasp the latest policies shaping the industry, and acquire valuable insights to propel your professional development.