Association for Accessible Medicine’s Biosimilars Council Releases Roadmap for Biosimilars Market Development in U.S.

Wednesday May 30, 2018

“Breaking Through on Biosimilars: Delivering More-Affordable, Innovative Medicines for America’s Patients” Recommends Policies to Fulfill Promise of Biosimilars

(Washington, D.C. –  May 30, 2018) – The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), today released a white paper offering policy recommendations to promote the development of a robust biosimilars market in the United States. “Breaking Through on Biosimilars: Delivering More-Affordable, Innovative Medicines for America’s Patients,” highlights the current regulatory, legislative, market and education challenges to ensuring patients gain access to these innovative, life-saving treatments.

Biosimilars, biologic medicines approved by the United States Food and Drug Administration (FDA) as alternatives to existing brand biologic drugs, are safe, effective and cost-saving treatments. It has been estimated that FDA-approved biosimilars could save patients and the health care system between $54 and $250 billion over their first 10 years on the market.[1],[2]

Yet, America’s patients currently have access to just three of the 10 approved United States biosimilars. Biosimilars approvals here currently trail well behind Europe, which has approved more than 40 biosimilars in the past decade and accumulated more than 700 million patient days of experience with these medicines. Prolonged patent litigation and “stacked rebates” are among the roadblocks to additional product launches in the U.S. market that are designed to thwart patient access, as detailed in the white paper.

“Biosimilars hold great promise as a solution for the growing number of patients on increasingly expensive brand biologic medicines. However, this nascent industry is at a ‘make or break’ point. This paper is an essential resource for policymakers seeking to foster a regulatory and legislative landscape that promotes biosimilars market growth by aligning incentives for competition and development,” says Christine Simmon, Executive Director of the Biosimilars Council and Senior Vice President of Policy and Strategic Alliances at AAM. “America’s patients deserve access to innovative treatment options, including biosimilars.”

“Breaking Through on Biosimilars: Delivering More-Affordable, Innovative Medicines for America’s Patients,” provides solutions to current challenges in biosimilars market development including:

  • Hurdles intended to thwart competition, such as restricted access to reference products, patent abuses and trade agreement provisions that extend monopolies;
  • Obstacles to market-based competition once the FDA has approved an application, including naming, labeling and interchangeability rules, and reimbursement issues; and
  • Efforts to disseminate misinformation to patients and health care professionals to slow biosimilar uptake.

To access the full whitepaper, please visit:

Rachel Schwartz 
202.249.7147 (o)
202.251.8881 (c)

[1] Mulcahy, Andrew W., Jakub P. Hlavka, and Spencer R. Case, Biosimilar Cost Savings in the United States: Initial Experience and Future Potential. Santa Monica, CA: RAND Corporation, 2017 Accessed April 30, 2018.

[2] The $250 Billion Potential of Biosimilars, Express Scripts International (April 23, 2013). Available at: 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

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