Affordable Care Act and the Future of Biosimilars

Tuesday November 10, 2020

Today, the U.S. Supreme Court will hear arguments on the constitutionality of the Affordable Care Act (ACA). Although the case relates to the individual insurance mandate contained in the law, it could affect more than just this question. In fact, a recent analysis of the biosimilars market highlights how this case could affect the affordability of lifesaving biologic medicines for America’s patients.

While the individual mandate, protections for individuals with pre-existing conditions, and creation of the health exchanges are often the most discussed portions of the ACA, the law is actually quite extensive and contains provisions that go well beyond these items. Notably, the ACA includes the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA created a pathway for FDA to review and approve biosimilar medicines, which are lower-cost versions of pricey biologics.

Thus far, the FDA has approved 28 biosimilars, with 18 currently on the U.S. market. These medicines are entering the market at an average price that is approximately 30% lower than the price of the reference biologic. In fact, U.S. biosimilars savings are growing steadily, totaling $2.2 billion in 2019 and $4.5 billion over the past 10 years. Furthermore, the availability of biosimilars improves access. IQVIA recently reported that the availability of biosimilars has led to increases in overall volume. Put simply, this means that more patients are receiving these medicines as a result of biosimilar competition.

For example, the molecule filgrastim saw a nearly 5% incremental volume increase. Patients for whom a biological therapy was previously out of reach are now able to receive needed treatment. These figures are consistent with the Biosimilars Council’s previous analysis projecting that as many as 1.2 million new patients suffering from cancer or autoimmune diseases will receive therapy because of new biosimilar competition. 

As the U.S. Supreme Court considers the California v. Texas case today, AAM and its Biosimilars Council have called on the Court in an amicus brief to sever the BPCIA if the ACA’s individual mandate is found unconstitutional. We argued that: 

  • The BPCIA was enacted to promote the development of affordable, life-saving drugs; 
  • There is a presumption in favor of severability; 
  • The BPCIA is not connected to the insurance provisions or the Individual Mandate in the ACA; 
  • BPCIA went through an extensive legislative process before it was incorporated into ACA; 
  • The BPCIA stands on its own, independent of the Individual Mandate; and 
  • The Plaintiffs lack standing to challenge the BPCIA 

AAM and its Biosimilars Council will continue to monitor this case and develop strategies to address any of the several potential outcomes.

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 20 percent of total drug spending.

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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.