FDA Releases New Biosimilars Education Materials for Patients

Wednesday October 2, 2019

When it comes to ensuring medicines  — including biosimilars — are safe and effective for patients, the FDA remains the global gold standard. The agency also is the most authoritative resource for unbiased, science-based information on prescription drugs. So when patients and other health care stakeholders access the FDA’s newly released educational materials on biosimilars, they can be confident that the content will be both accurate and helpful.

In this most recent suite of materials, “Biosimilars Basics for Patients,” FDA breaks down complex topics into easily understandable concepts on a new section of its website dedicated to patients and in an infographic to help increase awareness and understanding of these important types of medications.

As  FDA’s new educational materials explain, “Biosimilars are like generics in some ways, in that both types of medications are compared to a reference (original) product for approval. Biosimilars and generics are both versions of previously FDA-approved medications and may offer more affordable treatment options to patients.” This means you can expect the same safety and effectiveness from the biosimilar over the course of treatment as you would the reference product.

With the introduction of biosimilar competitors, more patients gain access to biologic treatments, driving better outcomes for patients battling life-threatening or debilitating diseases, at a more competitive cost than brand-name biologics. Health care professionals utilizing biosimilars have access to a wider spectrum of treatment options and reduced pressure on their budgets. Payers benefit from a competitive market with a broad range of cost-effective treatment options. This competition creates potential savings on prescription drugs across entire health care systems. Reducing costs is one reason Congress created the FDA approval pathway for biosimilar medications.

FDA’s leadership and commitment to the development of non-biased educational resources has been essential to fostering acceptance and utilization of these therapies, and to correcting misinformation. Congress has also supported these efforts.

To learn more about biosimilars, stay tuned to our blog for updates, or check out our Biosimilars Handbook.

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 22 percent of total drug spending.

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 at www.biosimilarscouncil.org.

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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.