What are biosimilars?

Monday September 21, 2020

Biosimilars are biologic medicines that are highly similar to a previously approved reference biologic currently on the market. But what does that short definition of a biosimilar actually mean?

Approved biosimilars on the market are safe, effective and are more competitively priced alternatives to brand name biologic medicines. These medicines have scientifically comparable quality to the reference brand biologic and retain high-quality safety standards. Biosimilars bring the same lifesaving treatments to patients battling cancer and other chronic illnesses, such as multiple sclerosis, diabetes, rheumatoid arthritis and Crohn’s disease, as brand name biologics, but present the opportunity for greater availability and a more competitive cost.  Biosimilars are important because, much like generic drugs, they have an opportunity to create competition in the market, potentially drive down costs and expand patient access to critical medicines.

An interchangeable product, in addition to being biosimilar, meets additional requirements based on further evaluation and testing of the product. A manufacturer of a proposed interchangeable product will need to provide additional information to show that an interchangeable product is expected to produce the same clinical result as the reference product in any given patient.

There are many benefits of biosimilars. With biosimilars, a greater number of patients gain access to biologic treatments earlier in their therapy cycle, driving better outcomes for patients battling life-threatening or debilitating diseases, at a potentially lower 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 savings on prescription drugs across entire health care systems.

The Biosimilars Council has worked to promote the development of biosimilars and pave the way for inclusive biosimilar legislation, as well as provide patients, providers and policymakers with adequate, educational biosimilars resources.

To join the conversation and learn more about biosimilars, check out our advocacy page, stay tuned to our blog for updates, or check out our Biosimilars Handbook.

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.accessiblemeds.org.

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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.