Biosimilars Facts

Tuesday December 22, 2020

Biosimilar medicines are safe, effective alternative versions of existing brand biologic medicines (known as “reference products”) with scientifically comparable quality, safety and effectiveness. A biosimilar is highly similar to a brand biologic and made of the same types of natural sources as the reference product, providing the same treatment benefits. In the United States, there are 25+ FDA-approved biosimilars helping patients with common-but-difficult-to-treat diseases including cancer and arthritis and other inflammatory diseases. Biosimilars provide important competition for expensive biologic medicines, which can help lower costs for patients, taxpayers and insurers and increase access to lifesaving medications.

biosimilars are safe

Biosimilars Are Safe

Biosimilars undergo rigorous FDA testing, review and safety monitoring. The biosimilars development process is complex and companies that manufacture biosimilars are committed to providing safe, effective products to patients. To obtain FDA approval, a biosimilar must have the same route of administration, dosage form and strength as the biologic medication.

An interchangeable product is a biosimilar that meets additional requirements outlined by the Biologics Price Competition and Innovation Act (BPCIA). These additional standards do not mean that the interchangeable product is better or of a higher quality than an FDA-approved biosimilar. A product approved as an interchangeable product means that FDA has concluded it may be substituted for the reference product without consulting the prescriber.

biosimilars are effective

Biosimilars Are as Effective as Brand Biologics

Patients in Europe have been using biosimilars for 10+ years, resulting in more than 700 million days of safe, effective use. Biosimilars are more affordable and offer improved patient access. It doesn’t add up for forces to keep safe, effective and affordable generic and biosimilar medicines from being approved and accessible to patients.

biosimilars are affordable

Biosimilars Can Save Patients Money

The average daily cost of a biologic is approximately 22 times greater than the daily cost for a traditional medicine, making safe and effective solutions an imperative for patients. Experts estimate that biosimilars will be priced 10 to 35% less than their brand-name drug competitors. This means patients could save as much as $54 billion in the next decade. Patients, taxpayers and the health care system are bearing the costs of patent schemes and tactics delaying access to biosimilars. Delayed entry of biosimilars due to litigation stemming from “patent thicketing” has cost the United States health care system $7.6 billion in lost savings since 2015.

*** Related Resources ***

[Video] What is Interchangeability?

[Patient Story] Biosimilars Gave Jeni Her Life Back

[Infographic] Biosimilars Benefit Everyone

[Report] 2020 Access & Savings Report


By increasing competition, biosimilars will improve patient access to some of the most vulnerable affected patient groups, including senior citizens and those with multiple chronic diseases. Listen to patients’ stories and learn how to make biosimilars more accessible.

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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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.