Biologics & Biosimilars

More biologic medications will become available soon in the U.S., creating options and access to more people. These “biosimilars” have been shown to be as effective and safe as existing biologics. Learn about the similarities and differences between biologics, unbranded biologics and new biosimilars.

"I think people should try to be reassured that these drugs are high quality. They are highly similar. The likelihood of them not doing exactly the same thing is infinitesimally low."

Mark Box, MD

Biosimilars FAQs

What is a biosimilar?

A biosimilar is a type of biologic — a disease-modifying antirheumatic drug (DMARD) — that helps slow or stop the over-active inflammation that drives diseases like rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and other autoimmune inflammatory forms of arthritis.
 

How is a biosimilar different from other biologics?

Original, or “reference,” biologics are name-brand drugs that have been on the market since the late 1990s. The Food and Drug Administration (FDA) requires that biosimilars have no “clinically meaningful differences” from reference biologics, meaning that they are required to be as safe and effective as their reference product.
 

Are biosimilars generic drugs?

They are not the same as generic drugs, which are copies of drugs with specific chemical formulas. Biologics, including biosimilars, are made from proteins and other living organisms, which are unique and complex and cannot be copied exactly. However, biosimilars are made in the same ways as their reference product and are as safe and effective.
 

Will biosimilars cost less?

They are intended to be less expensive and to pose competition to brand-name biologics, which would ideally drive down costs. Whether you will pay less out of pocket depends on your insurance plan.
 

What is an unbranded biologic?

Unbranded biologics are the same as name-brand, reference biologics, but without the labeling and branding. They may cost less, but it isn’t clear whether and how they might be substituted for the name-brand drug. The FDA regards them as “equivalent.”
10 Things to Know
Get the basics about biologics, unbranded biologics, biosimilars and what you should know about them from our downloadable fact sheet.
Get the Facts
Questions for Your Doctor
These questions will help you discuss biosimilars with your doctor. Print it and take it on your next visit.
Explore Now
Our Position
The Arthritis Foundation continues to keep patient welfare and education at the forefront of discussions and decisions about biosimilars. Learn about your rights and responsibilities as a patient, doctor, policymaker or other stakeholder.
Learn More
Biologics Basics
Biosimilars are a subset of biologic drugs, which many people use to control their autoimmune inflammatory arthritis. Learn about biologics and what “unbranded biologics” are.
Learn More
Biosimilars Webinar

A rheumatologist discusses biosimilars, insurance coverage and out-of-pocket costs. He also explains “interchangeability” laws and how they might affect you if you currently take or might take biologic medications.

"We’ve been using medications that were biosimilars in the U.S. but it was … given in the infusion center as an IV. In 2023, the first patient-administered biosimilar will be available."

Angus B. Worthing, MD
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