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

What Are Biosimilars?

Are Biosimilars Safe?

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.”

Is it safe to switch from a reference biologic to a biosimilar?

Yes. A number of studies have looked at the safety of switching from a reference biologic to its biosimilar and from a biosimilar to its reference biologic, and they have found it to be safe. A review and meta-analysis of these studies, published in October 2023 in PLOS One, looked at more than 5,200 patients who had switched between a reference biologic and its biosimilar. It found that there was no meaningful difference in the risks of serious side effects or deaths between those who switched and those who didn’t. It also found that patients who switched between biologic and biosimilar had the same immune response as those who didn’t switch, so both medications were as effective and both had similar immune-related side effects, such as injection site and hypersensitivity reactions. Read the study.

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.

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New Kinds of Biologics

If you take a biologic drug to manage your arthritis, you’ll probably be hearing more about “biosimilars.” Download our e-book to learn what these drugs are and how they compare with brand-name biologics.

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Biosimilars at a Glance

If you take, or think you might take, a biologic drug for your arthritis, you should know about biosimilars. Check this quick reference chart for new Humira biosimilars.

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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.

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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.

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As biosimilars become increasingly available, specialty pharmacies, health plans and providers are in a powerful position to influence patient attitudes and experiences. Please find specific insights from the Arthritis Foundation survey and focus group findings to help guide you in your communications plan with patients.

Recommendations for Specialty Pharmacies Recommendations for Health Plans Recommendations for Providers

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

Live Yes! With Arthritis Podcast

Biosimilars: What to Expect

If you take a biologic drug to manage your arthritis, you might be facing some unexpected decisions as more competitors to brand-name biologics — called biosimilars — become available in the U.S. This year, at least eight biosimilars to the self-injectable biologic Humira are coming to market. Learn more about these drugs and what questions to ask your doctor and insurance company.

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Live Yes! With Arthritis Podcast

Biosimilars 101 & Inflammatory Arthritis

Access will soon expand for new biologic treatments for inflammatory arthritis called biosimilars. Learn what they are, what to expect when taking one, including safety and effectiveness, and how determine if they are right for you.

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