Biosimilars: What You Should Know
If you are taking a biologic therapy, such as infliximab (Remicade®), adalimumab (Humira®), vedolizumab (Entyvio®), or ustekinumab (Stelara®), to treat inflammatory bowel disease (IBD), you may have heard about, or are curious about, biosimilars.
Biologic therapies are complex proteins made in live cells that target part of your immune system.
Biosimilars are designed to be near identical copies of approved biologic therapies. Given the complexity of drug design, biosimilars cannot be exact copies of biologic therapies, but still contain the same active ingredient, mechanism of action (how they work), and dosing. Here are some key points to know and remember about biosimilars:
Biosimilars are just as safe and effective as the original biologic therapy. There are no clinically meaningful differences.
Biosimilars are taken in the same form (injection or intravenous) and dose as the related biologic medication (also known as the reference product).
Biosimilars are carefully reviewed and approved by the Food and Drug Administration (FDA) and are carefully monitored on an ongoing basis to treat IBD.
Biosimilars may be identified by the naming structure, in which the name of the reference product is listed, followed by a hyphen and four additional letters. For example, the biosimilars for infliximab include infliximab-dyyb (Inflectra®), infliximab-abda (Renflexis®), and infliximab-axxq (Avsola™).
To learn about all available biosimilars (including those not yet available in the US), visit the IBD Medication Guide.
To find the latest information regarding recently approved medications for IBD patients, please see Recently Approved Treatments.
Special biosimilar terminology
When researching biosimilars and/or talking to your healthcare provider, you may hear common terms used to describe biosimilars and biologic therapies. Here is what you should know:
- Reference product: This is the biologic product already approved by the FDA in which the biosimilar product is compared to. For example, the reference product may be infliximab or adalimumab.
- Switching: Switching refers to changing between a reference product and a biosimilar, or between biosimilars, with no loss of effectiveness and no meaningful differences in treatment or safety.
- Interchangeability: Interchangeability is designated by the FDA and means the biosimilar is considered interchangeable with the reference product. Medications provided this designation allow for pharmacists to substitute the biosimilar for the reference product when ordered without requiring any action from the clinician. At this time, only one FDA approved biosimilar is approved for interchangeability, but it is not yet available in the U.S market.
Frequently asked questions
Be Your Own biosimilar advocate
You have the right to know about your available treatment options and to be involved in making decisions with your healthcare team.
The Crohn's & Colitis Foundation believes that patients and their doctors should work together when deciding which treatment to choose, and that no decision should be made by a pharmacist or medical insurance company without the consent of the patient and doctor.
Resources on biosimilars
Visit the Foundation’s resources about IBD, medications, and insurance information:
- The Crohn's & Colitis Foundation's Biosimilars Position Statement
- Medications webpage: Crohn's and ulcerative colitis
- Biologics Factsheet
- What to do if you are denied coverage
The FDA has several resources on biosimilars.
- Biosimilars and Interchangeable Products
If you need more information, or can’t find what you are looking for, please reach out to the Crohn’s & Colitis Foundation’s IBD Help Center.
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