Biosimilars: What You Should Know

Biosimilars are biological therapies used to treat inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis. Similar to other biologic therapies, biosimilars are made from natural proteins to target part of your immune system.

Biosimilars are designed to be near-identical copies of approved biological therapies, which are called the reference product or the originator drug.

  • They are medications with the same effectiveness and safety as the originator product.

  • They are taken in the same form as the originator drug, such as by injection or intravenous infusion.

  • Biosimilars are approved by the Food and Drug Administration (FDA) to treat IBD.

Be Your Own Advocate

It is your right to be informed about your treatment options and to be involved in making decisions with your healthcare team.

It is important to research which medications are covered in your medical insurance plan. Several states have passed legislation to regulate the procedures that pharmacists must follow when substituting interchangeable biosimilars. These regulations vary state by state.

The Crohn's & Colitis Foundation supports the approach that patients and their doctors should work together when making decisions on what 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.

Tips for Researching Biosimilars

  • Visit the  National Conference of State Legislatures to look up the substitution laws in your state.

  • Talk to your pharmacist about decisions involving your medication.

  • Talk to your medical insurance company about your medication and any changes in your plan.

Biosimilar Terms to Know

When researching biosimilars or talking to your healthcare provider, you may hear certain terms used in describing biosimilars and originator biologic therapies. Here’s what you should know:

Switching

The term “switching” refers to your ability to go back and forth between an originator drug and a biosimilar, or even between two biosimilars, with no loss of effectiveness and no meaningful differences in treatment.

Interchangeability

“Interchangeability”refers to an FDA designation that deems a biosimilar interchangeable with the originator drug. This designation is made after thorough evaluation and testing, and it allows your pharmacist to substitute the biosimilar for the originator drug without the intervention of the healthcare provider.  At this time, none of the FDA approved IBD biosimilars have been approved by the FDA for interchangeability.

Biosimilars Resource Corner

The FDA has several resources on biosimilars. If you need more information, or can’t find what you are looking for, please reach out to our IBD Help Center.

Biosimilars Position Statement

Resource list

Biosimilar Position Statement...

Crohn's & Colitis Foundation's Biosimilar Position Statement