Biosimilars- What IBD Patients Should Know


What Are Biosimilars?

Biosimilars are biological therapies, proteins that have been made to target part of the immune system. Biosimilars are designed to be similar, near identical copies of other already approved biological therapies also known as the reference product or originator biologic. They are drugs that act just like the originator product, having the same effectiveness and safety in the patient population that it treats. Biosimilars are also taken in the same form as the originator product (example, by injection or intravenous infusion). The Food and Drug Administration (FDA) has approved biosimilars for the treatment of inflammatory bowel diseases (IBD) including Crohn's disease and ulcerative colitis. When considering any treatment option, be sure to talk to your doctor about potential risks and benefits. 

Switching 

The term switching refers to the ability to receive treatment back-and-forth between an originator drug and a biosimilar, or even between two biosimilars, with no loss of effectiveness, and no clinically meaningful differences. 


Interchangeability

The team interchangeable refers to an FDA designation where a biosimilar is deemed to be interchangeable with the reference/originator product through additional evaluation and testing. Interchangeability allows the pharmacist to substitute the biosimilar for the reference/originator drug without the intervention of the healthcare provider.   At this time, there are no interchangeable biosimilars approved by the FDA. 

Be your own advocate!

You have the right to be informed, voice concerns about your health, and be involved in decision-making with your healthcare team. With biosimilars entering the U.S. market, it is important for you to pay close mind to what 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. The regulations for substitution 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 your consent of the patient and doctor. Some tips to keep in mind include:

  • Know the substitution laws in your state visit: National Conference of State Legislatures
  • Work with your doctor to find an IBD treatment plan that works best for you
  • Talk to your pharmacist about decisions around your medication
  • Talk to your medical insurance company about your medication and any changes in your plan. 

Biosimilars Resource Corner

To learn more about biosmilars, click and view the resources below:

Biosimilars information -- FDA

Biosimilars: More Treatement Choices and Innovation- FDA

Biosimilars and interchangeable products- FDA

Crohn's & Colitis Foundation - Biosimilars Position Statement                      



For further information, call Crohn's & Colitis Foundation's IBD Help Center: 888.MY.GUT.PAIN (888.694.8872).

The Crohn's & Colitis Foundation provides information for educational purposes only. We encourage you to review this educational material with your health care professional. The Foundation does not provide medical or other health care opinions or services. The inclusion of another organization's resources or referral to another organization does not represent an endorsement of a particular individual, group, company or product.

About this resource


Published: January 19, 2017

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