Biosimilars: Five Things IBD Patients Need to Know About New Medication Options

Drugs like Humira® (adalimumab) may help relieve Crohn’s disease, ulcerative colitis, and other chronic conditions, but they can easily cost thousands of dollars out of pocket. Less-expensive versions of these drugs, known as biosimilars, could be an option for many IBD patients. Humira’s patent expiration allowed for a flood of at least eight similar medications into the U.S. market this July. This is the highest number of biosimilars to launch in a single month.

While this development could mean more choices and lower costs for IBD patients, hurdles remain. A recent survey conducted by the Foundation found that nearly half of IBD patients feel concerned about switching to biosimilars. Additionally, insurance and pharmacy benefit management companies may limit consumer choices for these medications.

If you’ve been taking Humira or another biologic drug and have questions or concerns about these new options, here’s what you need to know.

1. What is a biosimilar?

If you are taking a biologic therapy, such as infliximab (Remicade®), or adalimumab (Humira®), to treat IBD, you may have heard about biosimilars.

Biologic therapies are complex proteins made in live cells that target part of your immune system. Biosimilars are near-identical copies of these approved therapies, sharing the same active ingredient and working the same as the original medication, also known as the reference drug. Biosimilars are just as safe and effective as the original biologic therapy, with no clinically meaningful differences.

Unlike generic medications, which are exact copies of original drugs, biosimilars can’t be identical to biologics due to the living material contained in biologics. However, biosimilars contain the same active ingredients as the reference drug. Biosimilars and biologics are administered directly, either through an intravenous infusion at a medical facility or through a shot at home. Biosimilars are taken in the same form and dose as the reference biologic medication.

2. Are biosimilars safe and effective?

“Every biosimilar is thoroughly tested and approved by the FDA, making them just as safe and effective as the biologics patients are already taking,” said Laura Wingate, Executive Vice President, Education, Support, & Advocacy, Crohn’s & Colitis Foundation. “Studies have shown that there are no clinically meaningful differences.”

3. Are there cost savings with biosimilars?

Insurance policies often dictate which medications are covered for IBD patients. The FDA’s streamlined approval process for biosimilars reduces manufacturing costs, aiming to broaden medication access. Currently, the cost-saving benefits of biosimilars largely go to insurance and pharmacy benefit management companies. The Foundation is advocating for these savings to be relayed to patients and their families through reduced co-pays and premiums. Support our advocacy for greater accessibility by joining our Advocacy Action Center network.

4. What should I ask my doctor if I receive notification from my insurance that I need to switch to a biosimilar?

If your insurance company prompts a medication switch, consider asking your insurance carrier and your healthcare professional the following questions:

• Why is my treatment changing?

• When will this change take effect?

• What can I expect with this change?

• Does this hospital/infusion center/medical group provide this treatment, or will I need to go to a different location?

• Will I be using an injectable product at home, and will someone instruct me on how to use it?

• What is the cost and will my share of cost change?

• Is co-pay assistance available?

• Who do I contact if I have questions about medication administration?

5. Where can I go for more information and support?

If you’re considering switching to a biosimilar, it’s crucial to weigh your options carefully and consult your doctor. We understand that you may have questions and concerns about these new drugs, and the Foundation is here to help. To access our biosimilars resources, please visit the Foundation’s dedicated page here. If you need further support, don’t hesitate to contact the IBD Help Center via email at [email protected] or by calling 1-888-MYGUTPAIN.

You can make an impact on IBD cures! Please consider making a donation to the Crohn’s & Colitis Foundation.