Biologics and Biosimilars: Expanding Treatment Options for People Living with IBD

Whether you currently take medication for inflammatory bowel disease (IBD) or you’re facing a recent diagnosis, you have several treatment options such as biologic therapies which are made with biological material and include biosimilars.

Biosimilars are medications that are designed to be near-identical, “highly-similar” copies of approved biological therapies (known as reference product or the original biologic). They have emerged as an alternative to more costly biologics in recent years. Biosimilars offer patients new treatment options at potentially a fraction of the cost, which is why physicians and insurance companies are starting to recommend them more frequently.

While some biosimilars are now available as options for treating IBD, people may have reservations about starting a biosimilar. Some are concerned that “similar” may not be good enough. Why take something similar when I can just take the original version of a drug? Do biosimilars even work as well as the original version? What if the biosimilar doesn’t work for me? 

If you find yourself asking these questions, you’re not alone. Before starting a biosimilar for her ulcerative colitis after her treatment stopped working, Laura also had concerns about biosimilars. “After talking with my doctor and learning about them, I started a biosimilar over four years ago. I’m now in my longest remission ever.”

We know making decisions about your IBD treatment can be challenging. You want a treatment that will help you live your best life. If you’re considering a biosimilar or your insurance is requiring you to switch from your original biologic (reference drug) to the biosimilar product for your IBD, we’ll help you understand what biosimilars are so you can make the most informed decision about your care.

What are biologics?

Biologics are therapies made using living, biological material (such as proteins) to treat disease. Vaccines, for example, are a type of biologic. By contrast, conventional medications (including pills we take, such as ibuprofen) are made with chemicals. Several biologic therapies exist to treat conditions like IBD, with the first biologic approved by the U.S. Food and Drug Administration (FDA) in 1998.

Biologics for IBD are most often made with antibodies from the human immune system that help the body fight the disease it was made for. Most therapies use antibodies to block the activity of TNF alpha (an anti-TNF therapy), a protein that controls inflammation in the body. People with IBD often produce too much TNF alpha, leading to inflammation and complications. 

What are biosimilars?

Biosimilars are also biologic therapies that are made with biological, living material. However, they replicate an existing biologic (called the reference drug). Biosimilars are designed to be the same as their reference drug in every meaningful way, including how they affect the body and how you can take them (i.e., IV infusion or injection). According to the FDA, “there are no clinically meaningful differences between [biosimilars] and the reference product [biologic] in terms of the safety, purity, and potency of the product.”

Biosimilars aren’t exact copies, however. Unlike conventional medications with known chemical structures, therapies that use living material are impossible to duplicate perfectly. Biosimilars are similar in every meaningful way, but they are not identical. For example, biosimilars may use different materials, called stabilizers and buffers, to protect and preserve the therapy before it is used.

Many major biologics for multiple different disease states have a biosimilar. Currently, the FDA has approved 10 biosimilars for treating IBD in the U.S., with biosimilars used to treat IBD seeing a roughly 42% rise in usage rates over the past six years. Many people switching from a biologic to a biosimilar start on the biosimilar that has the same mechanism of action (Anti-TNF) as their biologic.

Are biosimilars safe and effective?

Research shows that biosimilars are just as safe and effective compared to their reference drugs. When studying biosimilars, researchers often use “non-inferiority studies,” which compares two drugs to see if one is less effective, or inferior, to the other. One study comparing a common biologic and biosimilar for IBD found that the biosimilar was non-inferior. This meant there was no meaningful difference in the safety and effectiveness of the biosimilar compared to the biologic.

Several other studies have found that there is no meaningful difference in how people respond to biologics versus biosimilars, with patients taking biosimilars experiencing high rates of remission and like their reference product, patients experienced few or no side effects. Biosimilars have also been shown to have effective response rates in children similar to biologics.

Biosimilars go through rigorous testing before they can be used for treatment, just like a biologic. Regulatory agencies, such as the FDA, review data from animal and human clinical trials to make sure biosimilars meet their standards before approval. They also regulate how manufacturers produce biosimilars and biologics to ensure product quality.

“When I switched to the biosimilar, my doctor told me biosimilars work the same way as biologics. And insurance companies often prefer them.” However, Laura emphasized that her confidence in what she’d learned about biosimilars from her doctor made her feel confident in using a biosimilar.

How do I know if taking a biosimilar is right for me?

Biosimilars offer a more affordable yet equally effective treatment option for people with IBD compared to biologic reference products. Choosing a treatment option, however, is still a highly personal decision that should be made in collaboration with your healthcare team.

For Laura, advocating for herself with her doctor helped her feel confident she was making the right decision. “I was always prepared with questions for my doctor, even if the question was as simple as ‘why.’ Asking questions is a really great way to ease your mind and build confidence that you’re doing the right things for yourself. It worked for me.”

The Crohn’s & Colitis Foundation understands the importance of being well informed when making the best decisions regarding treatment for your IBD. You can find more information and additional resources about biosimilars on our Biosimilars: What You Should Know web page.


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