A doctor or healthcare professional may prescribe medications called biologics to treat inflammatory bowel diseases (IBD) such as Crohn’s disease and ulcerative colitis. These medications have helped those with moderate and severe IBD experience disease remission and a better quality of life. But these medications can also be very expensive.
Enter biosimilar medications. These medications are near copies of biologic medications with (typically) a much lower price tag. It’s easy to wonder if less expensive means they’re less effective. Let’s dig into the connections between biosimilars and IBD treatment.
Biosimilars are drugs manufactured to be almost exactly like biologic drugs. They’re the same in key areas: active ingredients, how they work, and how they’re dosed.
The Food and Drug Administration (FDA) must also review and approve biosimilar drugs for safety and efficacy.
Pharmaceutical manufacturers make biosimilar drugs to treat a number of health conditions, including psoriatic arthritis and cancers.
Why do we need biosimilar medications?
When drug manufacturers research a drug, they may file for a patent for the medication. A patent prevents other drug manufacturers from making the same drug. But patents don’t last forever (usually, for medications, it’s about 20 years).
When patents do expire, other companies can make medications that are “copies” of the originals. Biosimilars are these less expensive copies of medications. In the pharmaceutical world, the original biologic drug is called the “reference product” and biosimilars are the medications that follow.
If this sounds like a generic medication to you, you wouldn’t be the only person who’s wondered this. But the nature of biologic medications means that biosimilars aren’t the same as generics.
Biologic medications are highly complex. Pharmaceutical manufacturers make them inside living cells, and they’re incredibly intricate. The process is so technical, it’s virtually impossible for the biosimilar to be an exact copy of the biologic drug — but they can achieve the same results.
Biologic drugs are medications doctors prescribe to treat IBD. These include:
- adalimumab (Humira)
- infliximab (Remicade)
- ustekinumab (Stelara)
You can usually identify their counterpart biosimilar drugs by their names. They’ll begin with the same name, plus a dash and several letters after them. The FDA has approved these biosimilars for IBD treatment in the United States, including these that are based on Remicade:
- infliximab-dyyb (Inflectra)
- infliximab-axxq (Avsola)
- infliximab-abda (Renflexis)
What is the difference between biosimilar and generic drugs?
If you compared biologic drugs with their biosimilars molecule to molecule, they would likely have slight differences. While they’re chemically identical in the way that generic drugs are, if you take biosimilars, they’re required by the FDA to work the same as the original biologic drug.
Coverage for biosimilars and biologic medications can vary by insurance policy. It’s not uncommon to be receiving a biologic medication and receive a notification from your insurance company that they’re switching you to a biosimilar.
Medicare Part D (prescription drug coverage) most commonly covers biologics and biosimilars. Part D plans spend an estimated $12 billion annually on biologic medications for many diagnoses, including IBD.
Humira, a biologic used to treat IBD and other inflammatory medical conditions, is the “bestselling” prescription drug worldwide. Doctors prescribe it five times the rate of its available biosimilars, according to the U.S. Department of Health and Human Services (HHS). But biosimilars aren’t always on Part D medication listings.
Adding these biosimilars can potentially cut costs for Medicare and private insurance enrollees. Over time, the HHS projects that more insurance companies will add these medications to their formularies.
Treatments for IBD depend upon your condition itself, how severe your disease is, and your overall health. Biologics aren’t usually a first-line treatment for IBD. Doctors will
- 5-aminosalicylic acid, such as mesalamine
- immunomodulators, such as azathioprine or methotrexate
But if this medication combination doesn’t treat your condition or you have extensive, active disease,
These medications don’t work for every person with IBD. If your biologics stop working or don’t work well, a doctor may switch you to another drug type, increase your dose, or prescribe medications called immunomodulators that can try to keep your body from rejecting the medication.
As more biologic drug patents expire, more biosimilars will hit the market. The FDA will likely approve more biosimilars, so if you have IBD, you may see these medications more and more. To gain this approval, the biosimilar drug must prove not only its safety but also that it produces the same results as the original.
If a doctor prescribes a biosimilar medication (or your insurance company substitutes it), the biosimilar will work just as well as your biologic medication.