Crohn's Disease
9 Biologics for Crohn’s Disease: Why Remicade, Stelara, and More Can Make a Difference
Biologics are first-choice treatment options for moderate-to-severe Crohn’s disease. Nine biologics are currently FDA approved to treat it.
Humira (adalimumab), Remicade (infliximab), and Stelara (ustekinumab) are a few examples of biologics that manage moderate-to-severe Crohn’s disease. The best biologic for you depends on factors such as your age, personal preferences, and health background.
Specific side effects vary by medication. But injection site pain, headache, and fever are a few examples of common biologic side effects.
Crohn’s disease is an autoimmune disorder that causes inflammation in the gastrointestinal (GI) tract. This often causes uncomfortable GI symptoms, such as stomach pain and diarrhea. In more severe cases, the GI tract gets damaged.
Although there isn’t a cure for Crohn’s disease, there are medications — such as biologics — that can help manage symptoms and address underlying inflammation. Biologics are complex medications that work by calming down an overactive immune system. They’re considered first-choice treatment options for moderate-to-severe Crohn’s disease. Research shows they can help you become symptom-free (reach remission) sooner, especially if they’re started early.
Knowing more about nine biologics for Crohn’s disease can help you decide if one is right for you or a loved one.
Humira (adalimumab) is FDA approved to manage moderate-to-severe Crohn’s disease in adults and kids ages 6 years and older. It lessens inflammation by blocking an immune system protein called tumor necrosis factor (TNF).
You can administer Humira to yourself, which isn’t always the case with biologics. Humira comes as an injection that’s administered into the fat under the skin (subcutaneously) every other week. Your pharmacist or prescriber can show you how to give yourself a Humira injection.
Humira’s design is effective for many people. The American Gastroenterological Association (AGA) recommends it as a go-to medication for moderate-to-severe Crohn’s disease. One large study found that Humira was effective for at least 6 years.
Good to know: Humira should typically be refrigerated. But if you’re traveling, you can store Humira at room temperature for up to 14 days (2 weeks) in its original carton.
Like generic versions of brand-name medications, biosimilars help make biologic medications more affordable and accessible. They’re very similar to their original (reference) biologic medication in terms of safety and effectiveness.
These are ten approved Humira biosimilars:
Amjevita (adalimumab-atto)
Cyltezo (adalimumab-adbm)
Hyrimoz (adalimumab-adaz)
Hadlima (adalimumab-bwwd)
Abrilada (adalimumab-afzb)
Hulio (adalimumab-fkjp)
Yusimry (adalimumab-aqvh)
Idacio (adalimumab-aacf)
Yuflyma (adalimumab-aaty)
Simlandi (adalimumab-ryvk)
Oral medications for Crohn’s disease: Pharmacists walk through Crohn’s disease medications you can take by mouth, from aminosalicylates and corticosteroids to immunomodulators.
Tired of infusions? If you’re receiving Remicade (infliximab) but you’re looking for a more convenient option, ask your prescriber about Zymfentra (infliximab-dyyb), an under-the-skin injection.
Crohn’s meal plan tips: Find out what one woman eats to manage her symptoms of this inflammatory bowel disease.
In 1998, Remicade (infliximab) became the first biologic approved for Crohn’s disease. It shares several similarities with Humira. It’s a TNF blocker that treats moderate-to-severe Crohn’s disease in adults and kids ages 6 years and older. And it’s a first-choice treatment option.
One of the key differences between Remicade and Humira is that Remicade is given as an intravenous (IV) infusion in a medical setting. You can’t inject it at home. Typically, you’ll start off with 3 “loading” infusions spread out over 6 weeks. After that, you’ll usually receive it once every 8 weeks (2 months) for maintenance treatment.
Research shows that Remicade is effective at helping people with Crohn’s disease reach remission.
Good to know: Each Remicade infusion takes about 1 to 2 hours to receive. If you have a hectic daily schedule, make sure to take this into account.
Humira isn’t the only Crohn’s biologic with biosimilars available. Check out the four approved Remicade biosimilars:
Inflectra (infliximab-dyyb)
Renflexis (infliximab-abda)
Avsola (infliximab-axxq)
Ixifi (infliximab-qbtx)
Ixifi likely won't be available in American clinics and infusion centers. It's produced by the same company that manufactures Inflectra.
Good to know: Zymfentra (infliximab-dyyb) is another option to consider. It’s an under-the-skin, injectable version of infliximab that was modeled after Inflectra. It’s not technically a biosimilar, though, because of how it’s administered.
Cimzia (certolizumab pegol) is another TNF blocker. It’s approved to manage moderate-to-severe Crohn’s disease in adults specifically.
Cimzia comes as an under-the-skin injection that’s initially given every 2 weeks. If the medication ends up working for you, you’ll give yourself an injection every 4 weeks (1 month) as maintenance treatment. You can conveniently self administer this medication at home. Talk to your pharmacist or prescriber before starting treatment with Cimzia to make sure you have the technique down.
Cimzia likely won’t be the first biologic you try for Crohn’s disease. The AGA generally recommends other biologics — like Humira — over Cimzia. This is because Cimzia may not be as effective as some other biologics at helping people reach remission.
Entyvio (vedolizumab) behaves differently than Humira, Remicade, and Cimzia. It’s an integrin receptor blocker. It blocks certain immune cells from entering the GI tract and causing inflammation in Crohn’s disease.
Entyvio is first administered as an IV infusion. After two initial doses given 2 weeks apart, you may choose to continue receiving Entyvio by IV infusion or switch to an under-the-skin version.
If you continue receiving the IV infusion, you'll get a dose 4 weeks later, then every 8 weeks. If you switch to the under-the-skin injection, you may give yourself a dose every 2 weeks.
The AGA recommends Entyvio as a treatment option for adults with moderate-to-severe Crohn’s disease. One large review found that Entyvio is effective for helping people with Crohn’s disease reach remission — and helping them stay there. Your prescriber can help you decide if and when Entyvio would be the next step in your treatment plan.
Good to know: If your symptoms aren’t improving after 14 weeks (3 to 4 months), talk with your prescriber about switching to a different biologic. In some cases, Entyvio is given more often than every 8 weeks to better control symptoms, but this approach isn’t FDA approved.
Tysabri (natalizumab) is another integrin receptor blocker for moderate-to-severe Crohn’s disease in adults. It’s given as an IV infusion every 4 weeks. Each infusion takes about 1 hour to finish.
Research shows Tysabri is effective for managing Crohn’s disease. But it carries the risk of a serious brain infection called progressive multifocal leukoencephalopathy (PML). For this reason, Tysabri is only available through a restricted program called the TOUCH Prescribing Program.
Tysabri typically isn’t recommended for Crohn’s disease because of this risk. But it may be an option if you can’t receive other biologics.
In August 2023, the FDA approved the first Tysabri biosimilar, known as Tyruko (natalizumab-sztn). It can treat Crohn’s disease and multiple sclerosis.
Skyrizi (risankizumab) lowers inflammation by blocking a protein called interleukin-23 (IL-23). It’s dubbed an “IL-23 blocker.”
Skyrizi is another approved treatment for moderate-to-severe Crohn’s disease in adults. But its dosages are unique. Three starter doses are administered as an IV infusion. After this, you can administer Skyrizi at home, as an under-the-skin injection, every 8 weeks.
Two phase 3 trials showed Skyrizi was effective for managing Crohn’s disease. The medication isn’t officially included in clinical guidelines yet, but your prescriber may recommend Skyrizi if TNF blockers like Humira don’t work for your symptoms.
Stelara (ustekinumab) is similar to Skyrizi. It blocks IL-23, but it also blocks a protein called IL-12. Stelara helps lower inflammation by interfering with both of these inflammatory proteins.
The AGA recommends Stelara as a possible first-choice biologic for moderate-to-severe Crohn’s disease in adults. If your prescriber recommends Stelara, you’ll likely start with an IV infusion for your first dose. After this one-time infusion, you can administer Stelara at home as an under-the-skin injection every 8 weeks.
You should store your Stelara injections in the refrigerator when possible, but one injection can be left at room temperature for up to 30 days in the original carton. The manufacturer says you shouldn’t put a dose back in the refrigerator after it’s been stored at room temperature.
The FDA approved Wezlana (ustekinumab-auub), the first Stelara biosimilar, in October 2023. It’s considered to be interchangeable with Stelara: The two are used the same way and are approved to treat the same health conditions, including Crohn’s disease. It launched commercially in January 2025.
Other Stelara biosimilars include:
Selarsdi (ustekinumab-aekn)
Pyzchiva (ustekinumab-ttwe)
Otulfi (ustekinumab-aauz)
Imuldosa (ustekinumab-srlf)
Yesintek (ustekinumab-kfce)
Steqeyma (ustekinumab-stba)
Omvoh (mirikizumab-mrkz) is another newer biologic. Like Skyrizi, it’s an IL-23 blocker, and it’s approved to treat moderate-to-severe Crohn’s disease in adults.
Treatment with Omvoh typically starts with three IV infusions given over the course of 8 weeks. After that, you’ll switch to a monthly under-the-skin injection that can be given at home. Each dose helps reduce inflammation in the digestive tract and may lead to long-term symptom control.
While Omvoh is one of the newer biologics on the market, studies show that it’s effective for helping people reach and stay in remission. A head-to-head study also showed that Omvoh helped reduce tissue-related inflammation more than Stelara.
Omvoh isn’t yet listed in official Crohn’s disease treatment guidelines. But your prescriber may recommend it — especially if other biologics haven’t worked for you.
Tremfya (guselkumab) is another IL-23 blocker that’s approved to treat moderate-to-severe Crohn’s disease in adults.
Like many other biologics, Tremfya is given in two stages:
Induction doses: There are two ways to get started with Tremfya. One option is receiving 3 IV infusions, each spaced apart by 4 weeks. The other option is getting under-the-skin injections over the same timeframe. Tremfya is the only IL-23 inhibitor that offers this flexibility with induction doses.
Maintenance doses: You’ll inject an under-the-skin injection every 4 to 8 weeks, depending on your response to the medication. These injections can be administered at home.
In clinical studies, people treated with Tremfya were more likely to experience significant clinical remission compared to those who received a placebo. Tremfya also outperformed results from Stelara.
Like Omvoh, Tremfya is one of the newest Crohn’s biologics and is still being integrated into treatment guidelines.
Like all medications, biologics can cause side effects. Specific side effects vary by medication. But common ones include:
Injection site pain, swelling, and redness
Headache
Fever
Chills
Rash
Infusion reactions can also happen when receiving an IV biologic. They can happen during or after your infusion. You’ll be monitored closely for signs of a reaction during your clinic visit. Let your prescriber know if you experience swelling, redness, or itching after you leave.
Biologics for Crohn’s disease can weaken your immune system, making it harder to fight off infections. Before starting a biologic, your prescriber will likely test you to make sure your risk from an infection like tuberculosis (TB) or hepatitis B is low.
Other issues are also possible, albeit rare. Check out the table below for some examples of rare but serious side effects that have been reported with Crohn’s disease biologics.
Biologic | Serious side effect |
|---|---|
Humira | Lymphoma, drug-induced lupus |
Remicade | Heart problems, lymphoma, liver damage |
Cimzia | Lymphoma |
Entyvio | Liver damage, pancreas inflammation |
Tysabri | PML, liver damage, bleeding risk |
Skyrizi | |
Stelara | Posterior reversible encephalopathy syndrome (a brain condition) |
Omvoh | Liver damage |
Tremfya | Liver damage |
Reach out to your prescriber about any new or worsening symptoms — including a fever, cough, or skin infection — while you’re receiving a biologic.
The best biologic for you boils down to a variety of different factors, such as age, health conditions, and personal preferences. The specific symptoms you’re experiencing, alongside your insurance plan’s formulary, can also play big roles.
For instance, if your 6-year-old child needs a biologic, Humira and Remicade could be options. Or, if you’re living with heart failure, Remicade may not be the best option because it can make your symptoms worse. And if you’re looking for a convenient, at home option, Humira or Cimzia could be ideal choices.
Nine biologics are currently FDA approved to manage moderate-to-severe Crohn’s disease. They’re administered by an IV infusion or under-the-skin injection. Humira (adalimumab), Remicade (infliximab), and Stelara (ustekinumab) are examples of first-choice treatments for managing Crohn’s disease. Talk with your prescriber about which biologic is right for you.
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