Latest approved Stelara alternatives for Crohn's disease [2024]

Crohn's disease is a life-long condition and, so far, there is no cure. However, there are multiple treatments available to help manage the disease. And while these may work well on many patients, no single treatment works for everyone. That's why you and your doctor may need to try different approaches until you identify what works for you.

When Stelara (ustekinumab) was first FDA approved in 2009, it was a medicine with a novel approach. Namely, it was the only one to target the IL-12 and IL-23 proteins associated with gastrointestinal inflammation.

If the medicine has worked for you, that's great! However, if you're in need of Stelara alternatives, here are the latest approvals to discuss with your treating doctor.

Why a Stelara alternative may be necessary

Stelara can be an effective treatment for Crohn's disease. 40% of patients in a recent study reported being in remission 12 months after starting the treatment ¹.

However, this doesn't guarantee that Stelara will be effective for you. And even if it is, there can still be several reasons to consider alternatives to Stelara for your Crohn's disease. For example:

• Side effects. Though rare, Stelara may cause serious side effects. These include serious infections (such as tuberculosis), pneumonia, lung swelling, allergic reactions, cancer (such as skin cancer), and posterior reversible encephalopathy syndrome (a brain condition) ².
• Medicine interactions. Stelara interacts with some other medicines, including warfarin, cyclosporine, allergy shots, JAK inhibitors, and other biologic immunomodulators. If you're already taking these medicines, Stelara may not be a suitable choice for your treatment ³.
• Your preferences. You may be seeking Stelara alternatives due to your own personal preferences. For example, because you'd prefer a different mode of administration or a different treatment regimen that fits your lifestyle better.
• Price. Medicine prices can differ greatly between brands and countries. Local reimbursement can also differ depending on the medicine you use. Sometimes, an interchangeable medicine can give you the same results while lowering your costs.

Whatever your reasons may be for seeking other treatment options for your Crohn's disease, you have multiple alternatives to consider.

Latest approved Stelara alternatives for Crohn's disease

Since 2022, multiple treatments for Crohn's disease have been approved. Below is a (non-exhaustive) list that will help you and your doctor discuss next steps for your treatment.

Skyrizi

Skyrizi (risankizumab-rzaa) is an interleukin-23 inhibitor indicated for the treatment of moderate to severe Crohn's disease in adults. It works by specifically targeting the interleukin-23 (IL-23) protein, which is one of the key proteins responsible for inflammation. In this way, Skyrizi aims to reduce the excess inflammation that can contribute to Crohn’s symptoms ⁴.

• Skyrizi vs Stelara

There is one main difference between the two medicines - the way they work. Both Skyrizi and Stelara inhibit interleukin proteins. However, Stelara targets both IL-12 and IL-23, while Skyrizi only targets IL-23.

For more details, deepdive into the differences between Skyrizi and Stelara.

Wezlana

Wezlana (ustekinumab-auub) is an IL-12 and IL-23 antagonist indicated for the treatment of adults with moderate to severe Crohn's disease ⁵. As an interchangeable Stelara biosimilar medicine, it works in a similar way and can be used for the same indications. Both medicines are approved in the USA and EU. However, in the EU, Wezlana is marketed under the name Wezenla.

• Wezlana vs Stelara

  The only notable difference between these two interchangeable medicines is the price. Wezlana is expected to have a lower price than Stelara ⁵. While this may not matter if your insurance covers both treatments, for patients paying out of pocket, this can make a big difference.

  For more details, see the full comparison between Wezlana and Stelara.

   

Steqeyma

Steqeyma (ustekinumab) is another interchangeable biosimilar to Stelara. It's also an IL-12 and IL-23 inhibitor and is indicated for treating adult patients with moderately to severely active Crohn’s disease who have not responded to, have stopped responding to, or are not eligible for conventional therapy or a TNFα antagonist ⁶.

• Steqeyma vs Stelara

  The two medicines are very similar, with the main difference currently being in the countries where they are approved. As of July 2024, Steqeyma is only approved by the EMA in Europe and in Korea. Its FDA approval application is still pending ⁶.

Pyzchiva

Pyzchiva (ustekinumab-ttwe) is the latest approved interchangeable biosimilar to Stelara, meaning that it has the same active ingredient and a comparable efficacy and safety profile.

• Pyzchiva vs Stelara

  Like Wezlana, Pyzchiva also mainly differs from Stelara in the expected lower price. As Pyzchiva’s approval is still very recent, there is no specific price indication available yet, but it may be worth keeping an eye on if treatment costs are a factor for you ⁷.

What if the Stelara alternative you need isn't available in your country (yet)?

As new Crohn's disease treatments are developed, approval and availability can take years in some countries. However, waiting is not your only option. If a treatment is already approved somewhere in the world, you can already access it now. This also applies if the treatment is approved in your country, but not yet available.

This is possible thanks to the Named Patient Import regulation in effect in most countries.

Is one of the latest Stelara alternatives not (yet) approved in your country? We can help you access it legally if you have a prescription from your doctor. Contact us to find out more.

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References:

1. Taylor, Marygrace. Stelara for Crohn's: How Does It Work, Side Effects and More. HealthCentral, 3 June 2024.
2. Learn About STELARA® (ustekinumab) for Crohn's Disease. Stelara, Accessed 23 July 2024.
3. Weiser, Patricia. Stelara Interactions: Other Medications, Alcohol, and More. Healthline, 15 April 2024.
4. Reference ID: 5000374. Accessdata.fda.gov, Accessed 23 July 2024.
5. HIGHLIGHTS OF PRESCRIBING INFORMATION. Accessdata.fda.gov, Accessed 23 July 2024.
6. Steqeyma | European Medicines Agency. European Medicines Agency, 28 June 2024.
7. Pope, Carmen. Pyzchiva: Uses, Dosage, Side Effects, Warnings. Drugs.com, 3 July 2024.