Stelara Goes Biosimilar: What Biologic Coordinators Need to Know This July

Stelara Goes Biosimilar: What Biologic Coordinators Need to Know This July

By Brianna Pepin

Biosimilar transitions are nothing new—but this July, a big name is joining the biosimilar landscape: Stelara (ustekinumab). For biologic coordinators working in dermatology, gastroenterology, and rheumatology, the launch of Stelara biosimilars marks a significant change in treatment access, coverage, and patient support.

If you’ve navigated the Humira biosimilar wave, you already know: transitions like this can come with payer mandates, specialty pharmacy changes, and patient confusion. In this blog, we’ll break down what’s happening with Stelara, which biosimilars are launching, and how to prepare for the shift.

What’s Stelara, and Why Is This a Big Deal?

Stelara (ustekinumab) is a monoclonal antibody that targets IL-12 and IL-23, used to treat:

• Moderate to severe plaque psoriasis

• Psoriatic arthritis

• Crohn’s disease

• Ulcerative colitis

It’s a high-cost, high-impact medication, and for years, it’s been brand-only with tight manufacturer control. But as of July 2025, the first biosimilars to Stelara will begin launching in the U.S., introducing competition—and likely payer-preferred product shifts.

What Biosimilars Are Launching?

Here are the biosimilars currently announced or approved to launch starting July 2025:

Selarsdi (ustekinumab-aekn)
Manufacturer: Amgen
FDA Approval: Approved
Launch Date: July 1, 2025
Indications: Same as reference Stelara
Expected Payer Role: Could be preferred for select commercial and Medicare plans

Wezlana (ustekinumab-auub)
Manufacturer: Samsung Bioepis / Organon
FDA Approval: Approved
Launch Date: Mid-to-late July 2025
Indications: Psoriasis and psoriatic arthritis initially; others pending

More biosimilars are in development and expected to follow through 2025–2026. As with Humira, the competitive market will likely drive PBM deals and rapid formulary changes.

Other Stelara Biosimilars to Watch

While Selarsdi and Wezlana are the first two biosimilars launching in July 2025, several others are in development or awaiting FDA approval. These may launch later in 2025 or early 2026 depending on regulatory timelines and exclusivity agreements.

Here’s a list of additional Stelara biosimilars to keep an eye on:

⚠️Note: FDA naming conventions for biosimilars may assign suffixes closer to approval (e.g., ustekinumab-xyz). Keep an eye on updated naming once products are approved. 

✏️ How to Use This Information as a Biologic Coordinator 

Start a biosimilar watchlist in your EMR or shared drive to track biosimilar launches and payer preferences. 

Keep manufacturer contact numbers and copay site links handy for each new biosimilar (we can help you build that table if needed). Train new team members on how biosimilars affect PA submission, NDC selection, and refill coordination. 

 📋 What This Means for Biologic Coordinators If you manage patients on Stelara, here’s what to anticipate:

 ✅ Payer Mandates Many insurers will begin preferring biosimilars over Stelara—especially for treatment-naïve patients. Some may even require switching current patients, though this will vary by plan.

 ✅ Specialty Pharmacy Shifts You may see changes in the designated specialty pharmacy depending on the biosimilar manufacturer and PBM contracts.

 ✅ Prior Authorization Changes Plans may begin requiring new PAs, different J-codes or NDCs, or may reject Stelara claims in favor of the preferred biosimilar.

 ✅ Copay & Support Program Updates Each biosimilar manufacturer will have its own copay card, bridge program, and patient support services. This means extra education for patients and coordination for your team.  

🧠 Tips for Navigating the Stelara Biosimilar Shift 

Create a Stelara Transition Tracker: Keep notes on which insurers are shifting, which biosimilars they prefer, and which pharmacies are filling them. 

Pre-check insurance benefits for all Stelara renewals in July and beyond Educate providers early—let them know patients may be switched and that support services will vary 

Re-enroll patients in copay programs as needed; don’t assume Stelara support covers biosimilars 

Watch the NDC and HCPCS codes—ensure the biosimilar is properly documented for both billing and tracking  

💬 What to Say to Patients 

Patients stable on Stelara may feel anxious about a switch. Offer reassurance: “This is a biosimilar, meaning it works the same way as your current medication.” “Your insurance now prefers this version, but we’ll make sure the transition is smooth.” “We’re working closely with your provider, the pharmacy, and the manufacturer to prevent delays.” 

 🔚 Final Thoughts: Be Ready for July 

The Stelara biosimilar launch isn’t just a policy change—it’s a workflow shift for anyone managing specialty medications. By staying informed and organized, you can guide patients through the transition confidently and minimize treatment interruptions. We’ll continue to monitor payer policies, new biosimilar launches, and specialty pharmacy guidance. If you have updates in your region, share them with your coordinator community—it helps us all stay a step ahead.  

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At BC Educators, we are dedicated to empowering biologic coordinators, healthcare professionals, and patient advocates with the education, tools, and resources needed to optimize patient care. From expert-led webinars to hands-on training, we provide comprehensive support to help you navigate the ever-evolving landscape of specialty medications and prior authorizations.

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