FDA Approval of Interchangeability Status of Stelara Biosimilar, Otulfi: What it Means for SmithRx Clients

This month marks a big step forward for access, transparency, and affordable care. In a major win for patient access, pharmacy benefit transparency, and affordability, the FDA has granted interchangeability status to Otulfi—a biosimilar to Stelara (ustekinumab). This milestone unlocks even greater savings for SmithRx clients and further simplifies the transition to lower-cost therapies for members managing autoimmune conditions.

The FDA’s biosimilar approval process was designed to encourage competition and innovation—offering lower prices and greater choice for patients. Since biologics are among the most expensive drugs on the market, driving competition is essential to expanding access and lowering healthcare costs across the board.

At SmithRx, we’ve long believed that biosimilars are key to reducing runaway specialty drug costs. That’s why we acted quickly earlier this year to introduce Stelara biosimilars into our Connect 360 Autoimmune Program, projecting over $14.5 million in savings for participating clients (up to $155,000 per person) in avoided costs.

Just two months after launch, the program has already delivered ~$1.9 million in savings—proof that proactive biosimilar strategies can drive meaningful impact fast.

Why Interchangeability Matters

Biosimilars are already proven to be highly clinically similar in terms of safety and efficacy compared to their brand-name counterparts. Interchangeability takes it a step further by allowing pharmacists to substitute Otulfi for Stelara without requiring a new prescription from the prescriber in most states. For health plans and members, that means:

• Faster member transitions to lower-cost alternatives
  
• Fewer administrative hurdles for providers
  
• Immediate financial impact without compromising clinical outcomes

This regulatory shift eliminates one of the biggest friction points in biosimilar adoption—making it easier for our team to deliver on the savings potential we've already forecasted through Connect 360.

SmithRx’s Advantage: From Identification to Execution

While some PBMs simply add biosimilars to their formularies and wait, SmithRx goes further. Our Drug Pathways Engine doesn’t just identify savings—it actively delivers them. Here’s how:

• Real-time eligibility identification for members on high-cost drugs like Stelara
  
• White-glove patient navigation to ensure seamless transitions
  
• Direct prescriber coordination, now simplified further by Otulfi’s interchangeable status

The result? More members accessing the right clinical treatment at the lowest cost, faster than ever.

Transparency in Action

The FDA’s approval of Otulfi reinforces the momentum toward a more cost-effective, competitive specialty drug landscape. At SmithRx, we’re ready. Our radically transparent, pass-through model ensures that every dollar saved through biosimilar adoption goes directly back to our clients—with no spread pricing, no rebate games, and no pharmacy ownership conflicts.

This is exactly the kind of proactive, high-impact change we built SmithRx to deliver.

To learn more about biosimilar interchangeability and your plan’s potential savings, reach out to your SmithRx account team.