Stelara Biosimilars: Preparing for the Upcoming Market Shift

Leveraging Stelara Biosimilars Could be a Valuable Savings Strategy in 2025

Since its introduction in 2009, Stelara (sold by Janssen) has emerged as a critical treatment for inflammatory conditions, addressing complex health challenges including Crohn’s disease, ulcerative colitis, psoriatic arthritis, and plaque psoriasis. Within the inflammatory disorder category, Stelara is the second highest drug in terms of total spend based on PSG book of business data, representing a significant area of focus. With six approved biosimilars in the U.S. as of mid-November and additional biosimilars pending FDA approval, the market is poised for transformative change in 2025. This comprehensive analysis will provide plan sponsors with crucial insights into the Stelara biosimilar landscape, offering strategic guidance to optimize drug spend and patient care.

Stelara Drug Comparisons

One cannot discuss Stelara without also mentioning Humira, the highest-selling drug in history and competitor in the inflammatory category. Comparing Humira and Stelara reveals critical distinctions that plan sponsors must consider.

Unlike Humira’s broader application, Stelara presents a more nuanced treatment profile with unique administration characteristics. Available in prefilled syringes for self-administration and single-dose vials for healthcare professionals, Stelara crosses both medical and pharmacy benefits through its diverse administration methods. The treatment’s dosing is weight-based, with cost variations directly tied to dose levels, and features a specialized protocol for gastrointestinal (GI) conditions that includes an IV infusion induction phase transitioning to self-administered injections. Stelara offers fewer indications compared to Humira, with only four total treatment areas and limited pediatric applications.

The emerging biosimilar landscape is further complicated by the interchangeability status of Wezlana (Amgen), the first Stelara biosimilar expected to enter the market in January 2025, and competition from alternative branded inflammatory medications like Skyrizi and Rinvoq from AbbVie, and Entyvio from Takeda. An additional layer of complexity emerges with questions about whether Janssen will follow AbbVie’s aggressive brand protection strategy, particularly given the subdued promotion of the company’s other branded product, Tremfya, to date. Moreover, Stelara’s inclusion in the 2026 Medicare Maximum Fair Price (MFP) program introduces significant pricing dynamics that could impact commercial plan strategies.

Market Movements: Approaches to Biosimilars (Stelara and Humira) in 2025

Several key industry players are making decisive moves that will significantly impact plan sponsors and the Stelara biosimilar market:

Evernorth announced on September 5th that it will offer an interchangeable biosimilar produced by Quallent, Cigna’s private-label subsidiary, touting pricing of more than 80% off the Stelara list price. Though not explicitly stated by Evernorth, this is assumed to be Amgen’s Wezlana and will provide a $0 copay to members who use the biosimilar. Evernorth also introduced two interchangeable Humira biosimilars in June 2024 through Quallent, the private-label Cigna subsidiary.

Optum will be offering biosimilars through Nuvaila, private labeling Amgen’s Wezlana with a $0 copay offering while also maintaining brand Stelara on formulary. Optum also announced a private-labeled Humira biosimilar offering through Nuvaila effective January 1, 2025, which excludes brand Humira for new therapy initiates while allowing current users to continue their existing treatment.

CVS Health’s strategy remains unknown with regards to Stelara biosimilars, with no information shared to date. The market expects that CVS will likely adopt a private-label strategy like that of Optum and Evernorth. CVS has followed this approach with its Humira biosimilar through Cordavis, launching a white-labeled version in April 2024 and subsequently removing the brand name Humira from its primary formulary.

The potential supply constraints of Wezlana present an additional complexity, especially if both Evernorth and Optum are promoting and private labeling the same biosimilar. With the infused version on the medical benefit, it could result in a unique scenario where patients receive brand-name infusions for induction while transitioning to biosimilars for self-administration, as these are administered under different benefit classifications.

Navigating Biosimilar Complexity: Factors to Consider

The biosimilar landscape has become remarkably sophisticated, presenting several key factors worth considering:

Pricing Complexity: Adalimumab was the first biosimilar with dual pricing options (high and low WAC), adding layers of complexity to cost analysis. Other manufacturers are offering unbranded biosimilars at a significant cost reduction. Also, PBMs are introducing their own private-label brands with direct financial incentives, creating new considerations for plan sponsors.

Rebate Guarantee Impact: Plan sponsors face challenges in adopting biosimilar-only strategies due to the effects on rebate guarantees, including per-claim fee assessments. Despite inflating the price of drugs, rebates can be a reliable source of revenue for plan sponsors.

Benefit Considerations: Pharmacy benefit biosimilars have shown slower uptake compared to medical benefit biosimilars (Remicade, Herceptin, Neulasta), requiring careful strategic planning.

Strategic Recommendations for Plan Sponsors 

Biosimilars provide an alternative to the branded product that is clinically effective and can have optimal financial outcomes. Strategy development can be complex and should include several factors in the evaluation.

Comprehensive Utilization Review

A thorough and systematic approach to reviewing current inflammatory condition treatment strategies is critical to minimize unintended movement to other more costly branded options. Plan sponsors should conduct an analysis into their existing offering and align on goals and objectives for controlling trend. This should include ensuring utilization management, benefit structure, formulary management, and PBM contract language all align with the goals of the plan sponsor and work together to achieve the lowest net cost for the plan and its members. By understanding the intricate details of their benefit strategy, plan sponsors can identify specific opportunities for optimization, cost reduction, and improved member care.

Holistic Benefit Approach

Developing a comprehensive strategy that addresses both pharmacy and medical benefits requires a nuanced and integrated perspective and is paramount in addressing biosimilar management. Plan sponsors must recognize the diverse treatment options available for inflammatory conditions, including self-administered injections, provider-based infusions, and oral therapies. This approach demands breaking down traditional silos between pharmacy and medical benefits, creating a more flexible and patient-centric benefit design. By considering the full spectrum of treatment modalities, plan sponsors can create more responsive and cost-effective benefit strategies that balance clinical effectiveness with financial sustainability.

Continuous Pipeline Monitoring

In the rapidly evolving landscape of inflammatory condition treatments, staying informed is not just an advantage – it’s a necessity. Plan sponsors should be continuously monitoring the inflammatory conditions pipeline. This includes tracking emerging therapies, new treatment indications, and the ongoing development of biosimilars. By maintaining a forward-looking approach, plan sponsors can proactively adjust their benefit designs by creating financial incentives with formulary tiering or reduced member co-share to promote the lowest net cost options, anticipate market shifts, and ensure they’re positioned to leverage the most effective and cost-efficient treatment options as they emerge.

Ensuring Stelara Biosimilar Success

While biosimilars promise potential cost savings, the path is anything but linear. Successful plan sponsors will be those who approach this transition holistically, balancing cost management with member needs and treatment efficacy. The key is not just to reduce costs, but to create a comprehensive, patient-centric approach that considers clinical outcomes, member experience, and long-term financial sustainability. Want to develop a tailored strategy for navigating the biosimilar landscape? Connect with our experts to optimize your approach.