Welcome Wezlana: Using Adalimumab to Predict Ustekinumab Market Potential

2025 has started off strong for biosimilars in the US with the entrance of the first biosimilar referencing Stelara (ustekinumab), Amgen’s Wezlana (ustekinumab-auub).1 Wezlana launched with a similar strategy as the CVS Health’s Cordavis model in the adalimumab biosimilar space, adopting an exclusive procurement business through Optum Rx subsidiary Nuvaila and offering a dual wholesale acquisition cost (WAC) pricing strategy (high WAC, 5.5% less than Stelara; low WAC, 81% less than Stelara).

There are several other ustekinumab biosimilars preparing to launch in 2025 without an exclusive procurement strategy, which again aligns to the variable landscape we have seen in the adalimumab market. The biosimilar market continues to evolve seeking to navigate a complex ecosystem.

Adalimumab biosimilar market data provides insights for other pharmacy benefit products such as the ustekinumab biosimilars. In the first-year post-launch (2023), adalimumab biosimilars only achieved 2% market share.2 In the second year of competition (2024), they reached 28% market share. Of that 28%, the majority share of 18% was held by the Cordavis’s Hyrimoz product. It will be interesting to see if the ustekinumab biosimilars trend similarly the first 2 years of launch, or if the adalimumab market paved the way to greater and faster acceptance amongst stakeholders.

In 2023, approximately 80% of the Stelara sales were attributed to Crohn disease (CD) and ulcerative colitis (UC), which informs us that gastroenterology (GI) will be the predominant therapeutic space in which the ustekinumab biosimilars will launch.2 GI practitioners are accustomed to biosimilars due to products like infliximab, however, biosimilar acceptance and adoption in the GI space has historically been slower than what we have seen in other therapeutic areas such as Oncology. Data does illustrate a significant rise in GI biosimilar prescriptions over the last several years, particularly with the infliximab biosimilars treating inflammatory bowel disease, which suggests an increase in confidence and comfortability within the GI space.

Organizational support is critical to the success of biosimilars. The American Gastroenterological Association (AGA) endorses biosimilars when appropriate and has made great efforts to educate and inform their prescribers and patients. The AGA website is an excellent resource for biosimilar education and resources. New molecules coming to the market could equate to new patients accessing biosimilars for the first time. The need for education and awareness is crucial for all stakeholders of the health care ecosystem.

The FDA has now approved 6 additional ustekinumab biosimilars. Launches are expected for these products as early as February 2025. The Stelara market is one of the highest-grossing biologic markets in the US. According to IQVIA, the invoiced sales of Stelara in 2024 reached $17 billion.2 The ustekinumab biosimilars launching in 2025 plan to launch with the same indications as the Stelara product, which could provide impactful savings to the health care system. 2025 is a pivotal and exciting year for biosimilars to enhance patient access to expensive biologics in the GI space, as well as reduce the overall burden on the health care system.

To learn more, visit cardinalhealth.com/biosimilars.

Author Bio

Dracey Poore, MS, serves as director of biosimilars and emerging therapies at Cardinal Health and a member of The Center for Biosimilars® Advisory Board. Prior to her work at Cardinal Health, she worked at Organon, and at Merck prior to that. Dracey is an experienced marketing and brand strategist with demonstrated success across various managed markets, pricing, contract negotiations, and various payers, including group purchasing organizations, government, and 340B contracts.

References
1. Jeremias S. Welcome Wezlana: the first Stelara biosimilar to launch in the US. The Center for Biosimilars. January 31, 2025. Accessed February 10, 2025. https://www.centerforbiosimilars.com/view/welcome-wezlana-the-first-stelara-biosimilar-to-launch-in-the-us

2. Assessing availability of new drugs in Europe, Japan, and the U.S. IQIVA Institute for Human Data Science. December 2024. February 10, 2025. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/assessing-availability-of-new-drugs-in-europe-japan-and-the-us