Dracey Poore is the director of biosimilars at Cardinal Health. She is also a member of The Center for Biosimilars

Dracey Poore

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).

 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).

Image credit: TStudious - stock.adobe.com

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.

 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.

 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.

 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.

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.


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

Articles

2025 marks a pivotal year for biosimilars with Amgen's Wezlana leading ustekinumab biosimilar launches, potentially driving savings and access, as highlighted by Dracey Poore, MS, of Cardinal Health.

Welcome Wezlana: Using Adalimumab to Predict Ustekinumab Market Potential

Biosimilars offer critical savings and increased access to treatments, but they face substantial barriers before reaching patients. This series for Global Biosimilars Week, a worldwide online biosimilar advocacy event hosted by the International Generics and Biosimilars Association, focuses on 3 major areas where obstacles limit access in the US:

Payer and pharmacy benefit manager (PBM) policies

 is a media partner for Global Biosimilars Week 2024. Each article in this series will shed light on these barriers and suggest steps to enhance biosimilar access, affordability, and equity.

Interchangeability allows for a biosimilar to be switched for its reference product at the pharmacy level without requiring physician permission to do so. The policy was intended to make biosimilars more easily accessible to patients but confusion around the term calls into question whether the US needs the label at all. | Image credit: fotofabrika - stock.adobe.com

The Impact of the Interchangeability Designation on Patient Biosimilar Access

 titled “Consideration for Demonstrating Interchangeability with a Reference Product: Update.” The guidance describes considerations regarding a switching study, or studies, intended to support that a biological product is interchangeable with the reference product.

The FDA’s approach to switching studies for the interchangeability designation has evolved since the publication of the original guidance in 2019. This updated draft guidance includes recommendations intended to revise the Interchangeability Guidance and to replace certain sections of the document. An important note is that the interchangeability designation is not a clinical designation, but a regulatory designation. Each biosimilar must prove that it is “highly similar to” its reference biologic and that there are no clinically meaningful differences in safety, purity and potency.

With the original guidance in 2019, the FDA required switching studies to ensure the safety and efficacy of biosimilars. With this new guidance, the agency proposed that biosimilar drugs seeking the interchangeability designation may no longer need studies showing the impact of switching from the biosimilar to its reference biologic. For patients in particular, recent studies showed there were no difference in risk serious adverse events and treatment discontinuations between participants who switched between biosimilars and those who did not.

Conducting switching studies is also expensive for pharmaceutical manufacturers, with average costs ranging from “$100 million to $300 million.”

 Additionally, according to McKinsey, a typical biosimilar can take anywhere from 6 to 9 years from analytical characterization to approval.

 The costs are expensive, and the timeline is burdensome for bringing a biosimilar to market, especially one that has the interchangeability designation. This new guidance could aid in reducing the cost and time needed to bring a biosimilar to market and help to promote biosimilar sustainability.

When biosimilars were first introduced to the market, the FDA’s goal was to use the interchangeability designation to help educate the public about biosimilars. There is a perception that biosimilars with interchangeability are somewhat better than other biosimilars, which is not scientifically supported. This extends to providers, over 60% of which said they would only feel comfortable prescribing adalimumab biosimilars that have the interchangeability designation.

Once a biosimilar product is designated as an interchangeable biologic by the FDA, the biosimilar product may be substituted for the reference product by a pharmacist other than the health care provider who wrote the original prescription (albeit subject to state law). The interchangeability designation is only relevant to dispensing, not prescribing.

"Both biosimilars and interchangeable biosimilars meet the same high standards of biosimilarity for FDA approval and both are as safe and effective as the reference product," said Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars at the FDA.

Increasing the number of biosimilars on the market is paramount. More biosimilars means more options for patients. If a patient’s preferred biologic medicine is out of stock, it’s important that they have other potential options for treatment. Increasing the number of biosimilars on the market is important to the healthcare system, with increasing health care costs, the ability to drive down costs and provide savings to the healthcare system with biosimilars is incredibly important.

For example, according to the 2024 US Generic & Medicines Savings Report, “in 2023, savings from the use of biosimilars increased by more than 30 percent from the previous year, to $12.4 billion. Since their entry to market in 2015, biosimilars have generated $36 billion in savings for America’s patients and the US health care system.”

 By removing barriers for biosimilar manufacturers, increasing speed to market and by increasing patient education and awareness around biosimilars as a safe and effective treatment option, we can increase patient access to these medicines and bring down total costs to the health care system.

1. Considerations in demonstrating interchangeability with a reference product: update. FDA. June 20, 2024. Accessed November 13, 2024. 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-demonstrating-interchangeability-reference-product-update

2. US FDA proposes to remove switching study requirement for biosimilars. Reuters. June 20, 2024. Accessed November 13, 2024. 

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-proposes-remove-switching-study-requirement-biosimilars-2024-06-20/

3. FDA’s updated guidance on interchangeable biosimilars gets mixed response. Regulatory Focus. August 22, 2024. Accessed November 13, 2024. 

https://www.raps.org/news-and-articles/news-articles/2024/8/fda-s-updated-guidance-on-interchangeable-biosimil

4. Three imperatives for R&D in biosimilars. Mckinsey. August 19, 2024. Accessed November 13, 2024. 

https://www.mckinsey.com/industries/life-sciences/our-insights/three-imperatives-for-r-and-d-in-biosimilars

5. Cardinal Health 2023 biosimilars report. Cardinal Health. February 2023. Accessed November 13, 2024. 

https://www.cardinalhealth.com/en/product-solutions/pharmaceutical-products/biosimilars/biosimilars-report.html

6. US FDA proposes to remove switching study requirement for biosimilars. Reuters. June 20, 2024. Accessed November 13, 2024. 

7. 2024 U.S. generic & biosimilar medicines savings report. AAM. September 2023. Accessed November 13, 2024. 

https://accessiblemeds.org/sites/default/files/2024-09/AAM-2024-Generic-Biosimilar-Medicines-Savings-Report.pdf

Part 3 of this series for Global Biosimilars Week, penned by Dracey Poore, director of biosimilars at Cardinal Health, explores the critical topic of interchangeability, examining its role in shaping biosimilar adoption and the broader implications for accessibility.

Dracey Poore

Welcome Wezlana: Using Adalimumab to Predict Ustekinumab Market Potential

Breaking Down Biosimilar Barriers: Interchangeability