As you’ll see below, the combination of formulary exclusion and private labels is creating an increasingly confusing and crowded biosimilar marketplace.
For 2025, the Big Three PBMs shifted national formularies to favor their private-label biosimilars over Humira and its many biosimilar competitors. In fact, nearly all marketed Humira biosimilars are excluded from the larger PBMs’ 2025 formularies. Meanwhile, Stelara—this year’s big pharmacy benefit biosimilar launch—remains on the PBMs’ formularies, but will share space with PBMs’ private label products.
Like it or not, PBMs’ financial benefits from their private-label product align with the benefits to plan sponsors and patients. But the PBMs’ strategies, combined with the warped incentives baked into the Inflation Reduction Act, raise questions about the viability of the biosimilar marketplace.
What do you think? I encourage you to share your thoughts with the Drug Channels community on LinkedIn.
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Formulary exclusions have emerged as a powerful tool for PBMs to gain additional negotiating leverage against manufacturers. Manufacturers offer deeper rebates to avoid having their products cut from the formulary. Exclusions are one of the key factors behind the large gap between list and net prices for brand-name drugs. (See Inflation-Adjusted U.S. Brand-Name Drug Prices Fell for the Seventh Consecutive Year as a New Era of Drug Pricing Dawns.) They can also affect a patient’s out-of-pocket costs and access to a particular therapy.
Formulary exclusions block access to specific products on a PBM’s recommended national formulary. These are suggestions, not mandates. Thus, a drug’s appearance on an exclusion list does not guarantee that all patients will lose access. Plan sponsors—the PBM’s clients—can choose not to adopt their PBM’s standard formulary. However, they would then face reduced rebates and/or higher plan costs.
Here are the 2025 formulary updates for commercial clients of the three largest PBMs:
- CVS Caremark: Performance Drug List – Standard Control (January 2025)
- Express Scripts: 2025 National Preferred Formulary (NPF) Exclusions (1/3/25)
- Optum Rx: 2025 Premium Standard Formulary (1/1/25)
PBMs target both traditional and specialty products for formulary exclusion. The excluded products typically fall into one or more of the following categories:
- Brand-name products with generic equivalents or therapeutic alternatives
- Biosimilars and reference biologics with biosimilar alternatives
- Non-preferred drugs with low utilization
- Heavily promoted drugs in therapeutic classes with multiple generic alternatives
- Medicines treating chronic conditions
IN THE YEAR 2025
Here are my three takeaways from the 2025 exclusions.
1. Growth in exclusions has peaked.
Historically, the default was an open formulary, so a plan sponsor had to opt-in to a closed formulary that excluded certain products. The practice of formulary exclusion, which became prominent in 2012, shifts the default benefit design. The PBM’s standard formulary excludes certain products, so a plan sponsor must opt-in to an open formulary. Since 2012, the number of unique products excluded from the formularies of the three largest PBMs—Caremark (CVS Health), Express Scripts (Cigna), and Optum Rx (UnitedHealth Group)—has grown dramatically.
We counted the number of unique products on each company’s 2025 list. (We counted multiple formulations of a drug as a single exclusion.) The chart below tracks the growth at each company. By our tallying, each exclusion list contains more than 600 products. The PBMs sometimes—but not always—exclude many of the same medications.
As you can see above, the rate of growth has slowed in the past few years, due partly to the substantial number of products that have already been dropped. The growth in excluded products shows how competitive many therapy categories have become—and the undisclosed but presumably significant rebates generated by these products.
Note that the 2025 figures and growth rates may not correlate perfectly with growth from the 2024 figures, due to mid-year formulary changes.
We counted the number of unique products on each company’s 2025 list. (We counted multiple formulations of a drug as a single exclusion.) The chart below tracks the growth at each company. By our tallying, each exclusion list contains more than 600 products. The PBMs sometimes—but not always—exclude many of the same medications.
[Click to Enlarge]
As you can see above, the rate of growth has slowed in the past few years, due partly to the substantial number of products that have already been dropped. The growth in excluded products shows how competitive many therapy categories have become—and the undisclosed but presumably significant rebates generated by these products.
Note that the 2025 figures and growth rates may not correlate perfectly with growth from the 2024 figures, due to mid-year formulary changes.
2. Private-label Humira biosimilars now rule PBMs’ formularies.
The Humira biosimilar market finally emerged in 2023. In addition to the Humira reference product, there are currently 22 biosimilar versions of adalimumab in the U.S. market plus one “follow-on biologic” (Cordavis by AbbVie). The products have list prices that range from 14% to 95% of Humira’s list price. As I noted last year, the large PBMs’ 2024 formularies generally supported the gross-to-net bubble for Humira biosimilars.
But times have changed.
For 2025, Humira (original flavor) has or will vanish from PBMs’ standard formularies. What's more, most marketed biosimilars will be excluded from the 2025 formularies. Instead, each PBM’s formulary will give plan sponsors the option of a high-list-price biosimilar, a lower-priced private label product, and a low-list-price unbranded biosimilar.
The table below summarizes the wholesale acquisition cost (WAC) list prices for the currently marketed biosimilars along with the 2025 formulary status with the largest PBMs. As a reminder, the WAC list price does not represent the price paid by any entity within the drug channel, because it excludes rebates and such other reductions as distribution fees, product returns, discounts to hospitals, price reductions from the 340B Drug Pricing Program, and other purchase discounts. We classified products omitted from the PBMs’ published lists as formulary exclusions.
As you can see, most marketed biosimilars are excluded from the larger PBMs’ 2025 formularies. Instead, each PBM favors one or more of the biosimilars marketed by the private label businesses of an affiliated company:
Profitable for the PBMs? Certainly.
Good for plan sponsors and patients? Likely.
As I noted in my comments on the pros and cons of PBMs’ private label strategies:
3. PBMs are leading with private labels for Stelara.
But times have changed.
For 2025, Humira (original flavor) has or will vanish from PBMs’ standard formularies. What's more, most marketed biosimilars will be excluded from the 2025 formularies. Instead, each PBM’s formulary will give plan sponsors the option of a high-list-price biosimilar, a lower-priced private label product, and a low-list-price unbranded biosimilar.
The table below summarizes the wholesale acquisition cost (WAC) list prices for the currently marketed biosimilars along with the 2025 formulary status with the largest PBMs. As a reminder, the WAC list price does not represent the price paid by any entity within the drug channel, because it excludes rebates and such other reductions as distribution fees, product returns, discounts to hospitals, price reductions from the 340B Drug Pricing Program, and other purchase discounts. We classified products omitted from the PBMs’ published lists as formulary exclusions.
[Click to Enlarge]
As you can see, most marketed biosimilars are excluded from the larger PBMs’ 2025 formularies. Instead, each PBM favors one or more of the biosimilars marketed by the private label businesses of an affiliated company:
- Cigna’s Evernorth segment operates Express Scripts and the Quallent Pharmaceuticals private label business. For 2025, Express Scripts’ formulary contains Quallent-branded Humira biosimilars manufactured by Boehringer Ingelheim and Alvotech/Teva. Both Quallent products are priced midway between the high- and low-list-price biosimilars. By contrast, Express Scripts had eight products (including Humira) on its formulary at the start of 2024.
- CVS Health owns both Caremark and the Cordavis private label business. For 2025, Caremark’s formulary includes only biosimilars manufactured by Sandoz: a low-list price branded biosimilar from Cordavis along with Sandoz’ low-list-price unbranded biosimilar and its high-list-price branded biosimilar. As I describe in Humira Biosimilar Price War Update: Should We Be Glad that CVS Health and Express Scripts Are Using Private Label Products to Pop the Gross-to-Net Bubble?, CVS has led the adoption of low-list-price products.
- UnitedHealth Group’s Optum segment operates Optum Rx as well as the new Nuvaila private label business. For 2025, its Premium and Select formularies will have only two preferred formulary options: the high-list-price Amjevita from Amgen and the low-list-price Amjevita from Nuvaila (but manufactured by Amgen). Its Premium Value formulary will have the low-list-price private label product along with the low-list-price unbranded biosimilar from Boehringer Ingelheim. By contrast, Optum Rx had eight products (including Humira) on its formulary at the start of 2024.
Profitable for the PBMs? Certainly.
Good for plan sponsors and patients? Likely.
As I noted in my comments on the pros and cons of PBMs’ private label strategies:
CVS Health seems to exemplify how a PBM's financial interests can align with plan sponsors and patients. It is undeniable that CVS has driven significant adoption of a low-list-price Humira biosimilar. Plan sponsors that were paying higher net (post-rebate) prices for Humira benefited from this move. Patients who were paying coinsurance rates linked to their prescriptions’ list price also saved money. Unfortunately, we don’t know how many of Caremark’s clients remained with a high-list-price product so as to maximize the value of their rebates.
To drive biosimilar penetration, plan sponsors need to give up their addiction to rebates and reject the high-list products that inflate the gross-to-net bubble. Until that happens, we may need to accept that PBMs’ private-label strategies are less than ideal, but better than the alternatives.
For 2025, Stelara is the biggest biosimilar launch for pharmacy benefits. PBMs are leading with their private label versions rather than manufacturer-branded biosimilars. This should accelerate biosimilar adoption—while making many manufacturers question why they even bothered to develop a Stelara biosimilar. All three PBMs’ strategies differ from the launch of Humira biosimilars, which predated fully-developed private label businesses.
In 2023, the FDA approved Wezlana (ustekinumab-auub), an interchangeable biosimilar to Stelara manufactured by Amgen. Under an agreement with Johnson & Johnson, the manufacturer of the reference product, Amgen was able to launch the biosimilar no later than January 2025.
But as far as I can tell, Amgen appears to have launched the product exclusively with Optum Rx.
Optum Rx’s new Nuvaila private label Wezlana biosimilar will play a crucial role in its formulary strategy. All three of its standard formularies (Premium, Select, and Premium Value) will have the following three products on Tier 2 with prior authorization:
Express Scripts has stated that its formulary will include Stelara plus a low-list-price private label biosimilar from Quallent. CVS Caremark has not announced its strategy, but it will presumably leverage Cordavis.
The FDA has already approved six non-interchangeable biosimilars. I presume some of these products will show up on formularies soon.
Here’s another twist: Stelara is also one of the 10 products chosen by CMS for “negotiation” under the IRA. For 2026, the maximum fair price (MFP) for Stelara will be 66% below its 2023 list price.
In its June 2023 final guidance, CMS stated that it will monitor “whether meaningful competition continues to exist in the market by ongoing assessments of whether the manufacturer of the generic drug or biosimilar is engaging in bona fide marketing.” CMS has stated this monitoring will encompass multiple activities, including whether the biosimilar is “regularly and consistently available for purchase through the pharmaceutical supply chain,” market data, government price reporting, and other sources.
In 2023, the FDA approved Wezlana (ustekinumab-auub), an interchangeable biosimilar to Stelara manufactured by Amgen. Under an agreement with Johnson & Johnson, the manufacturer of the reference product, Amgen was able to launch the biosimilar no later than January 2025.
But as far as I can tell, Amgen appears to have launched the product exclusively with Optum Rx.
Optum Rx’s new Nuvaila private label Wezlana biosimilar will play a crucial role in its formulary strategy. All three of its standard formularies (Premium, Select, and Premium Value) will have the following three products on Tier 2 with prior authorization:
- Stelara
- Wezlana for Nuvaila (high list price)
- Wezlana for Nuvaila (low list price)
Express Scripts has stated that its formulary will include Stelara plus a low-list-price private label biosimilar from Quallent. CVS Caremark has not announced its strategy, but it will presumably leverage Cordavis.
The FDA has already approved six non-interchangeable biosimilars. I presume some of these products will show up on formularies soon.
Here’s another twist: Stelara is also one of the 10 products chosen by CMS for “negotiation” under the IRA. For 2026, the maximum fair price (MFP) for Stelara will be 66% below its 2023 list price.
In its June 2023 final guidance, CMS stated that it will monitor “whether meaningful competition continues to exist in the market by ongoing assessments of whether the manufacturer of the generic drug or biosimilar is engaging in bona fide marketing.” CMS has stated this monitoring will encompass multiple activities, including whether the biosimilar is “regularly and consistently available for purchase through the pharmaceutical supply chain,” market data, government price reporting, and other sources.
Presumably, the PBMs’ private label actions will count as “meaningful competition.” So, will CMS implement Stelara’s MFP in 2026?
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For 2024, there were significant formulary changes for insulin following the massive list price cuts for many of these products. There were few notable changes for 2025, so I omitted my usual review of this category. And despite the noise surrounding GLP-1 agonists, all major products are covered on the PBMs’ formularies, albeit with prior authorization and other utilization management tactics.
WILL THE BIOSIMILAR MARKET COLLAPSE?
As I warned shortly after the IRA was passed, the IRA will ultimately lead to fewer biosimilar launches, because the prospects of future negotiation could reduce biosimilar development.
CMS identifies the drugs subject to negotiation only about two years before the MFP is established. Biosimilar development requires significant investments that occur years before a biosimilar drug launches. Manufacturers will be deterred from these investments, because the negotiation process could undercut their biosimilar pricing strategy in the final period prior to launch.
When combined with the PBMs’ aggressive formulary selection process in the commercial market, the expected returns from biosimilar development become lower and more uncertain. That’s not a formula for a thriving marketplace.
Current and prospective manufacturers of biosimilars covered under the pharmacy benefit face the perennial questions about this market. Should we throw in the towel, or hope that policy makers can make structural and legislative changes that would stabilize the market while increasing competition?
I’m not sure. But biosimilar manufacturers may soon learn that you can avoid reality, but you cannot avoid the consequences of avoiding reality.
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