Category: biosimilar savings

The Bona Fide Marketing Standard and What That Means for Biosimilars and Generics

Teva received an appellate court ruling suggesting that CMS did not have authority from Congress to define a bona fide marketing standard for its IRA Medicare Fair Price negotiations. How does this relate to products targeted for IPAY negotiations and biosimilar competitors?

This week, Teva received an appellate court ruling on the IRA Medicare Fair Price (MFP) question as to whether a generic drug (or biosimilar) is to be considered a “bona fide” marketed product. This gets to the very heart of whether the reference product or originator brand is eligible for the MFP IPAY negotiations in the first place.

CMS MFP

In Teva’s case, the DC Appellate Court ruled that the challenge to the Centers for Medicare and Medicaid Services definition of bona fide marketing is valid. In its decision, the Court stated, that CMS will consider a generic as marketed “only when the manufacturer engages in ‘bona fide marketing.’ Teva says both rules exceed CMS’s statutory authority and that the Negotiation Program deprives it of a protected property interest without due process. The Government responds that the IRA bars courts from reviewing Teva’s statutory claims. Teva’s challenge to the ‘bona fide’ marketing requirement, however, is ripe for review.”

Whereas the appellate court did not rule on the merits of Teva’s challenge to the definition, it sent the question back to the District Court with the explanation that the IRA legislation did not give CMS the authority to make this determination.

IRA MFP Controversy From the Beginning

CMS decided that ustekinumab should be eligible in the first round of IPAY negotiations, despite the large number of approved biosimilars scheduled to launch prior to the implementation of its MFP-negotiated price (January 1 2026). In November 2025, CMS decided to delist ustekinumab, in the face of active biosimilar competition, though the MFP pricing ($4,695 per 30-day supply) will apply through January 1, 2027. The current WAC cost for Stelara is down to less than $500 per month. In other words, CMS is overpaying (by a lot) this year for ustekinumab.

In the case of etanercept, it was also included in the first round of Medicare price negotiations, despite two US FDA approved biosimilar products but no expectation for launches before 2028, owing to patent extensions of dubious justification. For Enbrel, the implementation of MFP discounts makes a lot of sense, despite the likely lost future revenues by the biosimilar manufacturers.

This points to the unpredictability and challenges of evaluating potential patent settlements and launch agreements with reference manufacturers. We are already seeing the potential for this to affect Keytruda, Opdivo, and other big-ticket biologics with significant upcoming biosimilar competition.

What Is Bona Fide Marketing?

Another interesting point related to the bona fide marketing requirement is that even if a biosimilar product is approved and marketed, there is no guarantee that the manufacturer will enter into large marketing programs as are commonly seen for reference or branded products. Typically, especially on the generic side, marketing budgets are relatively low end; the manufacturers may rely on automatic substitution heavily to gain prescription volume. This consideration seems to be outside of CMS’s thought process. Personally, I’ve seen only limited traditional marketing efforts on the part of biosimilar manufacturers several specific products.

This brings us back to the original question of whether CMS has the best standard for gauging the expected launch date of a generic or biosimilar at the time it produces its list of IPAY targets for the current year. We’ve seen no evidence that there is a consistent bar or protocol through which these decisions are made. Yet, these decisions may be crucial for prospective biosimilar manufacturers and for CMS itself—biosimilars with adequate competition will always produce greater discounts and lower prices than IPAY negotiations. Notwithstanding the ability of CMS to delist in the future a product that has been exposed to biosimilar competition, if it doesn’t change its view towards eligibility of reference products, CMS will continue to waste time negotiating pricing on products that will be delisted within a year of implementation. More importantly, it would lose the opportunity to save billions of dollars from biosimilar competition for the year before delisting. And isn’t saving money what this exercise is all about?

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA. 

US Humira Sales Overwhelmed by Biosimilar Competition

Adalimumab biosimilar utilization account for more than 80% of the drug category, as AbbVie’s Humira revenues dry up.

Although the numbers are hard to come by, it seems apparent that adalimumab biosimilar sales have pounded the reference product Humira into submission through the second quarter of 2026. AbbVie announced Humana net revenues of only $425,000,000 for the second quarter, another massive drop of 47% versus the same quarter of last year.

Adalimumab biosimilar sales

The utilization numbers involving biosimilar forms of adalimumab have been complicated by the significant sales of private-label versions through the big 3 PBMs and their subsidiaries. Based on reporting by IQVIA, not all of these private-label prescriptions are reported directly; however, the Pharmaceutical Resources Group recently indicated that the total share of AbbVie’s Humira prescriptions is now below 20%. This roughly aligns with the latest earnings report from AbbVie, showing titanic reductions quarter over quarter. Prior to biosimilar competition in 2023, AbbVie netted $18.6 billion in US sales; it is on track for closer to $1.5 billion through the end of 2026.

As pointed out by Bryce Platt at Drug Channels Institute, and by us in the past, the lowest-price discounting for adalimumab biosimilars has not guaranteed increased preferential coverage for utilization. Instead, private-label contracting by the biosimilar manufacturer seems to move the needle more significantly.

As Skyrizi and Rinvoq Fill the Revenue Gap, Do Health Plans Further Restrict Their Use?

In any case, no one is feeling sorry for AbbVie these days because of the bloated numbers being posted for Skyrizi and Rinvoq sales. These are easily taking up the slack for the hole created by cratering Humira revenues. As a related question, it would be interesting to better understand whether health plans have now firmly decided to require a low-cost adalimumab step prior to covering either Skyrizi or Rinvoq for patients with the dozen or so immunology indications that they are approved to treat.

It’s not a simple question. For example, UnitedHealthcare’s medical coverage policy for Skyrizi in plaque psoriasis requires use of “documentation of moderate-to-severe disease plus failure of at least one conventional systemic therapy (methotrexate, cyclosporine, PUVA, or acitretin) OR prior treatment with any targeted immunomodulator like TNF inhibitors or other biologics.” It also varies by indication: CIGNA’s coverage policy for Skyrizi and Rinvoq in Crohn’s disease and psoriatic arthritis lists it as a preferred step 1 agent, along with adalimumab, Tremfya, Taltz, and ustekinumab biosimilars, whereas Rinvoq is nonpreferred (where patients are directed to adalimumab specifically). This is accompanied by many specific criteria allowing for exceptions to the coverage policy. Then, of course, is the difference between medical coverage and pharmacy coverage policies for these mostly self-administered products.

From a quick scan of these coverage policies, it does appear that the adalimumab and ustekinumab biosimilars have been firmly set as first-step options among biologics. The question of whether their own use require fewer prior authorization criteria (or even no prior authorization scrutiny?) has not been answered. It is extremely important to point out that, as inexpensive as adalimumab biosimilars are today, and as easy as they are to access, these are biologic agents with potentially serious side effects and complications. They are not for every patient, and therefore, prior authorization criteria should probably remain in place, even as they grow in utilization and remain inexpensive.

In Other Biosimilar News

According to an agreement between Sandoz and Shanghai Henlius, Sandoz will have global commercialization rights (outside of China) to up to 10 potential biosimilar candidates being developed by Henlius, including three announced agents: evolocumab (reference product, Repatha) for the treatment of hypercholesterolemia, belimumab (Benlysta) for the treatment of systemic lupus, and cetuximab (Erbitux) for the treatment of colorectal cancer.  

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA. 

MFP Agreements Don’t Guarantee Better Patient Access

A study by IQVIA finds that first prescription rejection rates were unchanged for the first MFP negotiated drugs after implementation in January.

A notable study by IQVIA found that for the first drugs subject to Medicare maximum fair price (MFP) agreements, initial rejection rates were not significantly lower than before the new prices took effect in January 2026.

One of the main stipulations of the MFP agreements was that if the reference drug manufacturer signed an MFP agreement, Medicare Part D drug plans and Medicare Advantage plans would have to cover the drug on their formularies.

Enbrel and Stelara Rejection Rates

Enbrel and Stelara are the two Part D drugs of interest in this first round of Medicare MFP negotiations. Enbrel has no current biosimilar competition (though 2 approved products), and Stelara has plenty of it.

These two drugs comprise the immunology sector of the first 10 drugs subject to MFP. According to the IQVIA data, the initial rejection rates for those new to the brand were 59% for the first quarter of 2026. When looking forward 30 days, the average rejection rate on appeal was 22%. In the past 5 years, the initial rejection rates ranged from 61% to 73%. IQVIA did not break down the rejection rates for the two individual biologics.

In their post, IQVIA said, “Expectations for Medicare drug price negotiation to improve patient access have yet to come to fruition. Even more concerning, additional future IPAY-selected drugs are in the immunology and oncology therapeutic areas and other therapeutic areas with similar costs and treatment complexity, facing similarly high levels of payer control.”

The Result of Heavy Biosimilar Competition?

Granted, both etanercept and ustekinumab are unusual products, in that they are both subject to heavy competition from other agents within the same or similar drug categories. In fact, the MFP for Stelara is not competitive with several ustekinumab biosimilars on the market today. The existence of over 10 adalimumab biosimilars at deep discounts would be a highly attractive prior step before approval of either Enbrel or Stelara. Therefore, it is unlikely that payers will significantly change coverage policies to improve access to these two agents under current conditions.

As more Part B medications are subject to MFP negotiations, patient access may change somewhat for those particular drugs. However, one must remember that patient access improvement was not the primary goal of Medicare MFP negotiations under the Inflation Reduction Act. The real goal was cost reduction for the Centers for Medicare & Medicaid Services.

As we can see, cost reduction may not equal better patient access, even if deep price reductions on biologics are available on direct-to-consumer sites because of relatively high patient out-of-pocket costs. Therefore, this finding is not surprising. We saw the same lack of effect when the adalimumab biosimilars were first introduced in 2023: Much lower costs didn’t result in prescriptions to patients; only formulary policy changes did.

Instead, I tend to view IQVIA’s study as more supportive of a 360-degree view of the effectiveness of biosimilar competition for these two medications.

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA. 

Why State Employee Health Plans Should Push Hard for Biosimilar Use

A focus on biosimilars will save individual state employee health plans a conservative average of over $17 million, based on net costs.

A new survey from the Pacific Research Institute found that a greater focus on biosimilar utilization will save individual state employee health plans on average over $17 million each year, based on net costs.

In 2024, the year on which savings calculations were based, adalimumab biosimilars had begun to significantly cut into Humira’s market share, and savings were already being registered in a number of biologic categories, especially the oncology-related therapies.

State employee health plan savings with biosimilars

The study used data from CMS, IQVIA estimates, and a third party’s estimate of nonretail prescription drug expenditures. Based on these three sources, state private health insurance plans spent $20 billion on biologics in 2024. The author, Wayne Winegarden, PhD, Senior Fellow at Pacific Research Institute, confirmed to BR&R that these estimates are based on net prices, not gross costs. He estimates that roughly one-quarter of those expenditures were spent on biosimilars in categories of biologics with biosimilar competition, or a total of 7% of overall biologic expenditures.

State Employee Health Plans Save Big With Biosimilars

The research assumed two different scenarios: (1) biosimilars attain 52% of the biologic volume in categories with biosimilar competition (or 15% of overall biologic expenditures) and (2) 81% within those categories, or 24% of the overall biologic spend.

The author found that across the US, savings ranges from $871 million to $1.8 billion each year. From the analysis of individual states’ public employee health plans, biosimilars will save annually in the range in the from $0.9 million in Wyoming to $88.4 million in California (conservative scenario). In the more aggressive scenario, the biosimilars savings range was $1.8 million in Wyoming and $178.9 million in California.  

Dr. Winegarden concludes, “Due to the savings potential, prioritizing biosimilars in state employee health plans will enhance the fiscal soundness of the state budget while ensuring state employees have access to efficacious treatments. This is an easy win-win outcome that will benefit both taxpayers and state employees.”

In Other Biosimilar News

According to a report in the Korea Biomedical Review, Celltrion was given the FDA interchangeability designation for its rituximab biosimilar product Truxima. This is perplexing for all of the reasons I’ve stated in the past: (1) the drug is not covered under the pharmacy benefit so it is not subject to the sole automatic substitution purpose of the designation and (2) the interchangeability designation does not in any way infer that the product is better than another biosimilar, yet the report noted that “Truxima remains the only rituximab biosimilar officially recognized by the FDA as interchangeable with the reference product, which it believes will provide a competitive advantage through greater physician confidence and market differentiation.” Any suggestion that an interchangeable is better than a conventional biosimilar is false. Rituximab biosimilars were first approved in 2018. How much additional confidence do prescribers need?

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated biosimilar approval database.