How Comfortable Are Neurologists With Biosimilar Prescribing?

With the October 2025 launch of Tyruko (natalizumab), neurologists have now been exposed to three different biosimilar categories, and one has been around since before the COVID-19 pandemic.

It’s logical to assume that when a specialty is exposed to biosimilar competition for the first time, acceptance and uptake of the biosimilar might be slow. The effort to educate specialists around the safety and efficacy of the biosimilar(s) may take time. In the past, manufacturers of the reference products countered competition with misleading marketing efforts to preserve their revenues. To cite just two examples, this occurred with gastroenterologists with the introduction of infliximab and with ophthalmologists with the launch of the first ranibizumab biosimilar. And then of course, there was the slow acceptance of adalimumab, based on different formulations.

Last October, the natalizumab biosimilar Tyruko was launched by Sandoz, primarily for the treatment of multiple sclerosis. Will neurologists’ biosimilar prescribing follow this stunted path? Only if you think natalizumab marks the first foray of biosimilars into the field of neurology medicine. In reality, this is not the case.

Eculizumab and Rituximab Biosimilars in the Neurology Toolbox

One reason that neurologists’ biosimilar prescribing will be quicker is that natalizumab is actually the third biosimilar used by these specialists. Eculizumab is usesd to treat patients with the neurological condition generalized myasthenia gravis. That drug has been available as a biosimilar since March 2025.

Although many neurologists have moved from the eculizumab reference drug Soliris to the follow-on brand Ultomiris, the appearance of biosimilars has likely exposed them to more prior authorization and/or step therapy, encouraging the use of lower-cost eculizumab biosimilars. Additionally, their experience with buy-and-bill eculizumab biosimilars gave them a brief preview of buy-and-bill reimbursement for the natalizumab biosimilar.

Another factor impacting neurologists’ biosimilar prescribing is not so obvious: A significant portion have been prescribing rituximab and its biosimilars off label to treat some neurologic disorders, including myasthenia gravis, multiple sclerosis, and neuromyelitis optica spectrum disorder. And rituximab biosimilars were approved since 2018.

Neurologists May Be More Comfortable With Biosimilars Than You Think

In working on a survey of 40 practicing neurologists for a biosimilar manufacturer and marketer, it became apparent that the respondents were far more familiar with biosimilars than we may have assumed.

In the case of the present survey, which was conducted just before the launch of Tyruko, 41% of the neurology sample had indicated they had experience with rituximab biosimilar prescribing s within the previous 12 months. This may have contributed to the view by 40% of the sample that the use of either eculizumab or natalizumab biosimilars would not have any effect on their practice. An additional 22% believed the biosimilars might actually result in greater profits. This should certainly make it easier for makers of biosimilar forms of market-leading Ocrevus, when they are launched in 2028.

Watch for further insights from this survey project in the next month, once the full results are published.

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.

The Effect of MFP on Enbrel Sales, and Biosimilar Implications

In reporting its 2026 first-quarter earnings, Amgen indicated a 37% reduction in Enbrel sales revenue compared with the first quarter of 2025. Was this related directly to the January 1 implementation of the MFP price for Enbrel or just a continuing trend in its sales? What does it mean for the etanercept biosimilars?

On January 1, 2026, Medicare-negotiated prices for the first set of targeted drugs went into effect. Among these products was Enbrel (etanercept), the only drug on this list with impending biosimilar competition. Although biosimilar competition in this category will not be introduced until 2028, the maximum fair price (MFP) program will threaten manufacturers of etanercept biosimilars as well as other biosimilar makers.

Amgen Continues to See Enbrel Sales Decline

In reporting its 2026 first-quarter earnings, Amgen indicated a 37% drop in Enbrel sales revenue compared with the first quarter of 2025. In its press release, Amgen stated, “The decline in net selling price reflects the impact of US Medicare part D price setting under the Inflation Reduction Act…as well as increased 340B program mix.” We assume that this also considers increased catastrophic benefit liability for the manufacturer owing to part D redesign.

None of this is surprising: Amgen has reported lower net sales revenues for Enbrel every year since 2020. Nearly all of its Enbrel sales revenue is US-based. Three etanercept biosimilars have been sold in Europe for more than 6 years, and Pfizer holds commercial rights to Enbrel outside of North America. It reported Enbrel sales revenues of $627 million in 2025, which is also 9% lower than in 2024).

This continuing downward trend in the US is likely the result of several factors: (1) heavy competition from other branded anti-TNF agents and interleukins, (2) lower-priced biosimilar competition in the adalimumab and ustekinumab categories, (3) the recently implemented MFP pricing, and (4) other market factors (e.g., 340B mix of sales, part D redesign).

The MFP Effect: A 67% Discount on Enbrel and What It Means Down the Road for Biosimilar Makers

The lower MFP price for Enbrel, which is 67% below the previous WAC price, does result in lower net selling price for Amgen and thus lower revenues. We just don’t know how much it contributed to Enbrel’s first-quarter sales decline.

Overall, this spells worrisome news for the two currently approved etanercept biosimilars (by Samsung Bioepis and Sandoz). It likely means that whatever market shares the biosimilar manufacturers can attain when they do launch, it will be worth significantly less in total revenue dollars than they initially anticipated. If we extrapolate the sales figures from the first quarter to the full year, total 2026 US revenue for Enbrel will be approximately $1.3 billion. Based on continuing revenue declines (not necessarily from prescription volume declines), this figure can easily dip below the $1 billion mark (i.e., the definition of a blockbuster drug) by the end of the year.

Because of the multiple factors affecting Amgen’s Enbrel earnings, it may not provide the best evidence to support biosimilar manufacturers’ fears about the Inflation Reduction Act, reported earlier. Yet it does make sense that the MFP will lower sales expectations for biologics that were (or are) considered targets for biosimilar competition. This will make the decision to spend R&D resources on those prospective biosimilars less enticing.

First US Approval for a Golimumab Biosimilar: Immgolis and Immgolis Intri to Launch by End of 2026

Bio-Thera Solutions and Accord Biopharma received an FDA approval on May 15, 2026 for the biosimilar forms of Simponi and Simponi Aria. Dubbed Immgolis and Immgolis Intri, this first-in-class golimumab biosimilar should be available before the end of 2026.

On May 15, the FDA approved the first golimumab biosimilars, Immgolis and Immgolis Intri (golimumab-sldi) for the reference products Simponi and Simponi Aria, respectively. Commercialized in the US by Accord Biopharma, Immgolis was developed and manufactured by Bio-Thera Solutions. Immgolis is administered by subcutaneous injection in a single-dose prefilled syringe; Immgolis Intri is administered as an intravenous infusion prepared from a single dose vial.

Immgolis is approved for the treatment of severely active rheumatoid arthritis (RA), in combination with methotrexate, and for the treatment of moderately to severely active ulcerative colitis. The Immgolis Intri formulation is approved only for adults with moderately to severely active RA in combination with methotrexate. This does not represent the full set of indications of the reference product, as Simponi is also indicated for the treatment of active psoriatic arthritis alone, or in combination with methotrexate and active ankylosing spondylitis.

“As the first golimumab biosimilars approved in the US, Immgolis and Immgolis Intri represent a meaningful new option for people in the US who are living with the chronic, debilitating autoimmune conditions associated with moderately to severely active rheumatoid arthritis or ulcerative colitis and need more affordable medication,” stated Chrys Kokino, President of Accord North America, in the company’s press release. He added, “This approval answers a clear demand in the US market and helps advance our ambitious goal to bring 20 biosimilars to market by the year 2030.” Launch is expected by Accord BioPharma in the fourth quarter of 2026.

The outlook for biosimilar competition in this category is somewhat limited, in that there has been only one other publicly disclosed golimumab biosimilar. That product, AVT05, is produced by Alvotech and will be commercialized by Teva postapproval. Its initial 351(k) application was accepted by the FDA in January 2025, but the drug makers were issued a complete response letter for manufacturing issues in November 2025.

Golimumab is a TNF inhibitor, and Immgolis will compete against not only the other biosimilar TNF competitors (e.g., adalimumab and infliximab) and their low net prices, but with the approved interleukin biosimilars (e.g., ustekinumab) as well for the same autoimmune indications.

More on the Dynamics of the Biosimilar Marketplace

In this post, we summarize market share and average sales price (ASP) trends for several notable biologic categories with biosimilar competition, courtesy of the Q2 2026 Samsung Bioepis Market Trend Report.

Over the years, we’ve observed the effect of biosimilar competition on biologic pricing, generally in the form of ASP and wholesale average cost (WAC) declines. Even when biosimilar competition was less than robust, prices declined steadily for some drug categories, shockingly fast for others. But the savings keep accumulating.

The Pegfilgrastim ASP Roller Coaster

The pegfilgrastim category has been fascinating since its first biosimilar was launched in late 2018. The ASP declines, plateaus, rises, and falls once again have been chronicled in this column in the past. Perhaps the main take away of the biosimilar ASP chart featured in the latest Samsung Bioepis Market Trend Report is that the graphic jumble of ASP movements have finally coalesced into a narrower range, between $1,813 at the top end for Stimufend and $839 at the bottom end for Fulphila; the latter is also the market leader with 41% share (as of Q4 2025).

The wild ASP rollercoaster of chart lines has taken three years and some stops and starts by manufacturers like Sandoz before reaching this station. Market share in this category is dominated by biosimilars, with Neulasta accounting for only 13% of volume; however, Onpro is not included in IQVIA’s data, so it is far from the whole story.

Biosimilars Leading the Autoimmune Field

On the autoimmune side, biosimilars have just reached a majority share of the infliximab market, with 51%, but the reference product (branded and unbranded Remicade) still has the greatest volume (49% vs. 30% for Inflectra). Here also, the ASPs of the various products have settled into a narrow range ($237-$293).

Based on the IQVIA data, the latest Samsung Bioepis report concedes that Humira’s prescription volume has been eclipsed by the mass of adalimumab biosimilars currently on the market. The authors peg Humira’s market share at 40%, and this is probably generous, because IQVIA does not track Cordavis private-label volume. The individual biosimilar shares are closely grouped, with Hyrimoz at 13% down to Amjevita at 4% (Nuvaila’s private-label version adds another 5%), and at least four others combining for 7% in total.

The tocilizumab market, which is about 2 years old, is showing slow gains for its three biosimilars, which comprise 18% of total prescription volume. It is led by Tyenne (16%), which also has the lowest published ASP, at $1,607, a 23% discount to the reference product’s ASP.

For ustekinumab, Stelara’s market share had already been knocked down to approximately 70%, as of Q4 2025, a far faster trajectory than that seen with adalimumab. Yesintek, at 11%, holds a narrow lead over Wezlana (7%). As we have seen at their introductions, the WAC pricing discounts have been extremely steep, led by Starjemza (–98%, or $500 total). But this is the first quarter for published biosimilar ASPs in the category, which come into play because ustekinumab requires an infusible loading dose for some indications, which is given by a health care provider under Medicare Part B. The loading dose ASPs have a wide initial range, from $286 for Steqeyma, to $1,643 for Pyzchiva. The average ASP of the biosimilars is $753, compared with $1,426 for Stelara.

A Failed Biosimilar Ophthalmology Category, or not Really?

Overall, the report details a generally, very positive biosimilar story. The one drug category where this is not the case, is ranibizumab. With the pause in commercialization of Cimerli, the low uptake of Byooviz, and the dominance of aflibercept and bevacizumab in the injectable retinal care product, marketshare of the reference product Lucentis has returned to 98%. Despite the lack of biosimilar success, the ASPs for the category hover between $320 and $398, a 72% drop cited by the report’s authors. Unfortunately, IQVIA data does not yet include the effect of the launch of the first biosimilar on the aflibercept market. We’re betting on another big success story here.

Market Share vs. ASP: Do Oncology Biosimilar Trends Make Sense?

The latest Samsung Bioepis Biosimilar Market Report (Q2 2026) was released yesterday, and it reveals a host of intriguing movements in both price and market share of biosimilar agents. In this post, we’ll look at the oncology category.

The movements of one of the most established drug categories—trastuzumab—caught my eye in the newest release of the Samsung Bioepis Biosimilar Market Report. It perhaps highlights how the US drug pricing system seems to encourage strange market trends.

Biosimilars have been available in the category since 2020. One might expect the story of the trastuzumab biosimilar market to be stable and essentially straightforward. This is true when viewing market share data. Three products have shares of 24% and above: Kanjinti (31%), Trazimera (25%), and Ogivri (24%), and these shares have not moved much over the course of a couple of years. However, the average sales price (ASP) listings for these products are all over the map, and they are moving in wildly different directions.

The Case of Trazimera

Pfizer’s Trazimera is of particular interest. Based on the latest IQVIA data, the biosimilar’s ASP bounced up from $112 to $205 in the last quarter, after dropping a whopping 88% (from $938 to $112) in Q4 2025. Trazimera’s ASP is currently 80% below its nearest price competitor (Ontruzant).

On the opposite side of the scale, Kanjinti still has the highest ASP of any trastuzumab biosimilar, at more than 10 times the price of Trazimera, yet it is the market share leader (Table). For comparison, the reference product Herceptin has an ASP of $2,909, about 19% higher than Kanjinti’s but has only 3% market share, which is the only thing here that makes sense.

Trastuzumab Biosimilar/Market Share	ASP Pricing	Percent Lower Than Current ASP of Reference Product
Trazimera (25%)	$205	93%
Ontruzant (2%)	$1,109	65%
Ogivri (24%)	$1,270	56%
Hercessi (3%)	$1,358	53%
Herzuma (2%)	$2,120	27%
Kanjinti (31%)	$2,135	27%
Data from Samsung Bioepis Biosimilar Market Report Q2 2026.

Although this may be another case of a buy-and-bill product being preferred because of a higher price and thus higher reimbursement, it does not explain why Trazimera holds a full quarter of the total trastuzumab market. It could be that this is the product preferred by systems and practices being paid through value-based reimbursement, like shared savings. However, the other market leader, Ogivri, has a midrange ASP and a similar marketshare.

In the bevacizumab market, this appears not to be the case. Mvasi, with a 51% market share, has the lowest ASP. In the case of rituximab, Ruxience owns 39% of the market and is by far the lowest-priced agent. However, the second lowest-priced agent (Riabni) has only a 7% share, and Truxima, with a 31% share, costs three times as much as Ruxience.

In the next couple of posts, we’ll delve into some additional interesting biosimilar market share market trends, as described by the latest data.

FDA vs. EMA Biosimilar Approvals, an Update

In 2026, the number of EMA-approved and FDA-approved biosimilar drug categories are now even. However, the number of marketed US biosimilars is less than half of that in the EU.

When looking at the approvals by the European Medicines Agency (EMA) of biosimilars since the initial approval back in 2006 for somatropin biosimilar, it becomes clear that the US FDA has caught up in terms of the drug categories for which biosimilars have been approved. However, the total number of approved biosimilars in the UK still far outpaces those in the US, on the order of 168 to 81 (I don’t count each denosumab molecule twice, against the reference products Prolia and Xgeva). That’s in 26 drug categories (compared with 20 in the US).

150 Marketed Biosimilars in the EU

According to the Generics and Biosimilars Initiative (GABI), presently 150 biosimilars are actually available for marketing. Digging into the number of biosimilars available in any one category, such as denosumab, the EMA has approved 14 manufacturers’ products (under 28 different brands), compared with 11 in the US, guaranteeing intense competition.

Several drug categories that the EMA list as biosimilars were not originally considered biologics by the FDA or were converted to the biologic category in 2020; however, this was after pharmaceutical company interest waned in the US for these drugs. This was the case for follitropin, enoxaparin, somatropin, and teriparatide. Basaglar is approved as an insulin glargine biosimilar by the EMA but as an insulin glargine follow-on product (or 505[b]2) by the FDA. And the EMA split epogen biosimilars into two categories, epogen alpha and epogen zeta, for some reason, whereas we only have the former.

There is only one drug category for which the FDA has approved a biosimilar that the EMA hasn’t (at least for now): That is pertuzumab. Partners Henlius and Organon have the sole FDA-approved biosimilar in the category.

Other fascinating areas of difference among the regulatory regions is that there are six ranibizumab biosimilars in the EU as opposed to only two active in the US; there are 14 ustekinumab biosimilars approved by the EMA as opposed to 8 in the US (not including private labels).

Of course, the number of approvals does not foretell the number of launches, especially in the US, where we are still awaiting the first etanercept biosimilar launch, 10 years after Europe’s introduction.

The real question is, who will delve quickly into the biosimilar void?

In Other Biosimilar News

Teva announced on March 30 that it received FDA approval for its Prolia biosimilar Ponlimsi (denosumab-adet). The drug is approved for all of the bone health indications of the reference product Prolia. Originally designated TVB-009, it is also under consideration by the FDA for Xgeva’s oncology bone health indications. It is the 10th denosumab biosimilar approval to date.

In other Teva news, the company also announced that the FDA has accepted its 351(k) application for TEV-45779, its omalizumab biosimilar. An FDA decision is expected in Q1 2027 on this third Xolair biosimilar product.

Samsung Bioepis, Sandoz Forge Deeper Biosimilar Ties

Five early-stage biosimilar candidates from Samsung Bioepis will be marketed in various parts of the world by Sandoz, including SB36, for which Sandoz will hold marketing rights in the US.

Samsung Bioepis, which had earlier this year announced a substantial biosimilar infusion to its pipeline, entered into a marketing agreement on March 18th with Sandoz for at least one of its early-stage biosimilar candidates in the US.

The company specifically announced that its biosimilar for vedolizumab (SB36) will be marketed by Sandoz in the US and in most world markets, excluding Southeast Asia.

Vedolizumab Biosimilars and More in the US?

Beyond this Entyvio biosimilar candidate, Samsung did not suggest that Sandoz would be its US marketing partner for its other biosimilar targets, which include Keytruda, Taltz, Ocrevus, among others. However, Samsung Bioepis did state in its press release that the new agreement covers up to five biosimilar candidates (which may cover various global markets).

“We are very pleased to expand our successful partnership with Sandoz and to secure commercialization agreement for multiple biosimilar assets that are in early-stage development. The agreement is a significant progress in improving access to biologic medicines for patients living with debilitating conditions, who have limited access to life-changing medicines,” said Kyung-Ah Kim, President and Chief Executive Officer, Samsung Bioepis.

The Sandoz Biosimilar Pipeline Grows as Well

On the other hand, Sandoz has its own Keytruda biosimilar candidate (GME751), which suspended its late-stage clinical trial before the FDA’s announcement of its planned move away from requiring phase 3 trials. Sandoz also has its own Opdivo and Yervoy biosimilar candidates.

This arrangement fortifies Sandoz’s existing partnership with Samsung Bioepis, which already includes marketing agreements for the latter’s ustekinumab (Pyzchiva) and eculizumab (Epysqli) biosimilars. It adds to the roster of biosimilars in Sandoz’s pipeline as well.

Richard Saynor, Chief Executive Officer, Sandoz, stated in a press release, ”This partnership underscores our unwavering commitment to expanding access to affordable, high-quality medicines for patients worldwide. It is another important step toward capitalizing on the unprecedented biosimilar market opportunity over the next decade while also strengthening our partnership with Samsung Bioepis.”

As Oncology Biosimilar Acquisition Prices Fall for Hospitals, Biosimilar Adoption Rises

A recent study published in JAMA found that as the acquisition prices of bevacizumab, rituximab, and trastuzumab fell from 2020 to 2024, hospitals’ profits on each biosimilar purchase increased, and the uptake of these oncology biosimilars rose quickly. This could be an important lesson for the upcoming Keytruda and Opdivo biosimilar launches.

Researchers from the University of California, Berkeley and Brown University found that for the oncology therapies bevacizumab, rituximab, and trastuzumab, hospitals profited handsomely from the use of biosimilars over their reference products. Their study was published March 11 in JAMA.

From 2020 to 2024, the hospitals’ uptake of bevacizumab jumped from 32% to 93%. Similar leaps were seen for trastuzumab biosimilars (from 37% to 87%) and for rituximab biosimilars (from 18% to 84%). — Adapted from Robinson et al. *JAMA* March 2026

The overall biosimilar uptake of these three products has been a model for the rest of the biosimilar industry in that uptake was rapid (achieving >60% utilization by year 3) and > 60% average sales price (ASP) declines occurred over four years. These biosimilars first entered the market in 2019. According to the Samsung Bioepis Biosimilar Trend Report, ASPs have now dropped below $1,000 for several biosimilars in all three drug categories, with the most extreme drop for Trazimera, a biosimilar of trastuzumab, at an ASP of $112 per 420 mg dose. Biosimilar uptake is over 85% for the bevacizumab and trastuzumab categories and at 78% for rituximab.

Biosimilar Acquisition Prices Dropped, Hospital Profit Rose

The researchers collected data from Blue Cross Blue Shield health insurance plans that contained drug acquisition costs, drug reimbursements by the insurers, hospital eligibility for 340B discounts, and other information from 2020 to 2024. The database covered more than 66,000 patients who received oncology biologics and biosimilars in more than 1500 hospitals.

They found that the biosimilar acquisition prices paid by the hospitals to manufacturers (or intermediaries) declined by 60% for bevacizumab, 72% for trastuzumab, and 63% for rituximab over that period. However, reimbursements from insurers declined only by 32%, 36%, and 34%, respectively, resulting in additional profit for the hospital systems.

With the increased profit from these three oncology biosimilar categories, the hospitals increasingly favored the biosimilars over the reference biologics. From 2020 to 2024, hospital uptake of bevacizumab jumped from 32% to 93%. Similar leaps were seen for trastuzumab biosimilars (from 37% to 87%) and for rituximab biosimilars (from 18% to 84%).

These figures would seem counterintuitive, if one considers the pervasive 340B discounts used by hospital systems for outpatient drugs. The authors assumed a 340B discount of 65% of the ASP price. If that is factored in, it would make most sense for the hospital system to purchase at the low 340B price, and seek reimbursement from insurers at the higher price, further widening their profit on each drug utilized. The researchers found that “Hospitals eligible for federal 340B acquisition price discounts were associated with a lower probability to adopt biosimilars than noneligible hospitals for trastuzumab and rituximab.” They also found that “for-profit hospitals were associated with higher probability of biosimilar use for trastuzumab and rituximab.

The study authors believe that gainsharing or shared-savings payment methodologies by Medicare accounted for the overall preference for biosimilars. These gainsharing payment methods, they assert, have also become popular in the private sector as well.

This experience may well be applied to the new oncology biosimilars that will be introduced for Keytruda, Opdivo, and others over the next two to three years.

In Other Biosimilar News

Celltrion announced that its tocilizumab biosimilar (Avtozma) has been launched in the US, marking the first intravenous and subcutaneous biosimilar interleukin-6 receptor antagonist. It is one of three Actemra biosimilars approved in the US.

The FDA’s New Draft Guidance Contributes to Streamlined Biosimilar Development

The FDA positions non-US-licensed reference products as adequate for clinical pharmacokinetic investigations and to reduce data redundancy

The FDA on March 10th released new draft guidance for the biosimilar industry that begins to tie together some of the concepts in streamlining biosimilar development that has been discussed for some time now. The new guidance goes beyond the phase 3 comparative efficacy study mandate removal in October 2025 and touches upon the need to test a biosimilar against a US-licensed reference product as well as the need for redundant pharmacokinetic testing requirements.

FDA releases new draft guidance streamlining biosimilar development

In the fourth revision of its Q&As on biosimilar development , the FDA specifies that, in certain circumstances, a sponsor can use data from a non-US-licensed reference product for comparison if it can scientifically justify why “such comparative data are relevant to the assessment of biosimilarity to the US-licensed reference product.” This assumes that the non-US product has been approved, licensed, and under the regulatory authority of an organization with similar standards to those of the FDA.

This new guidance could have two significant effects: (1) It would reduce the need for replicative pharmacokinetic investigation (to show the equivalence of the ex-US reference product to the US-licensed reference product and (2) it would remove the need for biosimilar companies to run additional clinical pharmacokinetic studies on a new biosimilar candidate. With reference products costing far less outside the US, not requiring a US-licensed comparator product would save biosimilar manufacturer significant R&D dollars in the purchase of the many doses required for analytic testing.

The FDA also specifies that “Differences in strength or dosage form between the US-licensed reference product and non-US-licensed comparator product do not necessarily preclude use of the non-US-licensed comparator product in a clinical study intended to support a demonstration of biosimilarity.”

This draft guidance does not exactly lead the way to a global comparator product, but it is progress toward that end. Also, one other note, we are still awaiting the final guidance from the FDA, officially removing the clinical efficacy study requirement.

Two Leaders’ Views on National PBM Reform: Biosimilar and ERISA Benefits

A summary of remarks on PBM reform and the FTC–ESI settlement by speakers at last month’s Association for Accessible Medicines’ Access 2026 conference.

The Association for Accessible Medicines’ (AAM) Access 2026 conference in Miami February 23-25 was perfectly timed to take advantage of perhaps the most important health care—related events of the year: the passage of the Consolidated Appropriation Act’s pharmacy benefit manager (PBM) reforms and the Federal Trade Commission (FTC) settlement with Express Scripts (ESI), which almost certainly will lead to agreements with the other big 3 PBMs. In two sessions at AAM, two main players in shaping PBM reform over several years discuss their reactions and expectations.

On the Long Road to PBM Rebate Changes With Scott Gottlieb

Scott Gottlieb, MD, former FDA Commissioner during the first Trump administration, was part of the effort to enact its Biosimilar Action Plan to nudge biosimilar uptake in the right direction. Another of the pro-biosimilar efforts by he and then Secretary of Health and Human Services Alex Azar was the planned removal of safe harbor protection for drug rebates. Though some of these efforts made it to the finish line, the use of drug rebates to ensure PBM profits and to disadvantage lower-priced pharmaceuticals survived their attempts. At the AAM conference in Miami last week, Dr. Gottlieb restated, “If there was ever PBM actions that can prove their anticompetitiveness, this is it!”

Scott Gottlieb believes additional PBM reform is unlikely, though we may not have gone far enough — Scott Gottlieb

Dr. Gottlieb believes that “you can take the entire construct we made, tailor it to just these circumstances today. The cost of implementing the rule [to remove the rebate safe harbor] will save money in this narrow biosimilar application.”

Lacking that, he still believes that the settlement between the FTC and ESI “was profound. The issues of the rebates flowing back to consumers, the writing’s on the wall. A lot of the changes are happening absent legislation action.” However, he believes that with the reforms achieved through the Consolidated Appropriations Act of 2026 and the FTC–ESI settlement, “additional PBM reform is unlikely, though we may not have gone far enough,” said Dr. Gottlieb. Still, he believes that CMS can take additional action, in the way it directs companies to design formularies.

ERISA Employers Can Celebrate Freer PBM Markets

A jubilant James Gelfand, JD, President and CEO, The ERISA Industry Committee (ERIC), exclaimed, “We won! We’ve forced transparency on the PBMs, forced pass-through rebates, and we’re ready to celebrate. This will make it very hard for PBMs to make money on arbitrage. We think it’s transformative.”

Mr. Gelfand noted that Congress is still considering additional changes, one of which is to address the request-for-proposal process. This is necessary because of the cozy relationship between the big PBMs and the employer benefit consultants and brokers. “If the PBMs are in cahoots with the brokerage/consulting companies to keep their business, it will make it very hard for these other PBMs to come in with innovative models and to apply fiduciary standards,” he said.

The PBMs have said that employers love rebates, according to Mr. Gelfand, saying they go to the company’s bottom line. ERISA rules prohibit this: “We can’t use the rebates for anything but to reduce healthcare costs.”

We’ve forced transparency on the PBMs, forced pass-through rebates — James Gelfand

After these reforms are applied, 98% of our employer members still see a role for PBMs, he said. “We don’t want to get into the PBM business.”

Free markets need competition, information, and choice. The rebate pass-through provision is the most important of the reforms. His organization, ERIC, has been advocating for PBMs for many years. Mr. Gelfand remarked, in the Consolidated Appropriations Act of 2021, “we got a provision in place that aimed at revealing the compensation of the vendors that work for employers in employer-sponsored health benefit plans. The Department of Labor interpreted that to mean just brokers and consultants. But from the beginning, we had intended this to also include PBMs. Legislators sent letters to the Department of Labor, telling them they forgot to include PBMs. It took another 5 years to get this changed.”

PBMs and Employer Benefit Consultants: Only a Minor Conflict of Interest?

Employers take advice from consultants and brokers, who help them choose their PBM. They help them decide whether they should be part of a purchasing collaborative, or whether they should contract directly with pharmaceutical companies. “Yet, these third parties are getting paid by the PBM, which makes it not very reliable advice,” asserted Mr. Gelfand. “And we have the same issue with the PBM who tells us, ‘Trust us, you want to go with the AbbVie drug, it’s been out for years, it’s reliable, and the rebate is awesome!’ If I ask them how much of a rebate they receive, they say, ‘We’re not going to tell you that. It’s not important.’”

The Department of Labor will have to unravel the gordian knot of how PBMs profit, opening the employer’s eyes to how PBMs are earning their money. “Employers pay 75 cents out of every health care dollar, so it’s a big deal if we’re being steered towards the higher-priced product. We’ve been ‘trusting’ the PBMs for decades that we’ve been getting the lowest net-cost drugs. But it can’t be explained to us exactly how it’s the lowest net-cost product.”

Instead, the PBM responds, “You have to look across the entire book of business, because having this drug and its bundled rebate is complicated and can’t be easily explained to you.” Mr. Gelfand believes it may be 18 months before a final rule is released by the Department of Labor, but “all that is going to be over.”

We can’t effectively legislate against specific behaviors of the PBM (like spread pricing or rebates) because of the time it takes to pass a Congressional proposal. “The PBMs have very smart people and will always be a step ahead of us, and maybe three steps ahead of Congress because they are so slow to act,” said Mr. Gelfand. “Fundamentally, you can’t just keep going after these rifle shots to legislate their behavior. You must legislate a new business model or paradigm, or they will find ways to get around it. That’s why we think PBMs should be fiduciaries. As a fiduciary, you cannot just invent new ways to cheat your customer. Under ERISA, fiduciaries cannot waste money under the plan, and they must make decisions that are prudent and in the best interests of the beneficiaries of that plan. There’s no way to fit these nasty arbitrage tricks under these two rules. Unfortunately, we’re probably years away from getting this done.”

This article was written by our Director of Content, Stanton Mehr. Stan is 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.

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