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.

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.

Trump Tariffs on Generics and Biosimilars: Utter Nonsense or Just Plain Stupidity?

Trump’s desire to remove a drug tariff exemption for generics and biosimilars produced overseas is ill-conceived and truly damaging to these low-margin industries.

The Trump administration seems to think that making generics and biosimilars more expensive to the health system and consumers alike is a great idea.

On July 21, President Trump posted on social media that he intends to remove an exemption for generic drug makers from pharmaceutical tariffs and place a 100% tariff on these products in 2028. The Trump tariff would rise to 200% if manufacturers do not start producing these drugs on US soil by 2029. The Administration’s definition of generic drugs includes any nonbranded products, and biosimilars are therefore part of this category.

The Supreme Court ruled that the administration cannot legally usurp Congress’s authority to apply taxes or tariffs for arbitrary purposes. This action would not only be arbitrary but damaging to the very foundation of the biosimilar and generic industries.

The reason for the existence of generics and biosimilars is to provide lower cost pharmaceuticals to patients, payers, and the health system in general. The basis for lower costs for generics and biosimilars is competition, not decree. If a legitimate business case could be identified to support the implementation of these Trump tariffs, a portion—if not all—would be passed onto payers and consumers, thus raising the net price of generics and biosimilars. The administration seems to ignore this basic business practice.

Generic Drug Margins Already Extremely Low

We have reported that the generic manufacturing industry suffers from low margins, which have reduced production and contributed to drug shortages in the US. A substantial tariff on these medications will initiate discussions in the boardroom as to whether their falling profit margins justify the building of US-based facilities just to avoid the additional tariff costs. Some, if not many, manufacturers will answer this question negatively.

Cutting Into Biosimilar Development

On the biosimilar side, where margins are greater but revenues may still be lower than expected for some biologics, the Trump tariff will counter some of the legislative proposals intended to streamline biosimilar development that are just now moving through Congress. Furthermore, the initiative will further threaten our ability to shrink the biosimilar void, and discourage future biosimilar development.

Removing an exemption for generics or biosimilars on a more general pharmaceutical tariff is ill-conceived and short-sighted. Certainly, no Congress that is actively trying to amplify biosimilar competition and reduce development costs would agree that tariffs of this nature justify the risks.

This is a terrible idea, and it might be further evidence that someone needs to monitor the president’s social media posts before they are sent.

In Other Biosimilar News

A real-world postmarketing study of Samsung Bioepis and Harrow’s Byooviz confirmed its associated clinical outcomes were equivalent to those of the reference product Lucentis, according to Korean researchers.

Interim results of this open-label observational study were presented at the annual meeting of the American Society of Retinal Specialists, July 15–18, in Montreal. The interim data reported results on 298 patients treated from May 2022 to May 2026. One hundred eighty-two participants did not have previous VEGF inhibitor treatment, and 116 were switched from the reference product. After 24 weeks of treatment, Byooviz’s efficacy, in terms of best-corrected visual acuity and central subfield thickness, was not significantly different than Lucentis, without new safety concerns. Although the efficacy results of this comparative study were unsurprising, the study’s authors also pointed out that disease duration prior to treatment was significantly related to worse outcomes, supporting that the earlier the treatment, the better chance for visual improvement (regardless of ranibizumab product used).

Another Big 3 PBM Settles With FTC on Rebates, Passthroughs, and Price Spreads

The Federal Trade Commission has reached a tentative settlement with the Big 3 PBM Caremark, which should increase the PBM’s transparency and has the potential for further reducing the use of rebate-based pharmaceutical pricing models.

In the latest salvo in the Federal Trade Commission’s (FTC’s) war on PBM practices, begun in 2024, it has reached a tentative settlement with CVS Health’s subsidiary Caremark, which should increase the pharmacy benefit manager’s (PBM’s) transparency and has the potential for further reducing the use of rebate-based pharmaceutical pricing models.

Announced on July 14, this is the second settlement with a Big 3 PBM formally announced by the FTC. A previous agreement with Express Scripts was reached in February, and the FTC stated in its press release that it is in active negotiations with OptumRx for a similar type of settlement.

TrumpRx Purchases to Count Towards Drug Deductibles

One of the interesting aspects of the settlement is the agreement by Caremark to incorporate purchases through TrumpRx under insureds’ pharmacy benefit—it will be counted toward drug deductible expenditures, as a standard offering to plan sponsors. These purchases would also be counted towards out-of-pocket maximums.

In addition, under the consent order, Caremark will be required to:

Cease discriminating against low wholesale acquisition cost (WAC) versions of a drug on its standard formularies
Provide a standard offering to plan sponsors that ensures that rebates will be passed through to members at the point of sale and that members’ out-of-pocket costs are no longer higher than the net cost to plan sponsors
Provide a standard offering to all plan sponsors that allows the plan sponsor to transition off rebate guarantees and spread pricing
Increase transparency for plan sponsors, assumedly through more frequent and comprehensive reporting
Separate the fees paid by drug manufacturers to PBMs or GPOs from list prices in its standard offering
Stop interfering with the ability of pharmacies in its networks to work with pharmacy hub service providers

These FTC agreements appear to be a valuable advantage for future biosimilars offered under the pharmacy benefit. Without a rebate-based reimbursement advantage, PBMs will have less incentive to retain reference products on their drug formulary, which opens the door to earlier access (and preference) of biosimilar agents.

Impact on Private-Label Arrangements for Biosimilars

It may also shed more light on private-label arrangements and pricing, through the transparency provision. Perhaps, the agreement will even inhibit the practice, through the provision prohibiting discrimination against low-WAC agents.

In these private-label arrangements, the biosimilars sold through the PBM distributor (in CVS’s case, Cordavis) are often substantially higher than other biosimilar brands, so that the PBM can profit from the price spread.

As a result, manufacturers of adalimumab and ustekinumab biosimilars, for example, have had to compete against their own private-label versions for market share. More importantly, it closed the access window on the fingers of manufacturers who did not reach private-label agreements, as these PBMs control more than 80% of the US prescription market, discouraging new biosimilar development.

There was no mention in the agreement about Caremark serving as a fiduciary to its clients, however, which would have further spotlighted the conflict of interest represented by these private-label arrangements.

According to the FTC, these terms are very similar to the terms reached in the settlement with Express Scripts earlier this year. The consent agreement is not finalized until a public comment of 30 days has elapsed.

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?

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.

CVS Caremark Drops Stelara Coverage in Favor of Biosimilars

CVS Caremark announced that after June 30, it will no longer cover Stelara for most commercial clients and instead cover two ustekinumab biosimilars, including its private-label version of Pyzchiva.

Effective with its July 1, 2026 formulary update, CVS Caremark will officially drop from coverage the ustekinumab reference product Stelara and prefer both Pyzchiva and Yesintek biosimilars. This change applies to “its most common commercial template formularies.”

CVS Caremark clarified to BR&R that its Cordavis private-label version of Samsung Bioepis’ Pyzchiva would be preferred, as well as the original branded Yesintek from Biocon, and not the original branded version of Pyzchiva.

Pyzchiva’s wholesale acquisition cost (WAC) (both he branded and private-label version) is 85%–86% below the original WAC price of Stelara (which is now available at a 75% discount). CVS Caremark stated that there will be $0 consumer cost sharing when either of the two preferred biosimilars are prescribed.

Joshua Fredell, PharmD, Senior Vice President, CVS Health, said, “Expanding adoption of FDA approved biosimilars allows us to deliver significant savings for clients while supporting broader, more affordable access to proven therapies.”

In addition, CVS Caremark noted that the biosimilars Tyruko (reference product, Tysabri) and Epysqli (reference product, Soliris) will also be covered. CVS did not disclose that these two reference products would be excluded from coverage, however. Unlike ustekinumab, natalizumab and eculizumab, are most commonly covered under the medical benefit.

Will We Remember Marty Makary in 2030?

For the biosimilar industry, serious progress was made in streamlining biosimilar development, but little was finalized, under the leadership of now-former FDA Commissioner Dr. Marty Makary.

With the resignation on May 12th of Marty Makary, MD, MPH, as FDA Commissioner, it is difficult to analyze his performance after a scant 13 months in office. For instance, the FDA suffered massive staff cuts under the auspices of Elon Musk’s DOGE and was forced to hire back many of the same people.

FDA Commissioner Marty Makary — Former FDA Commissioner Dr. Marty Makary

Meetings of FDA’s Advisory Committees have been few and far between. This essentially wiped out the public’s ability to comment directly to scientists at the time of their votes for recommending or denying a particular drug approval. In fact, several of the FDA Advisory Committees no longer meet at all; only four meetings were scheduled to occur this year through the end of this month.

A Legacy of Advancing Biosimilar Development?

The FDA under Dr. Makary seemed eager to move forward to streamline biosimilar development, but this has not yet resulted in finalized regulatory policy. It is true that under his watch, the FDA issued its draft guidance on the removal of the mandate for phase 3 trials in biosimilar development, but 7 months later, no finalized guidance has been issued. During this time, the FDA has seemingly implemented this rule in any case, and as reported earlier in 2026, several biosimilar manufacturers have acted upon it, by terminating active phase 3 investigations.

In addition, we still have no official policy that nullifies or overrides the infamous interchangeability designation, despite FDA’s expressed opinion that it should be applied to any approved biosimilar, and holding a workshop on the issue last September.

In March, a draft guidance was released on removing the need for bridging studies when non-US licensed reference products are used for pharmacokinetic studies. The timing of the finalized document (after a public comment period) is up in the air, and may be further delayed without an official FDA Commissioner in office.

At certain points, he seemed to embrace the chaos at HHS and at others he tried to tamp down fires caused by the administration. In the end, his decision to fight industry interests in their promotion of flavored E-cigarettes may have been his undoing. However, it seems unlikely that anyone can truly make a lasting impression at FDA after only 13 months.

Overall, a statement he made at last October’s GRx+Biosims meeting sums up his legacy: “I think that we can unite in this country by focusing around health.” It demonstrated either the impossible challenge he faced in the administration or extreme obliviousness regarding the serious attacks on US public health by his boss at Health and Human Services.

Biosimilar Company Acquisitions: Amneal and Sun in Separate Deals Signal More Generic Drug Maker Participation

Amneal has gone from purchasing a subsidiary to acquiring 100% of Kashiv Biosciences, LLC; and India-based generic drug maker Sun Pharmaceuticals is acquiring Organon.

Amneal Pharmaceuticals to Buy Kashiv Biosciences for $1.1 Billion

Over the past couple of years, Kashiv Biosciences, LLC has served as an R&D engine for Amneal Pharmaceuticals’ biosimilar commercialization business. Whereas Amneal had previously purchased a subsidiary of Kashiv (Kashiv Specialty Pharmaceuticals) in 2021, it announced on April 22 that it intends to purchase 100% of the parent company.

According to Chirag Patel, Co-Founder and Co-Chief Executive Officer of Amneal, “With Kashiv, Amneal becomes a fully integrated global biosimilars leader at the forefront of the next wave of U.S. affordable medicines. This acquisition is a natural next step in our strategy to build a leading, diversified biopharmaceutical company, and we are confident it will drive accelerated growth and long-term value creation.”

As part of the deal, Amneal will obtain two US production plants and two India-based production facilities.

The $1.1 billion transaction includes $375 million in cash at closing, along with $375 million of equity. Kashiv will also receive up to $350 million in potential payments upon attaining specific regulatory milestones, in addition to royalties on its products. Amneal expects that the acquisition will close before the end of 2026.

Organon to Be Sold to Sun Pharma for $11.75 Billion

Sun Pharmaceutical Industries officially entered the biosimilar market, by announcing its $11.75 billion acquisition of Organon. Organon was spun off from Merck in 2021, and focused on both biosimilar commercialization and the sales of other branded pharmaceuticals, including women’s health products. Mumbai-based Sun Pharma is India’s largest generic pharmaceutical manufacturer.

Under the transaction, Organon will be merged with the parent company’s Sun Pharma subsidiary. The transaction should close in early 2027.

In statements made in Sun’s press release, it is unclear what value Sun places on the biosimilar part of Organon’s business. However, the move does position Sun as a global biosimilar player, with a presence in 150 countries. Will Sun leverage Organon’s position as a biosimilar commercialization partner and contract with other manufacturers and/or will Sun move into the biosimilar R&D game as well?

Biosimilars as a Natural Evolution for Generic Manufacturers

The moves by Amneal and Sun may presage moves by other generic drug makers to expand their horizons. As we’ve seen and heard at the recent meetings and at IQVIA presentations, the generic drug industry is at a crossroads—profits are being squeezed out and generic drug launches are slowing to a trickle. Scott Biggs of IQVIA stated at the Association of Accessible Medicines Access! Meeting earlier this year, “In 2018, it took seven branded drugs to equal the total revenues of the generic business; today, it only takes two.”

Generic company sustainability is certainly an issue, and the biosimilar field seems a natural expansion for these companies. This is especially true as efforts to streamline the biosimilar development process significantly lowers the costs of entry.

Although a few biosimilar manufacturers have found handsome profits in the biosimilar industry, many find only limited revenues for several products, including those with small market shares of adalimumab, pegfilgrastim, ranibizumab, infliximab, and others. However, $50 million in annual revenues for an individual biosimilar may be acceptable to a generics company with 50 other products in their portfolio. Ask generic manufacturers like Biocon, Amneal, and Dr. Reddy’s.

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.

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