Sandoz to Market Samsung Bioepis’ Ustekinumab Biosimilar

Samsung Bioepis announced this week that it had signed a commercialization agreement with Sandoz regarding their investigational biosimilar ustekinumab candidate SB17. This is Samsung Bioepis’ first marketing agreement with Sandoz; the company has marketing agreements in place with Organon for  Renflexis® (infliximab), Hadlima® (adalimumab), and Ontruzant® (trastuzumab); and with Biogen for Byooviz®.

In response to our question as to whether this agreement may signal a more extensive partnership with Sandoz, a spokesperson from Samsung Bioepis Emailed the following statement: “We have always sought, and will seek the most optimal option that allows access to our biosimilars for patients who are in need of medicines, and while it has been through commercial partnerships for most of our products, it does not mean that we will always be considering commercial partnerships for future products or for other regions which do not fall under commercial partnerships. Our long-term goal has been, and will always be, to become a fully integrated global pharmaceutical company with end-to-end capabilities from pre-clinical development to commercialization.”

Even though Samsung Bioepis harbors hopes of one day marketing their own products, the agreement seems to be a particularly good fit for Sandoz: It is one of the few major biosimilar manufacturers that did not already have a Stelara® biosimilar under development. Under the terms of the arrangement, Sandoz will have commercialization rights for the product, once approved, in Europe and North America.

The phase 3 clinical trial for SB17 was completed in 2022, and a 351(k) filing may be expected in the near future, allowing Samsung to join Celltrion, Alvotech, and perhaps Formycon in the first wave of ustekinumab biosimilar applications. There may be as many as eight biosimilar competitors for this agent.

Sandoz has been quite active in the headlines recently, with the announcement as supplier of an adalimumab biosimilar to CVS Health’s Cordavis, the FDA approval of Tyruko® for the treatment of multiple sclerosis and Crohn’s disease, and its anticipated spin-off from Novartis, which is to occur “on or around October 4, 2023.”

Outlook Therapeutics Gets FDA Rejection on Its Ophthalmologic Bevacizumab Formulation

The quest for a manufactured ophthalmologic version of bevacizumab continues. The use of compounded bevacizumab has been considered a low-cost alternative to ranibizumab for the treatment of wet age-related macular degeneration (AMD). This may comprise up to half of the wet AMD utilization.

Outlook Therapeutics, which has sought to bring its ONS-5010 product to market, announced that it received a complete response letter (CRL) from the FDA. In a press release, the manufacturer acknowledged “several [chemistry manufacturing and control] issues, observations from preapproval manufacturing inspections, and a lack of substantial evidence.”

Outlook Therapeutics believes all of the issues raised by the CRL on ONS-5010 are addressable, and it is seeking a Type A meeting with the FDA for more clarification, especially regarding the need for any additional clinical evidence. Outlook had submitted data on three clinical trials, and the FDA acknowledged that the NORSE TWO pivotal trial met its safety and efficacy endpoints.

Outlook anticipates ONS-5010 will compete with Lucentis® and the ranibizumab biosimilars (Byooviz®, Cimerli®). In the short term though, Outlook’s stock price lost nearly 80% of its value, to $0.27 per share, based on this news.  

Two More Patent Settlements and Launch Dates for Ustekinumab Biosimilars

In early August, partners Fresenius Kabi and Formycon announced that they had reached an agreement with Johnson & Johnson to launch FYB202, if approved by the FDA, “no later than April 15, 2025.” Later that month, Celltrion finalized its patent agreement for CT-P43, enabling a launch in March 2025. Celltrion had filed its 351(k) application for FDA approval in June 2023.

ManufacturerDrugSettlement Launch Dates (“no later than”)
AmgenABP 654Jan 1, 2025
Alvotech/TevaAVT04Feb 21, 2025
CelltrionCT-P43March 7, 2025
Fresenius Kabi/FormyconFYB202April 15, 2025

The principal patent for the reference product expires next month in the US (and in July 2024 in the EU). It is assumed that these ustekinumab biosimilar launch agreements also end all patent disputes among the parties. It is not known whether royalties are to be paid to Johnson & Johnson based on biosimilar sales, as were included in the AbbVie agreements for Humira®.

Other publicly announced, potential competitors for this interleukin 12/23 biologic include Bio-Thera, Samsung Bioepis, and Biocon, all of which have completed or are finishing their phase 3 studies. Similar to the Humira example, we expect all to eventually sign settlements with Johnson & Johnson prior to launch.    

Curiously, all of the ustekinumab biosimilar launch settlements signed to date include the language “no later than XX, 2023.” This begs the question as to what may pose an opportunity to launch earlier? This occurred when several of the adalimumab biosimilars were able to move their launch dates to July from the third and fourth quarters of 2023.

Three Biosimilar Targets in CMS’s Sights

With the announcement today of the first 10 drugs to be subject to the Medicare price negotiation provisions of the Inflation Reduction Act, three of these agents are of interest to the biosimilar community—Enbrel®, Stelara®, and NovoLog®.

With the initial implementation date of the newly “negotiated” prices set for January 1, 2026, it is likely that Johnson & Johnson will bypass price negotiation, via the Biosimilar Special Rule, as Stelara (ustekinumab) should be facing active biosimilar competition in 2025. Based on the number of biosimilar competitors for Stelara, the net price to payers should drop rapidly for all customers (not just Medicare).

On the other hand, Amgen’s Enbrel (etanercept) has been shielded from biosimilar competition for far too long (and may not face biosimilar competition until 2029, or 3 decades of exclusivity). For this product, Medicare price negotiation cannot come quickly enough. If CMS follows through with mandatory discounts between 25% and 60%, depending on how long the drug has been on the market, then Amgen should expect very sharp cuts. This may well further discourage biosimilar manufacturers who already received approval (and long ago) for their etanercept products from entering the market at all in 2029. This includes Sandoz’s Erelzi™ and Samsung Bioepis’ Eticovo™. CMS will release the amount it will pay for these first 10 drugs in September 2024, which should at least avert further list price increases of Enbrel.

NovoLog (insulin aspart) is also the subject of development by biosimilar manufacturers, including CivicaRx and  Biocon. As multiple insulin manufacturers and CivicaRx have pledged to offer their products to patients for no more than $30 per month, it is unknown at this time how Medicare price negotiation may affect CMS’s insulin costs.

What is Cordavis and Why Will It Be Important to CVS Health and Biosimilars?

On Wednesday August 23rd, CVS Health released information regarding an agreement with Sandoz, which will start its new venture called Cordavis in 2024. The fact that this agreement centers around Sandoz’s adalimumab biosimilar Hyrimoz® raises questions regarding the strategy and potential value of this option.

Sandoz introduced Hyrimoz in July of this year with both a high WAC and a low WAC cost option. The latter is available at an 81% discount from WAC in an unbranded product. The CVS Health announcement specifies that Sandoz will make a private label version of this low-WAC option available for its own commercialization. This brings to mind the deal between Coherus Biosciences and Mark Cuban’s Cost Plus Drug Company to market that particular adalimumab biosimilar (at 92% below the WAC price). The Cordavis announcement t also makes me consider the CivicaRx initiative, which seeks to manufacturer and distribute insulin biosimilars and other important pharmaceuticals at great discount.

CVS Health was the subject of separate news last week, in which Blue Shield of California announced that it was stripping some responsibilities from the pharmacy benefit manager (PBM) and handing them off to other partners. Notably, this did not include price and contract negotiations for specialty drugs, including biologics and biosimilars, which is one of the dominant cost centers for the health plan. And we should also mention the nearly constant pressure being exerted by Congress on the PBM industry to prove value other than rebate contracts.

Thus, it seems CVS Health, as well as other PBMs, are trying to evolve their business models. The press release from CVS Health announcing Cordavis and the Sandoz agreement (note: Sandoz did not issue a press release) stated that “Through Cordavis, CVS Health intends to develop a portfolio of products that it expects will facilitate broader access to biosimilars in the US—creating more competition that drives down prices—while encouraging investment in future products.” There are currently 9 adalimumab compounds marketed, with various formulations and pricing structures. It is unclear what CVS Health believes will be achieved with number 10, which will be introduced in 2024.

In one respect at least, the agreement may make sense for Sandoz. In its battle for marketshare and coverage of its adalimumab biosimilar (Hyrimoz and its unbranded version), a relationship of this type could have potential upside. It might also create a durable channel through which future pharmacy benefit biosimilars, like ustekinumab, can be covered.  

However, the competitive pricing of Sandoz’s adalimumab biosimilar could be mostly a nonissue. According to the press release, the list price will be “more than 80% lower than the current list price of Humira.” That discount is already offered by Sandoz, Samsung Bioepis/Organon, and Coherus (though in low-concentration form only), and it likely will be offered by others before the beginning of 2024. Amgen’s initial 55% WAC discount may also need to be increased to match these existing reductions.

In the press release, Shawn Guertin, CFO of CVS Health stated, “Cordavis is a logical evolution for us and will help ensure sufficient supply of biosimilars in the US and support this market now and in the future, while ultimately improving health outcomes and reducing costs for consumers.” Whereas maintaining biosimilar supply has been voiced as an important consideration, payers don’t generally believe this is a serious concern with Sandoz. Perhaps the concern reflects some of the thinking behind the CivicaRx venture, where CVS Health believes that there will be widespread attrition in the market, which could lead to a dearth of biosimilar suppliers. In that case, ensuring an adequate biosimilar supply might be viewed as a new function of the PBM. That would indeed be novel.

I haven’t yet fully grasped the implications of this CVS Health-Sandoz arrangement. Neither CVS Health and Sandoz have responded to requests for comment by the time of publication. If there is a more strategic intent lurking behind the language, I’m not aware of it (yet).

Sandoz Notches Approval of Tyruko, First Biosimilar to Treat Multiple Sclerosis

On August 24, the FDA announced that it had approved its 42nd biosimilar—Sandoz’s Tyruko® (natalizumab-sztn), a new biosimilar agent for the treatment of relapsing forms of multiple sclerosis (MS) (an initial clinically isolated occurrence, relapsing-remitting disease, and secondary progressive disease). As with the reference product Tysabri®, Tyruko is also indicated to induce and maintain clinical response in patients with moderate-to-severe Crohn’s disease who have had inadequate response to or are unable to tolerate other conventional treatments. Phase 3 studies were completed in patients with relapsing-remitting multiple sclerosis.

This approval marks several new biosimilar firsts. It is the first integrin-receptor antagonist, as well as the first biosimilar approval for an MS treatment. This will also be the first opportunity for neurologists to prescribe a biosimilar product.

In addition, Biogen’s Tysabri earned $1.1 billion in 2022, but it has only 5% of the total marketshare in the MS category owing to heavy competition and Roche’s leading product Ocrevus®. Another factor limiting utilization of natalizumab is the boxed warning for the increased risk of progressive multifocal leukoencephalopathy, which Tyruko also carries. Therefore, it is also the first US biosimilar entry for a reference product that does not lead the disease category (e.g., infliximab, trastuzumab, bevacizumab, adalimumab, pegfilgrastim, etc).

Launch and pricing information have not been announced yet by Sandoz, which is in the final stages of a spinoff from Novartis. The savings gained from this product may be more limited than we have seen from biosimilar introductions in the past: No other major biosimilar manufacturer has publicly announced its intent to enter this competition. As previously reported, patent litigation between Sandoz and Biogen is outstanding and may affect launch timing. In its own press release, the company stated, “Sandoz is committed to bringing this important medicine to US patients as soon as possible.”

Tyruko was developed by Sandoz’s partner Polpharma Biologics. Sandoz’s biosimilar portfolio now stands at 5 approved products, including adalimumab (Hyrimoz®), filgrastim (Zarxio®), pegfilgrastim (Ziextenzo®), Tyruko, and etanercept (Erelzi®).  

Simplifying Biosimilar Development to Ensure Long-Term Competition

I’m not sure if you saw it, but leading biosimilar industry scientists/advocates published in BioDrugs an exemplary summary of the steps regulators may take now to expand the biosimilar pipeline tomorrow. Importantly, these steps are not recommended to improve profits but because the regulatory science and biosimilar experience fully supports it.

Food and Drug Administration

The article, written by Hillel Cohen, Matthew Turner, Dorothy McCabe, and Gillian Woollett, and colleagues from Sandoz, Fresenius Kabi, Boehringer Ingelheim, and Samsung Bioepis, respectively, offered a strong argument for significantly lowering the bar on clinical studies and costs to biosimilar development, by following specific steps (some of which are already under consideration by the FDA). I’ve summarized a few of their important points below.

Mandate Comparative Efficacy Studies on a Case-by-Case Basis Only

Momentum has been gaining to deemphasize large-scale clinical studies in favor of analytical and structural evaluation of biosimilars. The FDA has acknowledged that the totality of evidence approach for biosimilar approval does not rely heavily on late-stage clinical trials. The authors write, “A review from 2019 revealed that no biosimilar found to be highly similar to their reference product in analytical and [pharmacokinetic] studies subsequently failed to obtain approval due to failed equivalence observed in a clinical efficacy study.”

Furthermore, these “noninferiority studies” generally lack sufficient statistical power to provide meaningful results. The authors suggest that FDA specify the need for these studies in cases where there is residual uncertainty as to the outcome. Currently, biosimilar manufacturers undertake these expensive phase 3 investigations to cover all their bases, which drives up the cost of development. They will continue to do so until regulators clarify early in the course of a development program when this is actually required.

Move Beyond Immunogenicity

The preponderance of real-world evidence, based on approximately 5 billion patient-days of therapy with biosimilars in the US and EU, has not yielded any important differences in immunogenicity resulting in adverse events or lack of efficacy relative to the reference products. “Based on these observations, the EMA and Heads of Medicines Agencies (Europe) issued joint statement in 2022 supporting the safety, efficacy, and immunogenicity of both single and multiple switches among reference products and biosimilars, and in 2023, the FDA provided similar support in a presentation to [healthcare practitioners],” according to the authors.

And far more evidence will accumulate in the US as patients taking Humira® are eventually switched to adalimumab biosimilars and then among the biosimilars. Although immunogenicity was an early concern of regulators, this has not proven to be an important barrier to biosimilar approval and utilization. Cohen and colleagues suggest that “immunogenicity analysis for biosimilars be moved to a risk-based consideration as opposed to a global and routine requirement.”

Reconsider the Interchangeability Designation

My opinion is “dump it ASAP.” The designation has quickly outlived its apparent utility, and it is a legal designation but not a scientifically based one. The sole purpose of the interchangeability assignment was to provide a mechanism by which biosimilar products could be automatically substituted at retail or specialty pharmacies. However, the conduct of multiple switching studies (which has not been consistently applied by the FDA), which were to instill confidence in the therapeutic equivalence of these products, has not revealed any immunogenicity differences and has instead sowed confusion as to (1) the relative quality of the products and (2) whether interchangeability applies across all product formulations.

The authors write, “As a scientific matter, we support immediate reconsideration of the requirements for US interchangeability and future elimination of this category. All biosimilars are, by definition, of the same quality as interchangeable biologics, and in practical terms, all biosimilars are interchangeable for the purposes of physician prescribing practices.” In essence, the public has to believe this simple statement about all biosimilars, as they would about any AB-rated generic medication: A biosimilar therapy can be substituted for another biologic in the same category to gain the same clinical outcomes.

Assume no Important Differences Between US and EU Reference Biologics

Although local biosimilar regulations require that pharmacokinetic comparison studies be performed against the locally available reference biologic, there is little justification for this mandate. The authors make the case that the same reference biologic produced in the EU and US are subject to bridging studies that assure that any manufacturing process changes do not result in important structural changes or differences in clinical outcomes. “To repeat bridging studies between foreign and locally sourced reference products for each subsequent jurisdiction offers no new scientific or clinical information,” state the authors. “Such studies significantly inflate the cost and delay biosimilar development and make some markets unviable, limiting patient access in those regions, and so should be eliminated.”

This recommendation also implies the possibility for the use of a single global standard for analytical, structural, and other testing. This could greatly reduce the cost of developers’ obtaining reference biologic samples, especially if there are large price differences country to country.

I’ve highlighted some of their recommendations here, but the gist of the argument is that the cost of biosimilar development can be reduced substantially. This will help ensure that both major biopharmaceutical firms and generic manufacturers will continue to introduce new biosimilar candidates in the future. This will be essential to managing the costs of specialty pharmaceuticals in the near term and to support our ability to afford innovative (i.e., expensive) therapies in the future.

Where’s Pfizer’s Adalimumab Biosimilar?

In the mass of adalimumab launches in July, it may be tough to spot the one missing player. This is not a game of Where’s Waldo? but rather, where’s Pfizer’s Abrilada™? Well, that’s a good question. Of the competitors that have gained FDA approval, they are the only manufacturer that did not launch its product last month.

I listened to Pfizer’s second-quarter earnings call on August 1 to see if the executive team would provide any updates. Unsurprisingly, the call focused on its COVID-19 treatments and vaccines, which had provided a “shot in the arm” (sorry!) to the company’s bottom line for the last couple of years but whose continued contributions are expected to wane. Their second-quarter revenues were down more than 50% from the second quarter of 2022, largely due to COVID-19 trends. They did address other pipeline pharmaceuticals to some extent. However, there was no official mention of Abrilada’s launch, and during the Q&A phase, none of the queries addressed Pfizer’s biosimilar performance or commitment.

In the originally announced adalimumab biosimilar launch sequence, resulting from licensing agreements signed with AbbVie, Pfizer was to market Abrilada towards the back of the pack—in November 2023. However, the launch timing was radically changed with the signing of later agreements by newer competitors. This moved all second half launches up to July.  

Status of Abrilada’s Interchangeability Designation

Somewhat conspicuously, Pfizer did not publish an announcement of its anticipated Abrilada launch in early July (or of its pricing). The company had filed a supplemental biosimilar licensing application with the FDA for the interchangeability designation for its high-concentration formula on February 25, 2022. Although no official notification has been provided, any delay in the interchangeability approval does not seem to be related to data issues. According to Steven L. Danehy, Pfizer’s Director of Global Media Relations, “The FDA completed its review of Pfizer’s application in the fourth quarter of 2022 and provisionally determined that Abrilada (adalimumab-afzb) met the standards as an interchangeable biosimilar to Humira® (adalimumab).”

He stated in an Email to BR&R, “The FDA has not provided a timeframe for the anticipated approval of the interchangeable designation, but Pfizer is continuing to work with the agency to understand its perspective in the context of its guidance on interchangeability and determine a path forward.”

In the meantime, Mr. Danehy did confirm that the company plans to launch Abrilada as a “citrate-free biosimilar to Humira late third quarter/early fourth quarter 2023.” It is possible that Pfizer is still formulating its launch plan based on the current discounts being offered by the competition or that confusion over Abrilada’s interchangeability status (or applicability or exclusivity) is causing the delay.

Still a Formidable Roster of Biosimilars

Pfizer’s biosimilars may not be major items on its asset sheet but they are still contributors to the bottom line, especially on the oncology side. Retacrit®’s (epoetin alfa) US revenues totaled $68 million for the second quarter (a decrease of 21%), and US sales accounted for more than three-quarters of Retacrit revenues globally. It remains the only epoetin biosimilar marketed in the US, which has prevented a precipitous drop in the net price of the product.

Ruxience® (rituximab) pulled in $84 million during this period, a decline of 18%; Zirabev® (bevacizumab) (dropped 25% to $74 million; and Trazimera® (trastuzumab) contributed only $12 million, a reduction of 48%.

Pay less attention to the decreases in revenues; this is what should happen in biosimilar-dominated categories that have been the subject of fierce competition over the past few years. They are not signs that Pfizer missed an opportunity.

Pfizer’s other marketed immunology biosimilar is the result of its collaboration with Celltrion—Inflectra®. Inflectra’s US revenues are “down 81%,” according to Pfizer, “primarily driven by lower net price as a result of unfavorable changes in channel mix.” In the second quarter, Inflectra (infliximab) pulled in $15 million in revenue in the US, but still $74 million globally (this too was down, by 46% over the same quarter in 2022). And the picture could be cloudier for this product, as Celltrion hopes to introduce its subcutaneous formulation of infliximab soon.

The revenues for Nyvestim®, its filgrastim biosimilar, and Nyvepria®, its pegfilgrastim biosimilar, were not broken out separately, likely because they did not reach a reporting threshold. According to sources, Nyvepria holds less than a 10% marketshare, as the net price of the category is down 70% over time. Nyvestim’s has 17% of the marketshare, with a similar decline in net prices.

Pfizer doesn’t list any new biosimilar research and development as part of its pipeline, but that may not be the full story. It signed a contract manufacturing deal with Samsung Biologics, in which Samsung will produce Pfizer’s biologics and biosimilars. Does this signal a step back from biosimilar development for Pfizer? Mr. Danehy stated, “Pfizer is a global leader in biosimilars, and we plan to leverage our in-depth commercial experience with both biosimilars and innovative products to continue to meet the needs of patients and healthcare professionals.”  

Ranibizumab Biosimilar Updates: A Nascent Market but Limited Competition

Ranibizumab (Lucentis®) was the first opportunity for biosimilar manufacturers in the lucrative ophthalmology market. Not withstanding the potential launches of biosimilars for market-leader aflibercept (Eylea®), which holds the greatest marketshare, and the performance of other biobetters or brands (Vabysmo®, Susvimo®), some early ranibizumab biosimilar uptake is occurring. However, a third competitor, which may be crucial for lowering net prices more quickly, seems unlikely before this time next year.  

Coherus Biosciences reported its second-quarter earnings, which focused heavily on the early performance of its biosimilar Cimerli®. The company believes that Cimerli will ring up $100 million in net revenues by end of 2023, based on $26.7 million of business for the second quarter.

Cimerli was designated by the FDA as interchangeable with Lucentis, but this is primarily a buy-and-bill medication with very limited specialty pharmacy distribution. Therefore, an interchangeable designation may not have significant impact on utilization.

According to Samsung Bioepis’ Biosimilar Market Report (which includes data from the first quarter of 2023), market shares of Cimerli and Samsung’s own biosimilar product Byooviz® were 4% apiece (this was up from a negligible share for Cimerli in the fourth quarter of 2022 and static for Byooviz at 4% in that quarter). The new competition has resulted in an 11% reduction in average sales price for all ranibizumab products since the initial biosimilar launch of Byooviz in the third quarter of 2022.

With only the two biosimilars currently launched, the net costs for this category may decline at or slightly below the historical average of 12% to 15% annual reductions seen across other biosimilars covered under the medical benefit. It may take the entrance of a third competitor to yield greater savings.

What of the third competitor? XBrane Biopharma announced on July 24 that it is now seeking a new partner for commercializing its biosimilar candidate Xlucane™ in the US. An agreement with Bausch + Lomb to market the agent was discontinued “by mutual consent.” XBrane and partner STADA Arzneimittel withdrew its initial 351(k) application for the investigational biosimilar in Q2 2022. They announced that a new biologic license application was filed in June 2023, with a BsUFA action date of April 21, 2024. Finding a new marketing partner experienced in the ophthalmology space may slow the introduction of this biosimilar, should XBrane gain FDA approval.

Lupin had estimated completion of its phase 3 trial for LUBT010 for October 2022, but no updates have been released on the results. Reliance Life Sciences was reported to have an investigational biosimilar in phase 3 trials, but this could not be confirmed through the company or through In other words, that third competitor will not arrive soon.

In Related Biosimilar News

Coherus also reported in its second-quarter earnings release that Udenyca® net revenues increased 21% in the second quarter compared with the first quarter of 2023 ($32 million vs. $26 million, respectively). This increase was driven by greater utilization, according to the company; marketshare of this pegfilgrastim biosimilar was 12.2%, which is higher than for the prior quarter, but well below the 20% uptake at its peak.

They hope their autoinjector introduction in June will help make inroads into this fierce competition, and it still plans to introduce its on-body injector to compete with Neulasta® OnPro®. before end of year. OnPro retains 42% of the market.

Projecting at Least 40% Lower 2023 Humira® Net Costs in US

With the reporting of AbbVie’s second-quarter earnings, we are getting a better understanding of the substantial savings accruing to the US health system as a result of biosimilar competition. AbbVie reported yesterday that net US revenues from Humira dropped 26% in the US for the six months ending June 30th to $6.4 billion. For the second quarter alone, this figure also fell 26%, to $3.4 billion. Keep in mind, these figures are net revenues, already accounting for discounts and rebates.

These declines were not the result of significantly lower utilization. Amjevita®, which was introduced at the end of January, has not been a good sales story for Amgen to date; Amgen earlier announced that Amjevita uptake has been meager for the first quarter and this was further reinforced by the company’s second-quarter earnings report on August 3, when it recorded only $19 million in additional revenues). As they were the only competition for Humira through the July 1 launch of the great wave of adalimumab biosimilars, the one-quarter drop in net revenue from Humira had to result from additional pricing discounts and rebates by AbbVie.

As we reported earlier, PBMs have placed their covered biosimilars at parity with Humira and have not disadvantaged the reference product; this was reconfirmed by Prime Therapeutics yesterday. Therefore, we should expect that Humira utilization will not decrease dramatically before the end of the year. However, if we extrapolate AbbVie’s second-quarter and 6-month results to the full year, Humira revenue would be around $13 billion (which would be a decrease of 40% from $21 billion in 2022). To the extent that biosimilar manufacturers (singularly or collectively) can pick up significant marketshare by year’s end, the amount of savings may be greater.

These data continue to raise alarm bells for the biosimilar industry, as the savings gained to date are not the result of biosimilar manufacturers gaining a foothold in the adalimumab market and earning a profit. It is solely the result of AbbVie having to match the competition’s price in order to retain its parity status. With the discounts put forward by many of the biosimilar adalimumab manufacturers, it will now be up to the PBMs and their clients to prefer biosimilars in 2024 to ensure the competition is here to stay.

(This post was modified Aug 3 to reflect Amgen’s second-quarter Amjevita earnings)