Tag: biosimilar news

Alvotech Submits First Entyvio Biosimilar Application to FDA

The first 351(k) application for a vedolizumab (Entyvio) biosimilar has been submitted by Alvotech. If approved, the biosimilar would be marketed by Teva. Alvotech also resubmitted biosimilar applications for golimumab and aflibercept.

On June 8, Alvotech announced that the FDA has accepted its biologic licensing application for AVT16, a biosimilar candidate for the reference drug Entyvio. This marks the first FDA 351(k) drug application for a vedolizumab biosimilar.

vedolizumab biosimilar, Entyvio biosimilar

In its press release, Joseph McClellan, Chief Operating Officer  of Alvotech, stated, “FDA acceptance of the BLA for AVT16 is another important step in advancing our mission to increase access to biologic medicines for patients worldwide. Our proposed interchangeable biosimilar to Entyvio builds on our experience in immunology and reflects the strength of our fully integrated development and manufacturing platform.”

Vedolizumab, an integrin-receptor antagonist, is currently approved to treat adults with moderate-to-severe ulcerative colitis and Crohn’s disease. The reference product is available in both intravenous infusion and subcutaneous injections.

Takeda’s US Entyvio net revenues were over $4 billion in 2024, but the biologic has been targeted for Medicare maximum fair price negotiation. The negotiated price will be implemented on January 1, 2028, unless biosimilar launch is imminent. The original drug patent is set to expire in 2026.

Intravenous Infusion vs. Subcutaneous Injection

AVT16 would be available only as an intravenous infusion. Alvotech’s biologic licensing application does not cover the subcutaneous injectable. A separate investigational product, AVT80, promises a biosimilar version of the prefilled syringe and autoinjector administration. Alvotech noted that the European Medicines Agency has received a marketing application for both AVT16 and AVT80. It is not clear whether Alvotech and its marketing partner Teva, intends to market these products under separate brand names if approved. The patent on the subcutaneous formulation may not expire until the 2030s, according to some sources, which may play into Alvotech’s decision to separate the FDA applications.

In Other Alvotech Biosimilar News  

In November 2025, Alvotech received complete response letters from the FDA on two products—its biosimilar versions of golimumab and aflibercept. On June 4, 2026, the biosimilar manufacturer revealed that it had resubmitted its 351(k) applications to the FDA for both products (AVT05 for golimumab and AVT06 for aflibercept). Alvotech noted that it expects an FDA decision within 6 months. The complete response letters cited production facility issues, and not data or clinical quality questions. The latest FDA surveillance inspection of the Reykjavik production facility was completed by May 11, according to the company.  

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.

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.    

Biosimilar prescribing by neurologists

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.

Biosimilar-to-Biosimilar Switching: The Data Say Its Fine

The question of interchangeability for biosimilars has haunted the US Food and Drug Administration since the promulgation of the Biologics Price Competition and Innovation Act of 2010. The FDA’s draft guidelines on interchangeability evolved very slowly, and the biosimilar industry had to work to (1) keep up with the guidelines as they gained clarity, (2) tirelessly wage war on misinformation as to what an interchangeable biosimilar actually represented, and (3) grasp the value of interchangeability as a for-profit enterprise and whether to charge forward with the necessary clinical trials.

In this column, we have often addressed the interchangeability designation, and how it may be perceived. Leaders in the industry, like Hillel P. Cohen, PhD, Executive Director, Scientific Affairs, Sandoz, have hammered home strong arguments that interchangeable biosimilars are not “better drugs” than their noninterchangeable brethren. They are simply subject to additional switching studies to confirm their clinical similarity to the reference product. That does not mean they are more similar to the reference product than a standard biosimilar.

At the 2021 DIA Biosimilars conference held virtually this week, Dr. Cohen restated logic that may be obvious but less often discussed: if two biosimilars are deemed highly similar to the same reference product, those two biosimilars, through the Law of Transitivity, should be highly similar to each other.

Though logical, the concept of biosimilar-to-biosimilar interchangeability is not acknowledged on a regulatory basis. However, the potential for biosimilar-to-biosimilar switching is undeniably real.

Biosimilar-to-Biosimilar Switching Likely to Occur

A large proportion of patients receiving chronic therapy with biologics will no doubt change health plans or insurers over time. This happens voluntarily (e.g., they may choose a lower-price plan from year to year) or involuntarily (i.e., their employer changes the plan offering from one year to the next). These plans utilize their own drug formularies. Considering the launch of perhaps eight adalimumab biosimilars in 2023, health plans will likely prefer different preferred adalimumab products, based on the contracting offers they receive or the characteristics of the biosimilar (e.g., citrate free, high-dose formulation, interchangeable). The same can be said for insulin products, infliximab, ranibizumab, and even chronically used oncology agents. Assuming that is the case, biosimilar-to-biosimilar switching may be somewhat common in 2025.

Is that an issue? Likely not, said Dr. Cohen. He believes that any immunogenicity concern is a hypothetical argument, “and no empiric evidence exists to support the concern. Furthermore, no data has been published to support immunogenicity on a mechanistic basis.” The biosimilar is highly similar not only in efficacy and safety but also with regard to immunogenicity.

What the Data Say

Most of the available data on biosimilar switching comes from Europe, where biosimilars have accumulated over 2 billion patient treatment-days of exposure. Countries adopt whichever biosimilar has the lowest price, based on tendering systems. This may mean that more than one biosimilar is accepted, and these tenders can change from year to year. The regulatory concept of interchangeability does not exist in the EU, and switching may occur in both infusible as well as injectable agents.

Dr. Cohen pointed out that published studies of biosimilar-to-biosimilar switching, based on the European experience, amount to 12 trials, all of which used observational data. Two trials involved adalimumab, eight infliximab, one etanercept, and one involved rituximab. These totaled 1,223 patients. Additionally, 8 studies were reported as meeting abstracts, six of evaluated infliximab biosimilars, and one each for adalimumab and etanercept. Those trials totaled 1,295 patients. Although the studies varied in terms of their limitations and design rigor, they were consistent in finding no differences in patient clinical outcomes, immunogenicity, or pharmacokinetics and pharmacodynamics.

“From a scientific matter, we can trust biosimilar-to-biosimilar switching,” stated Dr. Cohen. “There have been no safety issues, and we’ll very likely have more (observational) data in upcoming years.” If the data continue to show no significant issues, “it would be reasonable to conclude that biosimilar to biosimilar switching does not have any clinical impact.”

Observational data will have to do here, as no biosimilar manufacturer would reasonably spend the money to conduct a randomized, controlled head-to-head trial with another biosimilar.

The Declining Value of Interchangeability Over Time

The inevitability of this discussion has a noteworthy effect: It lowers the value of an interchangeable designation over time. Consider the adalimumab situation, which is similar to one we posed a few years ago: A health plan decides to prefer biosimilar C, which is designed by FDA to be interchangeable to Humira®, around mid-2023. In doing so, the plan places an NDC block on the reference product, and moves to convert as many patients as possible to interchangeable biosimilar C. It achieves more than 80% conversion through substitution at the pharmacy or specialty pharmacy. However, the plan is offered a far better price in 2024 on biosimilar F, a noninterchangeable drug. Biosimilar C no longer has an interchangeability advantage. All of the patients who were converted from Humira were already converted. And biosimilar C is not considered interchangeable (by the FDA) with any approved biosimilar. Payers, however, will likely consider these agents freely switchable with each other, depending on how much weight the payer gives to citrate status and dose concentration characteristics of the products.

What does interchangeability mean in the realm of insulin products? We’ll delve into that rabbit hole in the next post.

Sandoz Resubmits Its Pegfilgrastim Biosimilar Application

Sandoz may be chomping at the bit to market its long-delayed pegfilgrastim biosimilar. First rejected by the Food and Drug Administration (FDA) in 2016, the manufacturer of Zarxio® (filgrastim) has completed its 351(k) biosimilar resubmission for its pegylated filgrastim agent.

The FDA’s complete response letter to Sandoz required new pharmacokinetic and pharmacodynamics data, which Sandoz has provided. According to Sandoz’s press release, “The resubmission includes new data from a pivotal pharmacokinetics (PK) and pharmacodynamics (PD) study. This was a single-dose, three-period cross-over study comparing Sandoz pegfilgrastim with US-sourced reference pegfilgrastim; Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim; and US with EU-sourced reference pegfilgrastim.” Branded Ziextenzo™, this agent was approved in Europe and launched in November 2018.

Sandoz was hoping that its pegfilgrastim biosimilar would be first to market before its 2016 set back. Several other prospective pegfilgrastim biosimilar makers also received rejections from the FDA, including Mylan/Biocon’s Fulphila® and Coherus Biosciences’ Udenyca®, both of which are now marketed. If approved, Sandoz would be (at best) third to market. However, of the competitors, Sandoz is the only manufacturer that can boast both a filgrastim and pegfilgrastim biosimilar. Of course, Amgen produces both Neupogen® and Neulasta®, the respective reference products.

A FDA decision date has not yet been announced; a decision in the late third quarter of 2019 would be a reasonable expectation.

Besides Zarxio, Sandoz already has received approval for two other biosimilars (Hyrimoz®, a biosimilar of trastuzumab, and Erelzi®, a biosimliar of etanercept, but these two have not yet been launched because of outstanding patent litigation or settlements. Despite having received approval in the EU for its biosimilar of Rituxan®, Sandoz decided not to press for US approval after receiving a complete response letter from the FDA about a year ago.

Is It About the Rebates, Net Costs, or Both?

It sounds a bit absurd, but we shouldn’t be surprised at this point: Health plans may not be satisfied if pharma companies simply dropped their drugs’ retail prices. They still want their drug rebates on top of this, says one well-known industry analyst. The pharmaceutical industry is stunned, because its members believed that the net price was the only thing that really mattered (or so they were told). It seems that payers’ addiction to rebates is even tougher to kick than originally thought.

Drug rebates
Ronny Gal

Ronny Gal, an analyst from Sanford Bernstein, told Fierce Pharma  on February 11 that UnitedHealthcare will be seeking “equivalent” rebates on medications, regardless of whether a company drops its price. According to the article, UHC executives confirmed the statement. Their logic isn’t completely crazy, but it is problematic. The rebates, plans have argued, help minimize consumer premium increases.

Let’s assume that this is the case: larger plans would lose millions of dollars in revenue if their 20% rebate, for example, were exchanged for simply a 20% decrease in wholesale acquisition cost (WAC). If the plan is truly using this revenue to subsidize higher medical costs, then members’ premiums would have to rise a commensurate amount.

Well, that just puts the pharmaceutical companies (and even biosimilar makers) in a difficult position. If drug A costs $600 per month, and to comply with the federal government’s efforts (and those of some pharmacy benefit managers [PBMs]) to lower medication prices, they drop their price to $400 per month. Don’t scoff, the makers of the PCSK9 hypercholesterolemia drugs just cut their WAC by 60%. Similarly, makers of hepatitis C virus treatments whacked their WACs by significant amounts in 2018. Assume the manufacturer of drug A was giving the PBM a 20% (or $120 per month per prescription) rebate to maintain co-preferred position, and the PBM shared half that rebate with the health plan ($60 per month per prescription). Now, let’s also assume that the pharmaceutical company refuses to add a rebate on top of this amount. Who will make up the difference, if the health plan insists upon it? The PBM? Don’t bet on it.

For biosimilar manufacturers, this lower price plus rebate scenario can be very discouraging. If you agree that a biosimilar maker can only gain access if it maintains a 25%+ discount to the reference drug manufacturer’s WAC, then the prospect of an additional rebate puts further price reduction pressure on their profitability. That could bolster the argument that pharma should steer clear of the biosimilar marketplace.

We always understood that from a payer standpoint, net cost was the primary objective. We were told many times that although it didn’t matter as much how the number was arrived at, the health plans preferred lower WAC as opposed to higher rebates. Now, we’re not so sure whether the rebate trap hasn’t ensnared those health plan executives.

Secretary Azar Announces Plan to Remove Safe Harbor Protection for Drug Rebates

One of the more challenging lines of attack on high pharmaceutical pricing has been solving the “rebate trap.” Although not a singular item in the Trump administration’s Biosimilar Action Plan, Secretary of Health and Human Services (HHS) Alex Azar had begun the process of reviewing how to begin the offensive against the current system of pharmaceutical rebating last summer. On January 31, HHS announced that they have a plan. An open question is how that plan will affect biosimilar access.  

Health and Human Services Secretary Alex Azar

“We are taking action to encourage the industry to shift away from the opaque rebate system and provide true discounts to patients at the point of sale,” Secretary Azar told the New York Times.

What Is Known to Date

In releasing its proposed rule, HHS will seek to strip pharmaceutical rebates from the existing safe harbor legislation pertaining to public plans, such as Medicaid, Medicare Advantage, and part D providers. The rule “proposes to amend the safe harbor regulation concerning discounts, which are defined as certain conduct that is protected from liability under the Federal anti-kickback statute, section 1128B(b) of the Social Security Act (the Act),” according to the announcement. “The amendment would revise the discount safe harbor to explicitly exclude from the definition of a discount eligible for safe harbor protection certain reductions in price or other remuneration from a manufacturer of prescription pharmaceutical products to plan sponsors under Medicare part D, Medicaid managed care organizations as defined under section 1903(m) of the Act (Medicaid MCOs), or pharmacy benefit managers (PBMs) under contract with them.” The expectation is that, although the rule would apply to federal health benefits, it would trickle down to private payers.

At the same time, HHS is proposing to establish two new safe harbors. To encourage the passing of rebates or other discounts directly to patients at the pharmacy counter, the first safe harbor “would protect certain point-of-sale reductions in price on prescription pharmaceutical products.” A second proposed move would protect “certain PBM service fees” under a safe harbor. This alludes to the use of contracts between a PBM and manufacturer in which the PBM receives a fixed fee in return for services that assist manufacturers (in other words, not for services provided to payers).

The pharmaceutical rebating safe harbor would be eliminated in January 2020, if the rule is enacted as written. The public comment period began immediately and will end on March 31. It will take far less time before the stakeholders publicize their views. According to the Pharmaceutical Care Management Association (a trade association representing the PBM industry), the elimination of the current safe harbor protection could create access problems. “While we are reviewing the proposed rule, we stand ready to work with the Administration to achieve our shared goal to reduce high drug costs. Pharmacy benefit managers (PBMs) are part of the solution to high cost prescription drugs. Drug makers alone set and raise prices,” stated JC Scott, President and CEO of the Association.

The trade association for pharmaceutical manufacturers stated that the proposal would benefit patient access, by lowering the cost of medications like insulin.

Leveling the Playing Field for Biosimilars

The move away from drug rebates may actually create problems for health plans, which had professed that the portion of the rebates passed through to them from PBMs had enabled plans to subsidize care costs. Therefore, the removal of the rebates may result in premium increases for Medicare beneficiaries. On the other hand, HHS believes that removal of the safe harbor could result in lower out-of-pocket costs for Medicare patients. Mr. Azar believes these lower costs could exceed 30% for not only insulin but for drugs to treat other chronic diseases.

As written on these pages many times in the past, the rebate trap significantly disadvantages biosimilar manufacturers who continually fight a battle for market access. It is at the heart of Pfizer’s lawsuit against Janssen Biotech for the infliximab business. Stripping away the safe harbor does not automatically improve access to biosimilars, as the manufacturers for reference products can simply compensate by lowering their retail prices or increasing discounts. However, it does take away the impetus for payers to favor reference manufacturers because of the rebate revenue they receive. In the long run, this would level the playing field for biosimilar manufacturers, and the effect would be amplified if these rebating practices also withered for private payers. We do know that many actions by those with the best intentions can be subverted by unintended consequences. As an expert in the pharmacy field once told me, if rebates are disallowed, “the PBMs will still find a way to make their money.” Health plan premiums may rise as PBM fees increase to compensate, and this could result in greater numbers of uninsured overall. At least in this case, it may be more difficult to see a potential downside for biosimilar makers.

United Kingdom to Save 75% on Annual Humira Spending

Since the October expiration of Abbvie’s EU patent, the potential Humira savings seem to be truly mind-blowing. After implementing its contracts for adalimumab, the UK National Health Service (NHS) should save about three quarters of the $514 million (£400 million) it spends each year on this product alone.

In a fixed-budgeted system like that in the UK, the real implications of these savings become clear. According to the NHS, this additional $385 million (£300 million) will enable it to pay for 11,700 community care nurses or 19,800 treatments in patients with breast cancer.

And to earn these Humira SavingsHumira savings, the NHS does not exclude using the originator product Humira. It has signed contracts (with large price cuts) with Abbvie, as well as with biosimilar manufacturers Amgen, Biogen, Mylan and its partner Fujifilm Kyowa Kirin, and Sandoz.

Could the US see such savings on adalimumab in 5 years? Although the competition may be fierce when the brand loses patent protection in 2023, Abbvie has created a stepped-launch scenario with its licensing agreements. Rather than a jailbreak of competition, as we are seeing in the EU with patent expiration there in October 2018, the timing of the licensing agreements may limit the drop in per-unit price, at least for the first year or so.

After that time, payers will be able to choose from all biosimilar adalimumab manufacturers, which should then drive pricing down (or rebates up) considerably, resulting in long-sought lower net costs. However, this will happen only after years of price increases by Abbvie. Abbvie has not claimed, while it is drastically slashing its price in the EU, that it will be losing money. In part, that is because its US revenues on Humira will continue to be at over $10 billion a year. Furthermore, its revenues largely reflect pure profit on the manufacturing of the product today, as its research and development costs were covered 15 years ago and ongoing marketing costs are a tiny fraction of this figure.

Despite repeated protestations in the US that healthcare resources are not unlimited, our system is not based on a fixed budget. It is not disingenuous to consider savings in the terms posed by NHS. Defining the large savings in terms of other useful expenditures give people a concrete idea of how the money can be better used. The need for savings on drug expenditures is acute in this nation, and biosimilars will eventually lead the way.

Abbvie’s Humira Price Cuts Don’t Win the Business in Denmark

Just a few short weeks ago, Abbvie announced that it intended to rely on discounts as deep as 80% in parts of the EU to retain Humira® marketshare. One bellweather EU member country has signaled that it is signing tenders with other biosimilar adalimumab manufacturers.

Abbvie Loses Danish TenderThe Center for Biosimilars reported an Email exchange with the Danish national tendering authority Amgros, which manages the country’s bidding system. Amgros confirmed that Abbvie did not provide the best bid for two tenders for adalimumab (covering January to March 2019 and covering April to December 2019). Five companies (including Abbvie) competed for the national tenders. Although Abbvie did not rank best for pricing, agreements were signed with all five companies.

According to the report, a spokesperson for Amgro said, “In both tenders for adalimumab 40 mg, we have entered into agreements with 5 companies—the agreements are ranked according to price. In both tenders, we have signed an agreement with Abbvie for Humira—but Humira does not have the lowest price (ie, is not the winner with the highest ranking).”

The importance of this action may extend beyond Denmark, as several European countries utilize others’ pricing decisions as a benchmark for their own. For example, the price for adalimumab in Bulgaria by policy cannot exceed that in 17 other EU countries.

Amgen Withdraws Membership From Biosimilars Advocacy Group

Journalist Dan Stanton reported that Amgen withdrew in September from The Biosimilars Forum, based on disagreements with the remaining eight biosimilar-manufacturing members and perhaps internal conflicts within Amgen.

Founded by 11 members (Allergan, Amgen, Boehringer Ingelheim, Coherus BioSciences, EMD Serono, Epirus Biopharmaceuticals, Merck and Co., Pfizer, Samsung Bioepis, Sandoz, and Teva), 8 now remain (B-I, Coherus, Fresenius Kabi, Merck, Pfizer, Samsung Bioepis, Sandoz, and Teva).

An Amgen spokesperson told Mr. Stanton, “As one of its founding members, Amgen supports the Forum’s mission to advance biosimilars and improve access to biological medicines. Although aligned on this mission, Amgen and the Forum disagree on how best to support the establishment and growth of a vibrant US biosimilars market.”

Areas of disagreement may have arose over the need for policies to support widespread acceptance of biosimilars and innovation in originator biologics, and the types of education and how it is disseminated to support uptake.

Amgen harbors a healthy pipeline of biosimilars as well as defending its brands against biosimilar competition. Whereas its Epogen®, Neupogen®, and Neulasta® are under active assault by biosimilars, its biosimilar versions of adalimumab (Amjevita®) and bevacizumab (Avastin®) are both approved but not marketed in the US.

As was pointed out by Mr. Stanton’s report, Amgen sponsored a YouTube video that supported use of naming conventions that differentate biosimilars from reference products (against the Biosimilar Forum’s advocacy) as well as implying that biosimilar switches can result in negative outcomes. Earlier in November, Forum-member Sandoz issued a statement in support of Pfizer’s Citizen’s Petition, complaining of inaccurate and misleading statements made by makers of reference biologics.

Amgen (as well as Pfizer and Boehringer Ingelheim) must walk a tightrope that other biosimilar-focused manufacturers do not. To be leading innovative drug makers, they systemize their efforts to research new medicines and acquire drug discovery firms, engage in lifecycle management, and aggressively protect their intellectual property. Yet both drug makers seem committed to the biosimilar side of their pipeline and growing the value of their biosimilar enterprises.

The Biosimilars Forum, formed in 2015, is an advocacy organization, competing in the policy space with the Biosimilar Council, which has members that represent a more diverse group (Apobiologix, AmerisourceBergen, Amneal Biosciences, Axinn, Biocon, Biorasi, Boehringer Ingelheim, Dr. Reddy’s Laboratories, Lupin, Momenta Pharmaceuticals, Mylan, and Sandoz). The Biosimilars Council is a division of the Association for Accessible Medicines.

Udenyca to Launch January 3, Same WAC as Mylan’s Fulphila

Coherus Biosciences surprised many on its third-quarter earnings call late yesterday. It will rely not on a lower price than its biosimilar competitor to gain marketshare after Coherus’ Udenyca launch, but on its ability to pull through on its patient and provider services and supply chain to gain significant marketshare for its biosimilar version of Neulasta®.

This is not to imply that Coherus will not offer contracts to group purchasing organizations (GPOs), hospitals, and payers.  The company intends to do so. However, the wholesale acquisition cost (WAC) for Udenyca® will match that of Mylan’s Fulphila®—$4,175 per vial, or a 33% discount from Amgen’s reference product. Denny Lanfear, CEO of Coherus added that the company’s contracting plans “will deliver additional value to payers.”

Jim Hassard, Coherus

AWAITING HCPCS CODING

Unlike other biosimilar manufacturers, this is their first product to reach the market. Not only was manufacturing and production a priority, but company infrastructure had to be ready for launch. Although Coherus pointed out that the sales force for Coherus is fully in place, they are holding back the Udenyca launch until the Center for Medicare and Medicaid Services (CMS) designates a Q code for claims and billing purposes. Therefore, the goal is a Udenyca launch date of January 3, 2019.

Jim Hassard, Vice President for Marketing and Market Access, emphasized that “Our overall launch strategy goes beyond pricing, to reliable supply and services. We’re committed to world-class execution and salesforce effectiveness.” The company’s Coherus Complete, patient and provider service site, is operational, and this will include copay support for eligible patients. Mr. Hassard stated, “This price is attractive to payers without diminishing our value proposition. We can deliver significant savings to the health system versus Neulasta.”Coherus Biosciences

CAN UDENYCA GRAB SOME ONPRO MARKETSHARE?

One interesting statement made during the call was the expectation that Coherus will go after some of Neulasta Onpro’s share of the market. Amgen’s on-body injector accounts for about 60% of all Neulasta utilization today, “but this growth has flattened out,” Chris Thompson, Vice President of Sales, emphasized. “We’re looking at the whole market, not just prefilled syringe market,” he said. “We think we’ll be able to sell through the Onpro market,” meaning that their pricing and services will attract some of this marketshare. In fact, Coherus executives believe that biosimilars may eventually garner nearly 70% of the pegfilgrastim market.

Coherus believes that there is pent-up demand for the biosimilar in the hospital segment today, which is why GPOs may represent promising contracting opportunities. They are seeking parity positioning at the payer and pharmacy benefit manager level.

This sounds fairly reasonable. Yet the vast majority of biosimilar consultants and payers with whom I had communicated had anticipated that Coherus would launch with at least a modest WAC discount relative to Mylan’s Fulphila. On the conference call, the investment banking participants wanting information on the Udenyca launch seemed caught off guard as well.

UDENYCA REVENUE TO SUPPORT COHERUS FOR NOW

Perhaps this strategy gives Coherus ample room for contracting while retaining a respectable net cost. Mr. Thompson said, “We’ll roll out a comprehensive contracting strategy for GPOs in the next week or two. It will be competitive and designed to win.”

It may need to be. Relying on better services and perhaps even a better supply chain (albeit one that is brand new) may not be sufficiently persuasive to hospital and payer P&T Committees. And Coherus needs to generate revenue from its sole product to feed its new sales team, new product development, and hungry investors.