Even Today, Patients and Payers Hold the Key to Biosimilar Uptake Success

Reading the white paper co-published March 19 by the US-based Biosimilars Forum and UK-based Medicines for Europe highlighted for me the importance of an essential roadblock to increased biosimilar uptake in the US.

The white paper outlined structural market changes needed in the US to gain comparable conversion of marketshare in the European market. Without a doubt, barrier number 1 is the patent thicket erected by biologic makers and the resulting patent litigation. This causes barrier number 2: the signing of licensing arrangements that prevent biosimilar makers from entering the market at the earliest possible date.

However, this still doesn’t address the lack of biosimilar uptake for infliximab: Inflectra® has been available for use since 2016. Whereas I placed considerable blame for this on Pfizer, which underestimated payers’ reaction to its initial discount on Inflectra. Today, I place more of the responsibility on the health plans and insurers for lacking the backbone needed to ensure a vibrant biosimilar market for infliximab. The health system can gain the greatest savings by converting to biosimilar infliximab compared with any currently launched biosimilar. With that in mind, let’s consider these agents.

According to the white paper, “Full buy-in is needed from payers to sustain a competitive market that values the most cost-effective medicines. This includes proactive incentivizing of biosimilar prescriptions, educating stakeholders on the promise of biosimilars, and requiring commercial insurers to provide access to biosimilars.”

I will take this one step further. Patients need to act on their desire for less-expensive alternatives at the physician’s office. Two things must occur to produce this result: (1) the provision of more accurate, less misleading information to patients relating the quality of biosimilars and their clinical efficacy and safety, and (2) financial incentives for patients to specifically request biosimilars.

There is no question that patients are often confused by the contradictory information they receive on biosimilars. This harkens back to generic–branded drug battles of decades ago. Without accurate education, patients will not reliably consider a biosimilar alternative to products like Remicade® . Much has been published on this issue already, and several biologic makers have been castigated about their contributions to misinformation. This must intensify if the second “pull-through” for biosimilar uptake is to be successful.

Any American patient who has faced high cost sharing or deductibles has considered ways to lower his or her costs. That includes making the decision to not refill their prescription or take their medications as directed. Infliximab is only available today as an office-based infusion, but should a subcutaneous version be approved, this, too, would be more directly in the patient’s hands.

The only way this will occur is if patients are given an appropriate choice by their health plans and insurers: lower cost sharing for biosimilars. This is accomplished easily, through the creation of a specialty biosimilar tier (or assignment of biosimilar agents on a fixed cost, tier 3–type payment). With the reference product strictly on tier 4 or 5 (co-insurance tiers with high dollar maximums), this would be the practical step to move the needle. For Medicare Part D beneficiaries, this could be as high as 33% co-insurance.

With the exception of very few payers, this has not occurred for Inflectra. It did occur for Zarxio®, as early as 2017, but it is not used for a chronic medication. When patients begin asking for lower-cost alternatives and payers provide cost-sharing structures that favor biosimilar use, Inflectra or Renflexis® uptake will begin to increase. That means payers foregoing short-term rebate revenue for longer-term cost savings. But one cannot occur without the other.

Does Mass Signing of Adalimumab Licensing Deals Add Up to Biosimilar Access Collusion?

As reported by the Center for Biosimilars, a union has filed a class-action lawsuit against AbbVie and the eight prospective biosimilar adalimumab makers who agreed to delay bringing their agents to market through a royalty arrangement.

Only Boehringer Ingelheim remains as a biosimilar maker who has an approved version of adalimumab but who has not signed on with AbbVie. United Food and Commercial Workers Local 1500 has filed the suit with the other manufacturers and AbbVie, claiming that by their actions, they are trying to “divide the market for adalimumab between Europe and the United States,” according to the Center for Biosimilars report.

This is an interesting question. The individual motivations of the first companies to come to agreement with AbbVie (Amgen, then Samsung Bioepis) included an end to interminable patent legislation in the US. They wanted the ability to immediately plan launches in Europe (starting in October 2018). The motivations of most other subsequent signees almost certainly was to not forfeit marketshare in Europe, which was needed to help sustain biosimilar development efforts for the US market. In fact, many of these prospective US manufacturers already had received approval in the EU.

AbbVie’s principal patents on Humira® expired in Europe in October 2018. The last of the principal patents are supposed to expire around 2023 in the US anyway. Was it necessary to arrange serial US launches as demonstrated in this link? Would patent litigation have continued well past the supposed patent expiration date? Knowing AbbVie, this is likely. Their several patents involving adalimumab use to treat individual diseases would provide AbbVie a basis for forging ahead with lawsuits that would have gained them additional billions of dollars in sales while the suits meandered toward conclusion.

Does this mean that access to Humira is accelerated through the signing of the royalty agreements, rather than delayed through acts of collusion? That is difficult to say. Although should the lone holdout—Boehringer Ingelheim—decide that it makes business sense to launch at risk, it could topple the carefully orchestrated structure of the agreements. Amgen believes that it will launch the first adalimumab biosimilar, and experience a few months of exclusivity in the US. At that point, Amgen (and every subsequent adalimumab biosimilar maker) would have to decide whether (1) to do the same or risk losing its advantage, (2) start working towards marketing plan B, or (3) cede the initial marketshare and its billions in revenue and wait it out. If Boehringer obtains its sought after interchangeability designation, that may well speed up the process.

Personally, I find it hard to believe that these individual acts represent premeditated collusion; although the resulting lack of access to the many biosimilar versions may look to others as an orchestrated maneuver.

Budget Proposal Floats an Idea to Discourage Pay-for-Delay Deals

The Department of Health and Human Services (HHS) had signaled in the past that it would seek to discourage the signing of “pay-for-delay” agreements. These agreements contribute to slow access to less-expensive biosimilars. The recently released budget proposal from the Trump Administration, though dead on arrival in Congress, does include a provision that could bring biosimilars to the market earlier.

Under this proposal, any reference product manufacturer involved in a pay-for-delay agreement would see drug reimbursements cut by close to 40%. Specifically, the originator drug would be paid at a new rate, ASP minus 33%, down from the standard ASP plus 4.2% (ASP + 6% not considering the financial sequester).

pay-for-delay agreements

The Trump Administration added that this new reimbursement rate would be imposed, not only for those signing other manufacturers to pay-for-delay agreements, but also if the originator manufacturer engages in “anticompetitive action” once marketing exclusivity expires. This action is likely a reaction to both the Pfizer v. Janssen Biotech lawsuit involving infliximab and the creation of patent thickets.

These provisions in the budget proposal do hold some potential. Yet the pharmaceutical industry will argue that the arrangements that are currently signed that delay launch for biosimilars of adalimumab and trastuzumab, for example, do not involve upfront payments to the prospective biosimilar manufacturers. They simply end expensive patent litigation, in exchange for royalty payments upon biosimilar sales commencing on an agreed-upon date. In contrast, pay-for-delay deals for generic drugs were just that —a large upfront payment by the brand manufacturer to persuade the generic drug maker to allow the former to rake in more profits.

Arrangements of this type do still significantly delay the launch of previously approved biosimilars. If one manufacturer decides to launch “at risk” (before patent litigation is resolved), that company could attempt to gain a large share of the market. Pfizer planned to do this with Inflectra®, but miscalculated the discounts that would be necessary to move marketshare. Janssen took action to drastically increase the rebates it offered, making it less attractive to payers to move away from Remicade®.

Perhaps the more intriguing question here, is what would be the definition of “anticompetitive action?” The administration could define this quite broadly (which no doubt will evoke actions, including lawsuits, to render the phrase harmless). If it defines the current drop-the-patent-litigation-for-royalties arrangements as anticompetitive, it could result in big savings for the government in lower payments for drugs like Humira® and Herceptin®. The definition of anticompetitive action could even be extended to exclusive positioning on formulary (in exchange for more rebate dollars). Of course, this also may depend on how the government, pharmacy benefit managers, and payers view rebates in the future.

If that should happen, don’t expect private payers to continue to reimburse for originator drugs at the higher rate. They will want similar savings (particularly if they cover both Medicare and commercial populations).

Back to reality for a moment: The budget proposal has no chance of approval in a Congress with a Democratic majority. However, this provision does signal how HHS wants to approach the pay-for-delay issue. And it may receive a warmer reception as part of other legislation.

Pfizer Receives Approval for Trazimera, the Fourth Trastuzumab Biosimilar

A fourth trastuzumab biosimilar has been approved by the US Food and Drug Administration (FDA). Pfizer’s biosimilar version of trastuzumab-qyyp (Trazimera) gained approval on March 11.

The principal phase 3 study tested Trazimera against the EU-licensed version of Herceptin®. The REFLECTIONS B327-02 study found no relevant differences in the clinical and safety outcomes for patients with HER2positive metastatic breast cancer, who also received paclitaxel. A second study tested Trazimera versus EU-licensed Herceptin in combination with docetaxel and carboplatin as neoadjuvant therapy, again demonstrating similar outcomes. The FDA’s approval covers both indications approved for Herceptin (treatment of HER2-overexpressing breast cancer and metastatic gastric/ gastroesophageal junction adenocarcinoma).

Pfizer first filed for approval of its trastuzumab biosimilar in the third quarter of 2017, and received a rejection from FDA in April 2018. Resubmission in June 2018, with additional information requested by the FDA, resulted in the current approval. The product was approved by the European Medicines Agency last year.

As with the other approved biosimilar versions of trastuzumab (Herzuma, Ogivri, and Ontruzant) in the United States, Trazimera is not yet available for prescription. Pfizer signed a licensing agreement with Herceptin’s maker Roche in December 2018, but a launch date is not yet available.

In other biosimilar news…Biocon’s biosimilar manufacturing plant has received a second citation from the FDA. The new Form 483 specified two issues, one involving sanitizing a type of barrier system and problems in tracking rejected vials.

FDA’s Gottlieb Announces Important Changes to Biosimilar and Biologic Naming

A statement by the Food and Drug Administration (FDA) departing commissioner, Scott Gottlieb, reinforced a key aspect of biosimilar naming and provided important updates to the use of four-digit suffixes for biologics and biosimilars.  

biosimilar naming

In his statement, Dr. Gottlieb said, “In January 2017, the FDA published a guidance document in which we sought to balance these concerns by using a distinguishing suffix to the proper names of biological products, including not just biosimilars, but originator products as well. By applying this policy to originator and biosimilar products alike, the FDA sought to advance the goal of patient safety—which the suffixes promote—without creating a misimpression that products with such suffixes are somehow inferior to those without. In addition, the FDA announced in that guidance that the agency was considering the process to retrospectively change the names of biological products already on the market, to begin adding distinguishable suffixes.”

In its updated draft guidance, the FDA announced that it (1) has decided not to add a 4-digit suffix to biologics that have already been approved under the Public Health Service Act, (2) transitioning products, such as growth hormone or insulins, will not be given a 4-digit suffix, (3) the FDA will continue to assign a suffix to biosimilar agents, and (4) any biosimilars that are designated interchangeable will have the usual 4-digit suffix, which will be “devoid of meaning.” In other words, the suffix will not distinguish an agent as interchangeable from one that is not.

The guidance states, “FDA has determined that the core objectives of the naming convention—pharmacovigilance and safe use—can be accomplished by applying the naming convention to biological products 170 at the time they are licensed under section 351 of the PHS Act, and without applying it to licensed biological products that do not contain a suffix in their proper names. This approach is intended to minimize the potential burden for sponsors and the healthcare systems, and to avoid potential confusion for healthcare providers and patients, given that the nonproprietary names of drugs seldom change postapproval.”

The addition of a 4-letter suffix for new biologics is problematic, as the FDA had begun assigning them for at least a couple of years. So far, FDA has given 27 new originator biologics these unique designations, and it seems that to avoid even greater confusion, new biologics will continue to receive the suffixes.

The continuing use of the 4-letter suffix is controversial not only because of the reason stated by Dr. Gottlieb, but also because these designations have not been used to any significant extent in safety reporting. As stated here and in Biosimilar Development, these suffixes have been reported in fewer than 5% of all drug safety reports filed with the FDA to date (but without causing issues as to which biosimilar was associated with an individual report). The updated guidance reaffirms the FDA’s commitment to the use of these suffixes.  

Dr. Gottlieb stated, “This framework will help secure pharmacovigilance so that the FDA can effectively monitor all biological products in the post market—originators and biosimilars—and promote patient safety. To aid in adverse event report tracking, originator, biosimilar and interchangeable products will have nonproprietary names that are distinct from each other.”

The problem with this frame of thought is that the suffixes will not achieve a greater level of security in terms of pharmacovigilance in practice. The suffixes are extremely difficult to recall: I know, I find myself today looking for references to nonproprietary names I’ve written about a hundred times. That is precisely why they will not generally be used in drug adverse event reporting.

Lilly to Launch Authorized Generic for Humalog

In reaction to the tumult over high insulin prices, the Food and Drug Administration (FDA) has been firming up its plans for a transition to biosimilar competition for insulin. Lilly, one of the dominant insulin manufacturers in the US, has decided to cut prices through the authorized generic route.

Humalog authorized generic

In this case, a manufacturer that owns a branded product with expiring patents may decide to get the upper hand on the impending competition by launching its own low-cost generic version well before other agents can be marketed. With a so-called authorized generic, the drug company may produce the new version itself or sign a royalty agreement with another manufacturer to secure a share of the profits.

The FDA wants to encourage the entry of new competitive players into the insulin arena to lower costs. However, the first entrants (for insulin glargine) were follow-on biologics, not biosimilars. Follow-on insulins are currently regulated under section 505b2 of the Food, Drug, and Cosmetics Act (which covers small molecules and early biologic compounds), not section 351 of the Public Health Service Act (which covers biologics and biosimilars). The transition to regulation under the Public Health Act is not expected to begin until March 2020.

Eli Lilly announced on March 4 that it will sell Humalog® (insulin lispro) as an authorized generic. The Humalog authorized generic will be sold at a 50% discount to the brand’s wholesale acquisition cost. It will be distributed through its ImClone Systems subsidiary. This does not mean that Humalog will no longer be sold. Instead, it will continue to offer the branded version at its same price (and rebates) to payers who prefer this arrangements. Instead, the authorized generic will be sold directly to patients or others who do not benefit from the rebate revenue.

Lilly stated that the new generic version will be available “as soon as possible.” Some believe that a 50% discount is only a half-step. At $137.35 per vial, it is difficult to believe that a patient with a drug deductible or who is uninsured can easily pay the monthly cost of insulin treatment. Brand manufacturers can partly deflect scrutiny through such actions. However, with the prices of several older and brand new categories of drugs considered too high, pressure will remain on drug makers, law makers, and regulators to further lower costs.

In related biosimilar news…Four US Senators have sent a letter to the FDA to ensure that the transition period does not slow competition for insulin products. One aspect of this was the potential need for prospective makers of 505b2 insulins to have to resubmit their drug applications under the 351(k) biosimilar provisions. This could significantly delay entry into the market.

Comparing Biosimilar Approval Progress by the FDA and EMA

It is widely reported that European biosimilar development is way ahead of that in the US. In a number of ways, this is true. However, when talking about biosimilar development in the EU compared with the US, we really should take a look at the bigger picture.

First of all, let me specify that I’m talking about biosimilar approvals, not launches. In the latter case, the US is way behind, not even viewable in the distance.

Obviously, the US lags because it got a later start, first in promulgating the BPCIA in 2010, and then in developing the biosimilar regulatory pathway. The US system then tried to shoot itself in the foot with the “patent dance,” which also does not exist in the EU. Even America’s inability to master the steps of the patent dance did not deter initial interest in biosimilars, from inside and outside the nation. Overall, the US failed to take great advantage of the pioneering work of European policy makers in divining a regulatory pathway for biosimilars, and has been playing catch up ever since. In a sense, however, the US’s regulatory machinery has caught up, and perhaps exceeded the pace of the European Medicines Agency (EMA) in approving biosimilars.

Biosimilar approvals

This is a complicated comparison, outside of numbers alone. The chart below offers a view to the Food and Drug Administration’s (FDA’s) 17 current approvals, all accomplished within seven years of the pathway being available (and the seventh year, 2019, is still young). An analysis of information from the Generics and Biosimilars Initiative demonstrates that only 13 biosimilars were approved in the EU seven years after the pathway was implemented.

A closer look reveals a couple of important points: (1) The EU’s first biosimilar approvals were for growth hormone drugs, which were not considered biosimilar products in the US (until 2020); (2) epoetin biosimilars dominated 2007 approvals with five; and (3) filgrastim biosimilars comprised the main approvals for 2008–2010 in the EU. Between 2009 and 2012, the EMA approved only three biosimilars, two of which were filgrastim molecules. In 2013, an impressive array of biosimilars were approved in the EU, including yet another filgrastim and growth hormone, two infliximabs, and follitropin. The EU has made tremendous progress with new molecules over the past couple of years, including the rush of rituximabs in 2017, and pegfilgrastims and adalimumabs in 2018, all corresponding closely with patent expirations. In fact, of the 54 biosimilars approved in the EU (as of December 2018) in its 13 years of experience with biosimilars, 30 (55%) were approved in 2017 or 2018.

That doesn’t mean the FDA hasn’t made missteps—there have been plenty. Remember, the patent dance was not FDA’s doing, that was statutory not regulatory. They do need to admit their responsibility on the four-digit suffixes and the long delay in finalizing guidances, especially on interchangeability. And there are certainly biosimilar drugs that were approved by the EMA but rejected by the FDA.

Overall though, the FDA has not been the reason only seven biosimilars in four drug classes are now available for prescription. Those are uniquely American problems.

Payers Focus More on a Biosimilar’s Price Than on Clinical Data: A Retrospective

It can be fun to go back in time! That’s the case with an old column I wrote for the Center for Biosimilars, just after Zarxio was approved. Here, I reprint a portion of the column, with some additional commentary.

A RAND study from 2014 boldly predicted $44.2 billion in savings from biologic drugs over the 10-year period ending in 2024. The study’s authors believed that upwards of 20% of the savings would come from the anti-TNF inhibitors alone.

These savings would salve the wounds of payers and purchasers suffering annual double-digit increases in specialty pharmaceutical costs. It has kept them up at night. Worries about the affordability of medicines have kept patients and their families on edge. All of this light focused through the magnifying glass, refracting to a point, has heated up attention on the first biosimilars in the 351(k) approval process. US health plans, pharmacy benefit managers, and insurer executives have been anticipating the push to biosimilars and their possible savings since the implementation of the Biologic Price Competition and Innovation Act in May 2010.

Expectations have pent up that biosimilars will begin to relieve the pressure building from the annual double-digit specialty drug trend. If payers are given 20% and 25% lower net prices, they will likely jump at the opportunity to save millions of dollars, if they can. That means putting net pricing ahead of clinical data when making coverage decisions (assuming no significant immunogenicity differences, as payers and providers would consider this a powerful disincentive).

Payers may presuppose that the Food and Drug Administration (FDA) will do its utmost to evaluate the equivalence in outcomes and pharmacokinetic/ pharmacodynamic characteristics of the agent. The real question is whether payers care enough about the clinical data to make extrapolation a potential issue if the FDA does not. They may well leave that decision to the prescribers, taking a more laisse faire approach, as they did in the very early days of generic drug introductions (before the days of automatic generic substitution).

Today’s Commentary:

Well, the verdict seems to be in, both from payers’ and providers’ perspectives. Payers are leaving it up to the FDA, and in some cases, without any clinical data in patients (just phase 1 trials in healthy volunteers), to determine the appropriateness of biosimilars in several disease states.

Proprietary market research, as well as individual conversations with payers, support that they have crossed a critical point of confidence—the safety and effectiveness of using a biosimilar instead of a reference product is no longer much of an issue. Any question about extrapolation, similarly, is no longer deemed clinically relevant in approved biosimilars. This may not be the case with a future product. We must also await experience involving FDA approvals of products with “skinny labels” or limited indications. In these cases, we don’t know yet whether plans and insurers will discourage use of a biosimilar for the reference product’s full slate of applications (privately, they have told me they wouldn’t discourage this use, assuming similar dosage forms).

However, payers hunger for biosimilar choices. Not necessarily to add to their formularies, but to force originator manufacturers to halt further price increases. They want the opportunity to worry less about one biologic agent for which next year’s expenditures will jump—and by how much exactly? The few biosimilars approved in the US have forced WAC pricing (and ASP pricing) down. We are expecting the same for the latest market entrants, like pegfilgrastim.

As for RAND’s predictions? Not enough has happened from 2014 until now to make one think that cumulative savings of $44 billion is realistic. It is possible, however, if one considers the near-term launches of trastuzumab and bevacizumab biosimilars. The one-year savings from adalimumab biosimilars may top $8 billion by itself (out of total revenues exceeding $20 billion prior to the introduction of these biosimilars).

It should not have even been this close.

A Conversation With Doug Long, IQVIA

Doug Long, Vice President of Industry Relations at IQVIA (formerly QuintilesIMS), spoke with us about some of the intracacies of the filgrastim and pegfilgrastim marketplace, and regarding improving access to biosimilars in general. 

Doug Long
Doug Long, IQVIA

BR&R: Do you think interest by manufacturers in biosimilars is gaining or waning at this time?

Doug Long: It’s somewhere in between those two. A lot of people are staying in the game to see how it plays out. Maybe discouraged most accurately describes their feelings at this time. They are discouraged, because there are 17 approved products but only 5 are available. And the uptake of those on the market is not that great, particularly compared with the uptake in Europe.

BR&R: I can see how manufacturers and payers would be discouraged right now. You’re right, in the European market, we’ve seen a great deal of uptake and significant discounting as well. So many factors affect biosimilar coverage and uptake. It may also relate to the individual biosimilar’s disparate marketplace situations.


In the US, based on the utilization numbers seen today, do you believe the infliximab, filgrastim, or pegfilgrastim markets will best characterize how other biosimilars (e.g., Avastin® or Herceptin) will perform when available?

Long: Well, with the filgrastim molecule, you need to look at both filgrastim and pegfilgrastim, and their routes of administration (prefilled syringes and on-body injectors). Granix® and Zarxio® have the majority of the dollar share on the filgrastim side. It’s too early to tell on the pegfilgrastim side, though Amgen has a 61% share of that Neulasta® molecule with its Onpro® formulation. The addressable market for the molecule is really only the remaining 39%.

You also have to make a distinction between how much of the market is controlled by the pharmacy benefit managers compared with the hospital group purchasing organizations (GPOs) or buying groups. Most of the filgrastim and pegfilgrastim is controlled by the hospital buying groups, and that’s also going to be the case for the cancer-treating biosimilars. There’s no doubt in my mind that when Humira® or Enbrel® are available, the PBMs will embrace the biosimilars. There are just so more complexities on the hospital side of the market that it makes it more difficult for them to move towards the biosimilars.


BR&R: There’s an interesting situation brewing in the filgrastim market. The success of Granix and really Sandoz’s Zarxio penetrating the market has contributed significantly to the drop in total sales revenues for filgrastim sales combined. However, how much of this decrease is attributable to migration to pegfilgrastim, and Neulasta Onpro in particular?

Long: Sure, look at their revenues today. Filgrastim is at $611 million in annual sales and pegfilgrastim is at $4.3 billion. Of that $4.3 billion, Onpro accounts for 61%.

BR&R: At Coherus’ fourth-quarter earnings conference call, their CEO indicated that he thought the Onpro marketshare might be vulnerable to the pegfilgrastim biosimilar, which is available today in prefilled syringes. Obviously, that would mean selling Undenyca® at a more enticing price, below the 33% discount currently offered. Do you think that Onpro sales erosion is likely or does the formulation offer real value?

Long: That could work, but the thing about Onpro is that when you finish your chemotherapy for the week, they put the injector on you and you don’t have to go back to the doctor’s office for a pegfilgrastim injection the next day. That’s one of the reasons it is as popular as it is—it reduces hospital and doctor expenses at the end of the day, and is more convenient for the patient.

BR&R: Biosimilar manufacturers like Coherus have expressed interest in developing its own on-body injector for its biosimilar. It seems to present distinct advantages. Does that mean that the biosimilars will be relegated to fighting only for that prefilled syringe market, the remaining 39% of utilization?

Long: It’s probably too early to say. Fulphilia® has only been marketed since July, and the other one [Udenyca] was launched only recently. We’ll have to see what kind of uptake it gets. Also, we’ll have to see what happens when other players come to the market. The more drugs you have available, the more share erosion from the originator you’ll likely see. Yet that did not happen with Remicade…

BR&R: That may be more of a special situation, considering the actions taken by Janssen Biotech to prevent coverage of both Pfizer and Merck’s products.

The filgrastim/pegfilgrastim markets are also different for that reason: Amgen did not aggressively defend their market share on the prefilled syringe originator products (i.e., Neupogen® and Neulasta). Rather, they focused on getting conversions to Onpro. So the biosimilar manufacturers were not facing aggressive defensive tactics, like those employed by Janssen. 

Long: Yes, but they will defend Onpro as much as they can.

BR&R: And Amgen established Neulasta and the Onpro formulation at the same price point.

Long: It made sense. It was a good defense mechanism.

BR&R: It does force the biosimilar manufacturers to work harder to gain business.


BR&R: The Administration has several initiatives that may directly or tangentially affect the biosimilar market. These include the Medicare International Pricing Index, the move to place Part B drugs into Part D (and allow step therapy and other UM tools), the reevaluation of drug rebate safe harbors, and of course, the individual components of the Biosimilar Action Plan. Do you think this will ultimately result in artificial price deflation? Would that be helpful or harmful to biosimilar makers?

Long: That’s a question that I really don’t have an answer for. Who knows what’s going to happen? People have started to make moves to reduce WAC prices, like Amgen on their PCSK9 inhibitor and Gilead on their hepatitis C treatment. Gilead created an “authorized generic” to reduce its price dramatically.

People are starting to play around with it. Maybe to get adopted, a biosimilar maker may actually have to raise their drug’s WAC price higher than the originator, and then give a larger rebate.

Biosimilar Bytes

In the absence of really big biosimilar stories with far-reaching implications, let’s start with some interesting bits on biosimilars to begin this week.

First, insulin maker Eli Lilly asked the Food and Drug Administration a very interesting question, in comments on the agency’s guidelines on transitional drugs. Lilly requested clarification of the rules under which it might introduce an authorized brand of insulin (that is, a lower-priced version of an existing insulin brand). The insulins are one group of medicines that is scheduled to transition to regulation under the Public Health Services Act in 2020, and thus be subject to formal biosimilar competition.

Second, Boehringer Ingelheim, which received FDA approval to market its adalimumab biosimilar Cyltezo® in August 2017, received a positive ruling in its patent litigation case with AbbVie. A federal court judge ruled that AbbVie, which makes the originator product Humira® must turn over all papers related to the Humira patents. This may actually move the court case out of the discovery phase, according to Fierce Healthcare, and potentially closer to an actual, early biosimilar launch.   Third, Health Canada has decided not to add a four-character suffix onto the names of its biosimilars and biologics. Instead, it will rely on its specific drug identification number as well as the nonproprietary names to identify medications being taken. This of course, contrasts with the FDA’s practice. The FDA is the only major advanced regulatory system that requires the use of a suffix to distinguish biosimilars and their reference products. And it is not used by providers.