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
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
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.
In May 2016, I interviewed Steven Avey, Vice President, Specialty Pharmacy, MedImpact, for the Center for Biosimilars. That conversation speculated on the potential for biosimilars, having only recently experienced the launch of the first biosimilar in the United States, filgrastim-sndz. At the Academy of Managed Care Pharmacy’s 2019 annual meeting last week, I sat down with Steve once again to gain his perspectives on changes in the biosimilar environment.
& Report: Congratulations on winning the Academy of Managed Care
Pharmacy Foundation’s Steven G. Avey Award! This is sort of a double honor,
first having the award initially named after you, and then many years later,
winning it yourself!
Steve, you’re considered one of the real thought leaders in
managed care pharmacy. What do you consider to be the main challenges facing your
Steven Avey, PharmD: Thank
you. There are many real challenges today. First of all, we have the potential
for drug rebates to go away. It’s clear that something is going to be done (and
we don’t know what that is), and it could apply not
only to Medicare Part D, but possibly Medicaid and commercial. We will need to
wait and see.
Another challenge relates to the Administration’s emphasis
on reducing list prices for drugs. This will not only influence the industry,
but managed care pharmacy as well.
That challenge is part of the ongoing concern about the cost
of specialty medications (and continuing price increases), and the greater call
from payers for a better understanding of the value that they’re getting from
these medications. Are the people who are taking specialty medications actually
getting real benefit?
addition to payers, employer purchasers and others have been requesting a
better understanding of the value of specialty medications. This has been
sought for 10 years or more. Are we any closer today in getting a grip on this?
Avey: I think we
are. Many PBMs are getting more involved in data management regarding these
medications. The better we get at analyzing the medical and pharmacy data
together, the closer we will get to understanding the value of these specialty
To give you an example, a PBM today is basically reviewed
and assessed on what its financial picture looks like—are you able to bend that
specialty cost trend? But if you don’t know what these specialty agents are really
doing for the patient population, how can you tell if covering them is the
right thing to do? In order for us to know that, we have to evaluate the
medical and pharmacy data together and focus on the total cost of care of that
individual member. Over time, you can say that our costs are either going down
or not. Then, we can ask the question, am I using the right agent or should we
be using those very expensive drugs for these patients?
Given the lack of the medical and pharmacy data, we just
don’t know. That’s one of my greatest frustrations.
switch to biosimilars. Do you believe that if the rebate safe harbor is removed
for Medicare, payers will also stop seeking them?
Avey: Yes. It
will definitely trickle into the commercial side. I can see a day in the not
too distant future where we don’t rely at all on rebates. It will be a new
world focused almost solely on list price reductions.
that give biosimilar manufacturers an edge?
Avey: It will be
a boon for biosimilar makers! When the rebate goes away, then all that remains
is the list price. That will be a huge advantage for biosimilars.
if I’m a reference biologic maker, whose R&D costs were paid off a decade
ago and whose profit margin is extremely high, I can still lower my WAC price
considerably to compete with the biosimilars, right?
Avey: They can,
but they will have to compete with three or even five biosimilars who do not
have to spend millions of dollars on advertising or promotions like the
innovators do to keep their brand’s exposure and visibility high. The innovator
drug maker will do everything possible to avoid losing that high market share.
Now, I haven’t seen much of this in print, but payers are
angry—they’re angry at these 10% to 20% increases in costs each year from the
innovator drug manufacturers. As a payer, if a biosimilar is available, why would
I want to support that innovator maker, who has
dramatically raised costs for the last 10 years? That gives biosimilar
manufacturers the advantage: “Hey, I’m the new guy helping you to reduce costs.
How about supporting me instead?” I think many payers will act on this message.
BR&R: In our
conversation in April 2016, that was the gist of what you said.
Avey: And I
haven’t changed my mind.
asked, how soon are you going to drop the AbbVie contracts (when there was some
expectation that biosimilars would be available before 2020), and you said, “As
soon as humanly possible.” And you weren’t the only one who said this.
And now the timeline has been extended to 2023. This just made us all the more
angry, because this is because AbbVie filed 100 patents on Humira®,
which overwhelmed what the BPCIA was intended to address. The result is that AbbVie
is going to make $16 billion a year (and more each year) for 4 more years
before we’ll be able to see some competition for their market.
Genentech (Roche) is coming out with subcutaneous forms of Herceptin®
and Avastin®. Will these introductions change the way you position the
biosimilars for these two cancer agents, when they are finally launched?
Avey: We’ve dealt
with this 15 years: It’s really no different than what we’ve seen occur with conventional
agents. Consider a sustained-release form of a brand that is approved around the
time the generic for the immediate-acting formulary is launched. You look at
the new product and ask, what does that premium in pricing buy us? Is it a
site-of-care advantage? Maybe, but does it really offset the cost of using that
more expensive agent? We generally decide to cover the lower-priced (albeit it
not as convenient) dosage form. With biologics, the cost differential between
the new agent and the biosimilar is very large, and there is very little
advantage for the new subcutaneous formulation.
BR&R: We are
seeing something similar playing out right now with pegfilgrastim. Most of the
market has moved to the use of Amgen’s on-body injector OnPro®, and
the biosimilars are being launched using prefilled syringes. To the extent that
payers are interested in eroding OnPro’s marketshare, assuming the price
difference is substantial, OnPro does represent a bit more patient convenience.
Some payers may be thinking this way. To the extent that this will happen may
predict some similar effect for the trastuzumab and bevacizumab markets.
Avey: You have to
remember that payers are receiving a lot of criticism that we’re not doing a
good job of supporting the biosimilars. Quite frankly, the biosimilar drugs
that have been approved up until now are really covered under the medical
benefit. We have a little trickle that can be covered under the pharmacy
benefit. Payers have only so much bandwidth. They know that under present
conditions, a new biosimilar has to build market share from scratch. Some have
said, “You know, it’s not worth the effort. We have other fish to fry. We’re
not going to get too excited yet about these products.”
We have an HMO client that did an amazing job moving market share
away from Neupogen® to Granix®. But they own their
prescribers and they can easily analyze the combined medical-pharmacy spend.
They saw a dramatic lowering of expenditures.
BR&R: Are you
expecting biosimilar products for trastuzumab and bevacizumab to be managed
Avey: We see
those drugs under the pharmacy benefit now. Remember that those drugs have a
greater utilization than the other biosimilars that have been launched to date.
I do think that they will attract a lot of attention. And if the rebates do go
away, that takes the market share question right off the table. The biosimilars
will do quite well.
four-letter suffixes: The FDA recently came out with an updated guidance,
saying that the agency will no longer consider adding four-letter suffixes to
previously approved reference agents. However, they will continue to add
suffixes to newly approved biosimilars and interchangeable agents.
is trying to figure out what’s next here. When we look at biosimilars’
pharmacokinetic information, one biosimilar is going to be somewhat different
than another. I don’t think it will be an insurmountable problem, but just a
headache. We’ll just have to be more in synch with our specialty pharmacies to
ensure that they stock and dispense this one biosimilar with this one
we made any progress from an educational standpoint here? Do providers and
patients still think that a product with a four-letter code is not comparable
to the originator brand? What is the level of discomfort today?
watched this carefully over the last year. I don’t think there will be huge
angst from the payer. The prescribers and to some
degree the patients that will need more educating to make them feel more
comfortable. We will need better educational materials and communications for
The situation is really no different than when we started instituting
the generic substitution laws. We heard a lot of claims that docs will never
prescribe generics, patients will never take them. We had to do a lot of
educating to alleviate their fears, and to help prescribers understand that
these drugs work like the brands work. At the end of the day, I don’t think
that this will be a long-term challenge.
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.
BR&R: Do you
think interest by manufacturers in biosimilars is gaining or waning at this
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
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.
DISTINCT MARKETS FOR
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.
DEEPER INTO THE
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%.
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.
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?
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
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.
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.
AN UNCLEAR FUTURE
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.
The assets of biosimilar drug developer Adello Biologics
were sold to Kashiv Pharma, LLC, the companies announced on January 4, 2019.
The new company will now be known as Kashiv Biosciences, with its headquarters
in Bridgewater, New Jersey.
Adello Biologics had been one of a handful of “pure-play”
biosimilar companies, in that it was not involved with any other pharmaceutical
sectors. Its two biosimilar products in most advanced development (filgrastim and
pegfilgrastim) would be subject to heavy competition if approved. The
acquisition by Kashiv now broadens the pipeline. In a press release, Kashiv cited “As a
result of the acquisition, Kashiv BioSciences’ broad business offering includes
drug delivery platforms incorporating delayed-release technology and gastric
retention systems that improve the efficacy and safety of known drugs; a
505(b)(2) pipeline of seven development products targeting unmet clinical needs.”
It does not appear that any of the 505(b)(2) agents are currently being evaluated
for approval by the FDA.
A privately held company, it had been known as Therapeutic
Proteins International since November 2016. Adello filed for Food and Drug
Administration (FDA) approval for its filgrastim biosimilar in September 2017, with
a decision expected in the third quarter of 2018. The delay in approval lends
speculation to the possibility that FDA issued a complete response letter to
the company. This filing was based on the submission
of phase 1 data only. In March 2018, Amgen filed a lawsuit against Adello
in New Jersey District Court, claiming
patent violations and that Adello failed to follow the necessary biosimilar
development protocol outlined by law.
The company’s pegfilgrastim biosimilar (TPI-120) had completed two phase 1 studies by the beginning of 2018, and it was hoped that the company would submit its FDA 351(k) application before the end of the year. Executive Vice President & Chief Business Officer Pavan Handa confirmed in an E-mail that the pegfilgrastim program “is in active development and we continue to make significant progress towards a filing. ”
Adello’s journey highlights the potential financial problems
that biosimilar-focused companies may face. As a privately owned company, its
capitalization was likely limited, and delays in reaching the market become even
more critical for companies without other revenue-generating products. The deal
with Kashiv breathes new life into the enterprise, but Kashiv, too, does not yet
have an approved biosimilar product (nor approved innovative drugs) to its
credit. Before the acquisition, Kashiv had focused on
“applying novel technologies to
improve the delivery of compounds with otherwise problematic physical and/or
chemical properties” and on abuse-deterrent technologies for opioid
It appears to us that the purchase of Adello by Kashiv, another private company, is an effort at doubling down, to attain more immediate revenue from drug sales.
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.”
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.”
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.
With the Food and Drug Administration (FDA) approval today of Coherus Bioscience’s Udenyca™ (pegfilgrastim-cbqv), the second pegfilgrastim to compete with Amgen’s Neulasta®, much attention will be now focused on the company’s November 8 earning call.
The FDA approved Udenyca on the basis of a supportive analytical similarity package, but with phase 1 data only. Over 600 healthy subjects were given the agent to test its pharmacokinetic, pharmacodynamic, and immunogenicity safety.
We should learn a great deal by the end of the week about the nature of the competition for the injectable pegfilgrastim marketplace into 2019. In the press release announcing the approval, the company said it will reveal its launch plans, including pricing, during its week’s call. On Monday, November 5, we should hear the first information about whether Mylan’s first-to-market entry, Fulphila®, has gained some traction against the injectable form of Neulasta. Mylan launched Fulphila at the end of July.
In a previous post, we discussed how Amgen’s Neulasta Onpro® patch has already captured upwards of 80% of the pegfilgrastim business. Because of the convenience of the patch formulation, it would be surprising if Onpro’s share of market eroded significantly. However, Amgen must ensure that the net cost difference between the biosimilars and Neulasta Onpro is not noteworthy. Otherwise, payers’ can be expected to try to disadvantage Onpro through step edits or greater patient cost sharing. That would take a sizable bite out of Amgen’s large slice of the $4 billion pegfilgrastim pie.
The FDA approved Udenyca for the following indication: to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. It was not approved for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. This indication language does not differ from that for Fulphila. Neulasta has the additional indication of increasing survival in patients acutely exposed to myelosuppressive doses of radiation.
Undenyca was also approved for sale in the EU, although Coherus has not launched there, awaiting a marketing partner.
A German manufacturer is considering its options after the successful completion of two clinical studies involving a pegfilgrastim biosimilar (MSB11455).
Fresenius Kabi, which completed its purchase of the biosimilar business from Merck KGaA in September 2017, announced its investigational biosimilar agent had proved sufficiently similar to the reference product Neulasta® in these phase 1 investigations (conducted in healthy participants). These may serve as pivotal investigations for the manufacturer, which said in its release, “Both studies are designed to enable the application for marketing authorization in the EU and US.” This may be the first indication that Fresenius Kabi seeks to be a player in the US.
Fresenius Kabi does not yet have an approved biosimilar on the European market. It hopes that MSB11455 may propel its fortunes on both sides of the Atlantic.
In its first study, the company reported that its biosimilar “met all primary pharmacokinetic endpoints, [maximum plasma concentration], and area under the curve, as well as the primary pharmacodynamic endpoints of absolute neutrophil count (ANC).” Fresenius Kabi added that there were no meaningful differences in the frequency of adverse events in these healthy volunteers. The second study focused on the biosimilar’s potential for immunogenicity, and this was also determined to be no different between the reference drug and the biosimilar. In addition, neutralizng antibodies were not found.
If Fresenius Kabi proceeds with an application for approval in either market, it will find a good deal of competition for pegfilgrastim biosimilars. In Europe, up to 5 biosimilars may be approved (2 already are). In the US, Mylan’s product is the only one to be approved, but another (Coherus Biosciences) is expecting a decision from the Food and Drug Administration (FDA) in early November. Two others (Sandoz and Apotex) are seeking US drug approval.
In other biosimilar news…The Food and Drug Administration’s Oncology Drug Advisory Committee voted unanimously (16-0) today to recommend Celltrion’s CT-P10 rituximab biosimilar for approval. If the biosimilar is approved by the FDA, it will be marketed by Teva….Mundipharma purchased European biosimilar maker Cinfa, which has a pegfilgrastim that has received a CHMP recommendation for approval in the EU.
The European Medicines Agency (EMA) has had an extremely busy week in the pegfilgrastim biosimilars arena. In addition to granting marketing authorization to Coherus Biosciences for its pegfilgrastim biosimilar, it has also approved the marketing of Pelgraz®, a pegfilgrastim produced by Accord Healthcare. In addition, the EMA’s Committee for Medicinal Products for Human Use has also recommended approval for three pegfilgrastim biosimilars—from Sandoz, Cinfa, and Mylan.
Mylan is the only drug maker with a marketed biosimilar version of pegfilgrastim in the United States. Its product Fulphila® hit the US market in early July. Coherus’ product, Udenyca™, is awaiting a November 2 decision from the Food and Drug Administration. Coherus is reportedly looking for a partner to market its pegfilgrastim biosimilar overseas, while it intends to market the product internally in the US. This means that Accord may have the first pegfilgrastim biosimilar to reach patients in the EU, though this advantage will be short lived should Mylan in particular gain approval.
In other biosimilar news…Boehringer Ingelheim announced positive results in its clinical study of Cylteza® versus Humira® in patients with moderate-to-severe plaque psoriasis. The study results were announced at the European Society of Dermatology and Venereology.
Samsung Bioepis Co., Ltd. announced that the FDA has accepted its 351(k) application for SB5, a biosimilar to adalimumab. Samsung is the fourth manufacturer seeking to enter the biosimilar market for Humira. Two have been approved (Amjevita® by Amgen and Cyltezo® by Boehringer Ingelheim) but are not yet marketed. A decision on Sandoz’s application is expected later this year.
In reporting lower earnings on its second-quarter revenues, Mylan may have surprised industry observers by offering the possibility of some changes in strategic direction. Although Mylan executives sounded hopeful notes on the company’s biosimilar portfolio, the hints CEO Heather Bresch provided may affect the marketing of the biosimilars as well as its other pharmaceutical business.
Chief Executive Officer Heather Bresch said that Mylan’s generic drug business was the main reason for the declines in overall revenues, with adjusted gross profit from US business down 6% from the previous quarter last year. Sales revenues from North America as a whole were down 22% compared with an increase of 10% for the rest of the world.
On a conference call to announce the earnings, she noted that “our efforts to serve patients in the U.S. have been shaped by the industry’s transformation there, and our results and guidance for 2018 are directly correlated with the ongoing rebasing of the US healthcare environment.”
According to Rajiv Malik, President of Mylan, “This past quarter, Mylan continued to execute on its commitment to expand access to medicine through the advancement of our complex product portfolio across our global diversified platform. For example, we launched Fulphila™, our pegfilgrastim biosimilar, in the US, and CHMP issued a positive opinion for our biosimilar of Humira in Europe.”
The Board of Directors released its own statement, however, indicating that it may take a number of actions that could dramatically change the picture (though not specified, these could include selling off assets, seeking a merger, or restructuring the organization). In a press release, the Board said, “we believe that the US public markets continue to underappreciate and undervalue the durability, differentiation and strengths of Mylan’s global diversified business, especially when compared to our peers around the globe. Therefore, while we will continue to execute on our best-in-class, long-term focused sustainable strategy, the Board has formed a strategic review committee and is actively evaluating a wide range of alternatives to unlock the true value of our one-of-a-kind platform. The Board has not set a timetable for its evaluation of alternatives and there can be no assurance that any alternative will be implemented.”
Observers will be greatly interested in how Fulphila performs in the third quarter and beyond, particularly around the deep discount offered by Mylan. This could be a considerable shot in the arm to Mylan’s US revenues or simply a ratification of its opinion that the US health system is incentivized by higher prices.
The first pegfilgrastim biosimilar (Fulphila™) in the US has begun marketing, and Mylan/Biocon are offering a 33% discount to the wholesale acquisition cost (WAC) of the originator product Neulasta®. The Center for Biosimilars reported a communication from Mylan confirming the action. This is a watershed moment for the pegfilgrastim category and could signal the beginning of large savings opportunities for payers and patients.
At a WAC of $4,175 per syringe, the pegfilgrastim biosimilar may be very attractive to health plans and insurers. It is also assumed that this will effectively drive down the average sales price (ASP) of the category over time. The ASP includes the WAC as well as any rebates or discounts given by the manufacturers.
The pegfilgrastim biosimilar, like the reference drug, Amgen’s Neulasta, is approved to decrease the incidence of infection as manifested by febrile neutropenia in patients receiving myelosuppressive chemotherapy.
Although patent litigation between the partners and the maker of the originator product (Amgen), Mylan/Biocon have decided to launch at risk. This means that if the District Court sides with Amgen, Mylan’s could face large financial penalties, including profits on the sales of the biosimilar.