In reporting its second quarter earnings, Momenta Pharmaceuticals stated on August 2 that it no longer plans to market M923, its biosimilar version of Humira®.
Momenta announced the Company will cease active development of M923 at this
time, due to changes in the market opportunity associated with Humira patent
litigation settlements,” according to a company press release.
In 2018, Momenta decided to drastically scale back its biosimilar development as part of a strategic review. However, it continues to partner with Mylan on one remaining biosimilar candidate, M710. This is a biosimilar version of aflibercept (Eyela®).
Momenta’s troubles were first apparent after it completed its phase 3 trial of M923 in psoriasis. The clinical study pitted the biosimilar versus the EU-licensed version of adalimumab, and was successfully completed in 2017; however, no FDA filing ensued, despite a company announcement that it would occur in 2018. Later that year, the company stated that it delayed filing for financial reasons, but it would continue to seek a partner to commercialize the product.
In 2018, it signed a licensing agreement with AbbVie, which would have allowed it to launch in December 2023—in the back of the pack of licensed biosimilars in terms of timing (which could not have helped its efforts to seek a partner). In view of its refocusing its strategic outlook, the delay in filing a 351(k) biologic licensing application (BLA) application with the FDA may have made some sense from a couple of perspectives
First, the company may have thought twice about continuing expenditures if it was undecided as to whether it would remain committed to the biosimilar development. These expenditures could be quite significant (beyond payment of user fees) if the FDA requested additional data in an initial review of the BLA.
Second, with a potential launch date of December 2023, Momenta certainly had time to get its ducks in a row. If a commercialization partner could be lined up before the BLA filing, that company could help shoulder additional associated costs.
In any case, Momenta’s pull back is not entirely unexpected. Though it intended to file an application with the European Medicines Agency early this year (which would not have required a further delay in launch), this also did not occur (probably because of existing biosimilar adalimumab competition in Europe).
Momenta’s pipeline, beyond aflibercept, consists of other biologics for rare diseases. Its marketed products are for generics of Copaxone® and Lovenox®.
According to a study published in the Journal of
Managed Care and Specialty Pharmacy, managed care pharmacy executives are
fully onboard with encouraging the use of biosimilars: Eighty-four percent
agree that these FDA-approved agents are safe and effective for use in patients
who are taking a reference product.
The researchers sent survey invitations to more than 10,000
members and contacts of the Academy of Managed Care Pharmacy. The survey,
conducted in October 2018 was limited to the first 300 respondents. All potential
pharmaceutical industry participants were excluded through the use of screening
questions. Roughly two-thirds of those participating were pharmacy directors or
The survey asked whether they believed certain policies
would improve biosimilar uptake. The results indicated respondents’ belief that
prescriber education was still a principal problem (Table). However, they also
looked inward, as formulary policies and reduced patient cost sharing may also be
key opportunities for improving uptake. Indeed, only 20% of those surveyed were
working in health plans or insurers that have established preferences and
policies to promote biosimilars over reference products. Eleven percent (at the
time of the study) preferred biologics to biosimilars. This may have changed significantly,
based on UnitedHealthcare’s recent moves to favor reference agents.
TABLE: LIKELIHOOD THAT SPECIFIC
STRATEGIES CAN OVERCOME BARRIERS TO BIOSIMILAR UPTAKE
Extremely or Likely to Be Successful
Prescriber education on switching studies
Clear FDA guidance on substitution
Formulary policy for treatment-naïve patients
Prescriber education on real-world studies
Expanded Medicare/Medicaid policies
Reduced patient cost sharing for biosimilars
Formulary policies for switching
Government-funded interchangeability studies
When asked about how formidable these challenge were to overcome, 61% said that provider education was “extremely difficult” or “difficult” to overcome. The inevitable pricing and contracting issues were a close second, at 57%. Respondents offered that this was a competitive hurdle that biosimilar manufacturers must tackle—they need to be more aggressive at launch in terms of discounts off of retail prices and contracting. Concerns about biosimilar safety and efficacy among payers were the least worrisome, with only 23% rating this challenge difficult or extremely difficult.
Only 9 months ago, when the survey was conducted, the US biosimilar
arena was far different. It took place after approval and launch of the first
pegfilgrastim biosimilar but before the launch of the cancer-treating
biosimilars. The discussion of rebate safe harbors was in full swing, the
federal government was thinking through its approach to peeling back the patent
thicket, and a war on drug pricing was being waged. Today, only the drug
pricing efforts are still ongoing. Any hopes for an adalimumab biosimilar
launch before 2023 have disappeared. However, a handful of critical launches (e.g.,
Udenyca®, Kanjinti®, Mvasi®) have pressed more
immediate discussion of biosimilar uptake.
The results of this survey demonstrate once again that
pharmacists working in managed care organizations are very open to helping spur
biosimilar access. Both the manufacturers and payers need to take advantage of
this opportunity today.
Imagine this interesting and perhaps very real-life scenario.
It could have several implications for the present biosimilar marketing
A reference manufacturer, we’ll call them Arby, signs
multiple licensing deals with biosimilar manufacturers, to launch their
products sequentially in 2025. The licensing deals all conclude outstanding
patent litigation between the parties. But one biosimilar manufacturer doesn’t
sign. We’ll call them Brooklyn Industries (BI for short).
Despite Arby’s contention that its patents on the reference
product Yultira are valid until the year 2045, BI decides to launch at risk in July
2020. According to the phased launch schedule, another manufacturer, Thousand
Oaks, was supposed to have the first biosimilar available on the market, with a
three-month jump on the other seven competitors. Does that really give BI a
five-year start over all of its competitors? And what if BI had an
interchangeable biosimilar designation? Would that enable them to lock up the
Deals: The Acceleration Effect
This scenario is actually playing out today with Amgen’s
launch announcement of its trastuzumab and bevacizumab biosimilars (Kanjinti®
and Mvasi®, respectively). Other manufacturers, including Pfizer,
Samsung Bioepis, Mylan/Biocon, Teva/Celltrion have licensing agreements in
place with Genentech (a subsidiary of Roche) for launch of their Herceptin®
biosimilars. Only Amgen’s Mvasi and Pfizer’s Zirabev® are approved (so
far) to compete for the bevacizumab business. The details of the licensing
deals signed by Roche have not been released publicly, so we do not know when
the first “authorized” biosimilars were supposed to launch. Conjecture abounded
that it would be in 2019, nevertheless.
How does Amgen’s Kanjinti launch affect the licensing agreements
that were signed with Roche? Does it mean that Amgen gets a substantial head start
on the competition? Do the licensing contracts consider this possibility?
According to Kevin M. Nelson, JD, at the Chicago-based law firm Schiff Hardin, this scenario is considered in a typical pharmaceutical licensing arrangement. “Typically, settlement agreements in the pharma space include what are called acceleration clauses. Such clauses will allow an agreed-upon launch date to be accelerated to an earlier date in the event the patent or patents are invalidated or found not infringed in another litigation, or if a competing product or authorized competing product comes on the market before that agreed-upon date.”
He added that these acceleration provisions “can come in a variety of flavors from a change in royalty rate or structure, a requirement to leave the market if the ‘unauthorized entrant’ leaves the market, or perhaps agreed damages.”
Accelerating Clauses Are One Thing. Accelerating Launch Is Another Matter
fact that Amgen has announced its immediate launch may present more pragmatic
problems for the other manufacturers, Mr. Nelson pointed out. Let’s say that
you were a member of the Mylan/Biocon team. Your product was approved more than
18 months ago (the first one approved). Let’s also say that your licensing
agreement with Genentech allowed you to launch after November 1 (a purely
speculative, arbitrary date). Finally, assume that your licensing agreement was
generous: it allowed you to launch as soon as possible after another competitor
jumped the starter’s gun. Is it feasible to launch immediately, perhaps four months
“The biosimilar companies cannot just fire up the machines and have product ready tomorrow,” stated Mr. Nelson. There are all of the logistical issues surrounding a launch that must be considered: “Manufacturing, packaging, sales, and distribution all take time,” he said. “And you don’t want inventory to go bad—especially not this type as it is expensive. They may have some reserve lots or made small batches just in case, so we could see a trickle into the market.”
also, that payer and health system contracts are not arrived at overnight. Even
if the Mylan/Biocon team did have lots available for shipment, they might not
have places in the US to ship, other than to a group purchasing organization or
payers will not cover pharmaceutical agents outside of medical exceptions
before the Pharmacy & Therapeutics Committee review, and this can happen anytime
between 60 days and 9 months of the launch. And this is not a product that will
revolutionize therapy or immediately fill an unmet clinical need. Only large
discounts can move the needle here, and establish a contract quickly. Therefore,
the anticipated short window of opportunity that Amgen may have in launching
Kanjinti may get a little shorter but perhaps by not much.
When I mentioned the Arby, er Abbvie, scenario, Mr. Nelson agreed that it would be an entirely different ballgame. Had Boehringer Ingelheim decided to enter the market (as an interchangeable or not), their launch “would have caused absolute chaos.” Imagine trying to pull forward launch date plans of seven manufacturers by three years!
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.
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.
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
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.