[Ip-health] FT: Rivals line up to take on world’s best-selling drug

Thiru Balasubramaniam thiru at keionline.org
Wed Oct 17 07:56:18 PDT 2018


AbbVie Inc
Rivals line up to take on world’s best-selling drug
As the European patent on AbbVie’s Humira expires, biosimilars are ready to
target $20bn market

Sarah Neville, Global Pharmaceuticals Editor OCTOBER 14, 2018

In the world of biologic drugs, there is no bigger opportunity.

On Tuesday, the patent that for 15 years has protected Humira, the world’s
best-selling prescription drug, from generic competition expires in Europe
— triggering a tussle among a string of the most prominent names in the
pharmaceuticals industry to secure a slice of a near $20bn global market.

The development will turn a spotlight on the developing threat posed by the
rise of biosimilars — and open up a new frontier in the industry’s attempt
to secure an adequate return on its investment, as cash-strapped payers
seize on this new wave of copycat drugs as a way to cut costs.

The numbers tell the story. Worldwide sales of Humira, developed by US
group AbbVie, last year stood at $18.43bn, according to data provider
EvaluatePharma. In 2024, this will have fallen to $14.19bn it forecasts.

Among big name companies poised to enter the market with their versions of
the drug are Japan’s Fujifilm Kyowa Kirin Biologics, which has granted
Mylan an exclusive licence to commercialise Hulio in Europe; Amgen; Sandoz;
Biogen; and Samsung Bioepis. All have won European regulatory approval for
their Humira substitutes.

Another company, Boehringer Ingelheim of Germany, remains in patent
litigation with AbbVie and has no plans for a European launch, despite its
medicine being approved for sale in the EU.

Tony Mauro, chief commercial officer of Mylan, pointed out that Europe,
where the company is already firming up its launch plans, is “a $4bn
marketplace”, with the UK alone spending $635m a year on Humira, which
treats a range of conditions including rheumatoid arthritis, psoriasis and
Crohn’s disease.

“There’s certainly a mutual excitement from the market because usually this
product is one of the top spends, if not the number one spend” by many
governments and health systems, he added.

For AbbVie, however, the looming patent expiry is a significant threat.
Humira accounted for 66.4 per cent of its sales in 2017, a figure that is
expected to dwindle to 39.2 per cent in six years, according to Evaluate.
The company has fought to protect its patent through the US courts, aiming
to delay the launch of the medicine in its biggest market until 2023.

In a statement the company, which declined a request for interview, said it
“welcomes the introduction of biosimilars that have demonstrated they are
as safe and efficacious as their reference products.”

However, it argued that “patients who are stable on their existing biologic
therapy should not be switched to another product for non-medical reasons”.

AbbVie was building on the foundation of Humira, to develop “an extensive
immunology portfolio” that would “help us maintain our therapeutic
leadership, drive continued growth and make an ongoing impact on patients’
lives”, it said.

But, as credit rating agency Moody’s pointed out this month in a report on
the biosimilars market, competition from biosimilar drugs, or follow-on
versions of complex biotech drugs, represented “a rising threat for branded
pharmaceutical companies”.

Driving the shift is the imperative, shared by health systems around the
globe, to cut the cost of caring for a growing and ageing population.

Europe is ahead of the rest of the world in adoption of biosimilars, and
the UK’s taxpayer-funded National Health Service is in the vanguard,having
already shifted 80 per cent of eligible patients on to a biosimilar version
of Rituximab, a blood cancer drug made by Roche.

An NHS commissioning document giving guidance on the market for Humira
biosimilars, seen by the Financial Times, stated: “Our aim is that at least
90 per cent of new patients will be prescribed the best value biological
medicine within three months of launch of a biosimilar medicine, and at
least 80 per cent of existing patients within 12 months, or sooner if

To achieve this, the NHS has hit on a novel approach: while the most
“competitively priced suppliers” will win a bigger share of the market “all
suppliers will get access to at least some of the market upon receipt of a
compliant bid to avoid dominance”, according to a second document issued
last week.

Warwick Smith, director of the British Generic Manufacturers Association,
said: “It is all about making sure there are multiple suppliers in the
market . . . it won’t be ‘lowest price company gets all’.”

Sandoz, the generics arm of Swiss drugmaker Novartis, announced “a global
resolution of all intellectual property-related litigation with AbbVie”
over its biosimilar, Hyrimoz, just last week. Its biosimilar is now ready
for launch on Tuesday.

Tim de Gavre, UK head of Sandoz, said: “Rituximab has just gone like a
train . . . the NHS has Humira in focus and I’m thinking this could be one
of the most successful biosimilars for the NHS in terms of driving uptake
and savings.”

A perennial worry for biosimilar manufacturers, however, is that they will
be pressed into steeper discounts than they can sustain. Biosimilars can
take up to nine years to bring to market and consume up to $200m of
investment; in contrast a “small molecule” generic drug generally takes a
maximum of three years and costs only a few million to develop.


Analysis Drugs research
Drugmakers’ unorthodox route to boosting biosimilars
Rajiv Malik, president of Mylan, suggested that quality and continuity of
supply, not simply price, must be a factor in payers’ commissioning
decisions. “You cannot just drive the cost down to a point that business
doesn’t make sense just from the cost point of view,” he said.

Chad Pettit, executive director for global value access and policy for
Amgen’s biosimilars business unit, said its Humira biosimilar, Amjevita,
would be launched in all 28 EU member states as well as Norway, Iceland and

While emphasising he could not comment on Amjen’s own pricing strategy, he
said that “the savings for biosimilars will be less than the savings
achieved from traditional generics since biosimilars are more challenging
and expensive to develop”. “If you look at pricing, it’s really going to
depend on the market dynamics and vary by region and country,” he added.

Nonetheless, Mr Pettit concluded, “high-quality, reliably supplied
biosimilars” will offer “the potential for increased access, cost savings
for patients, to payers, to hospitals, health systems. They’re going to
have an impact.

Agreements hold up US launch
While excitement about the advent of biosimilar versions of Humira is
building in Europe, it will be some time before US patients are prescribed
these medicines.

Part of the reason is specific to the drug. Amgen led the way in reaching
an agreement with AbbVie that it would not launch its Humira substitute in
the US until 2023, and Mylan, Samsung Bioepis and Sandoz have followed suit.

Boehringer Ingelheim is the only company with an FDA-approved biosimilar
that has not settled with AbbVie in the US and aims to launch its Humira
substitute there “as early as legally possible . . . and certainly before
2023”, it said.

While it had planned to bring its biosimilar, Cyltezo, to European
patients, “due to the patent litigation with AbbVie in the US, we will not
commercialise our biosimilar in the EU”, it added.

But the broader climate is also far less hospitable to biosimilars across
the Atlantic.

In a report this month, credit rating agency Moody’s said that in the US
“adoption of biosimilar drugs has so far been slow due mainly to patent
protections on many large biotech drugs and also reimbursement challenges”.

Pfizer is taking legal action against Johnson & Johnson, alleging it has
violated US antitrust laws by hampering uptake of its biosimilar version of
Remicade, a J&J drug.

The outcome may help to determine the speed and extent of biosimilar
penetration in the US, experts say.

Pfizer, Biogen, Novartis, Amgen and Mylan have already launched other
biosimilar drugs and are expected to bring additional products to market in
the next two years, Moody’s noted.

“Both branded and generic drug manufacturers are targeting biosimilars as a
source of future revenue growth, while more companies are seeking to enter
the market driven by a second wave of biologic drugs losing patent
protection and expected lower development cost.”

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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