[Ip-health] FT: Drugmakers take unorthodox route to boosting biosimilars

Thiru Balasubramaniam thiru at keionline.org
Sun May 6 15:00:40 PDT 2018


https://www.ft.com/content/170e9950-3806-11e8-8b98-2f31af407cc8

Sarah Neville, Global Pharmaceuticals Editor

 APRIL 18, 2018

Jatinder Harchowal, chief pharmacist at London’s Royal Marsden Hospital,
the specialist UK cancer centre, does not look like a revolutionary.

But the measured 48-year-old is leading a transformation in the shape and
cost of cancer treatment — with large implications for the global pharma
industry.

Working with Sandoz, the generics arm of Swiss drugmaker Novartis, he and
his colleagues have, in just six months, helped to shift roughly 80 per
cent of eligible patients in England to a “biosimilar” version of Roche’s
blood cancer medicine Rituximab, achieving an estimated £80m in savings for
the UK’s taxpayer-funded health system.

Yet rather than continuing to use Sandoz’s biosimilar, the Marsden has now
chosen one manufactured by privately owned Napp Pharmaceuticals, which
brought the first Rituximab copycat to market last year.

Sandoz’s decision to invest in a project to educate physicians and patients
about copycat versions of biologic drugs — medicines made from living cells
— with no guarantee of an immediate commercial return, underlines the
potential it sees in a market which it says will be worth $14bn by 2020.

Building confidence among doctors and patients through such initiatives is
seen as crucial to the take-up of biosimilars, especially in oncology.
Sensitivities often stem from the fact that very minor differences in
components from the originator drug are permitted.

Emphasising that the work would not have happened without the resources
Sandoz was able to commit, Mr Harchowal said: “We felt that to engage the
clinical mind and heart, you had to really, really make sure people
understood how biosimilars . . . were offering the exact same clinical
effective outcomes, with the same safety profile but at a potentially much
cheaper cost.”

The European Medicines Agency sanctioned its first biosimilar more than a
decade ago and has a highly developed regulatory framework, in contrast to
the US where far fewer products have so far been approved.

Keen to control costs, health systems across Europe are embracing
biosimilars but Mr Harchowal said the UK was far ahead of most of the rest
of the continent in the scale of its biosimilar switch.

Some of the best-selling biologics are set to lose exclusivity in the
coming year, including Humira, AbbVie’s rheumatoid arthritis drug, which
had sales of $4bn in Europe in 2017. The first biosimilar version is likely
to be available by the end of this year.

But as the work at the Marsden — in partnership with University College
London Hospitals and the Christie in Manchester — demonstrates, the big
opportunity is in biosimilars used to treat cancer.

The three biggest selling cancer drugs in Europe have had biosimilar
versions approved in the past few months: Rituximab; another Roche drug,
Trastuzumab, marketed as Herceptin and used to treat breast cancer; and
Bevacizumab, marketed as Avastin, which is used to treat a number of
cancers and is made by Genentech, a division of Roche.

The Swiss drugmaker’s exposure was reflected in a 2 per cent fall in
European pharma sales last year.

Explaining Sandoz’s participation in the cancer project — with no certainty
its own biosimilar would be selected — Tim de Gavre, the company’s UK head,
said: “We have a vested interest in creating a sustainable environment
around biosimilars where we see them being implemented in the right way.”

The shift in the NHS’s stance is already evident. In the last financial
year, it has saved £170m through the use of three biosimilars — well on the
way to a goal set by Simon Stevens, head of the health service in England,
to save £300m from this approach by 2021.

However, the concern for companies that invest in biosimilars is that
health systems will drive so hard a bargain the venture becomes uneconomic,
reducing the very competition that can help to curb spiralling costs.

The NHS succeeded in negotiating discounts of up to 60 per cent for
Retuximab biosimilars, according to Mr Harchowal.

Chrys Kokino, global biologics head for US drugmaker Mylan, which has seen
prices for its generic drugs squeezed in recent years, said his own company
was “very heavily invested [in] and committed to the space in biosimilars”.

However, he added: “If we go down this [route] of triggering price wars
between manufacturers, ultimately . . . some manufacturers may believe that
the price has become so low that they will either exit the market or they
will selectively only enter certain markets, diminishing the opportunity to
trigger competition.”

Jenny Alltoft, head of global biosimilars at Pfizer, highlighted the cost,
in both cash and time, of developing a biosimilar. “Biosimilars aren’t like
small molecule generics, you’re talking about eight to nine years to
develop them to bring them to market and $100m to $200m of investment;
[versus] a small molecule which is more of a one to three years and more
into the low single-digit millions to bring them to market,” she said.

Carol Lynch, global head of biopharmaceuticals at Sandoz, said that between
2017 and 2020 the company will launch five biosimilars, mostly in
immunology and oncology.

“You’re always following the loss of exclusivity of the asset, and by 2020
seven of today’s top 10 selling products worldwide will have lost
exclusivity” with sales that add up to “around $100bn globally”.

Mr Harchowal said the relationship it had forged with Sandoz had opened up
an entirely new way of working with drugmakers.

It had shown “how we can work differently with the pharmaceutical industry
to help [create], not just a mutually beneficial situation, but . . .
something that has a countrywide, national impact”.

--

Newcomers to the field
The prospect of making money from biosimilars is attracting industry
players ranging from traditional pharma giants to companies more usually
associated with other industries.

Murray Aitken, executive director of the IQVIA Institute for Human Data
Science, which charts pharmaceutical industry trends, said the groups
looking to carve out a big slice of the biosimilars market were “a mix of
companies you recognise — Pfizer, Boehringer, Merck, Amgen and Sandoz — and
players that are not so familiar”.

He cited South Korea-based Celltrion, whose biosimilar version of Herceptin
was approved in Europe last year, along with companies he classes as
“newcomers” to the field: Russian biotech BIOCAD, Japan’s Fujifilm and
Poland’s Mabion.

Fujifilm has teamed up with a Japanese pharma company, Kyowa Hakko Kirin
Biologics, and said that, by merging technologies developed through its
photographic film business with Kyowa’s expertise in biopharma R&D and
manufacturing, it was able to produce “high-quality and cost-competitive”
biosimilars.

It has yet to launch a product but its application for authorisation of a
Humira biosimilar has been accepted by the European Medicines Agency and
last week it announced it had reached agreement with Mylan for the
exclusive commercialisation rights to this drug in Europe. A second
biosimilar is going through the final stage of trials.




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


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