1. Analysing the market
CPhI Worldwide Pre-Show Conference
CPhI Paris
4th October 2010
Peter Wittner
Interpharm Consultancy
Biosimilars - will they be worth the effort?
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2. Analysing the market
Understanding what makes Biosimilars uptake more
difficult than generics
Interchangeability – the big hurdle
What is the size of the pie? Analysing growth statistics
and explaining the gap in performance versus potential
Biotech market is booming but Biosimilars are
lagging behind
Identifying the key therapeutic areas for Biosimilars
Do the numbers tell us the whole story?
Where are the future opportunities for greatest growth?
US, EU or India?
Where should you invest?
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3. What makes Biosimilars uptake
more difficult than generics?
Interchangeability – the big hurdle
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4. What is the size of the pie?
i lar
sim ce
io l i
B s
How big will the Biosimilars slice be?
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6. What is the size of the pie?
Biotech market value is mainly concentrated in
Western markets............
Biological products 2009
$5.0 Sales in $b n. Source: IMS Europe
$4.5 US
$4.0 $2.0
$1.4 $1.5
$3.5 $2.0 $1.6 $1.5
$3.0 $1.0
$2.5
$2.0
$1.5 $3.0 $3.0 $2.8 $2.6 $2.5 $2.4
$2.3
$1.0
$0.5
$0.0
Enbrel Remicade Avastin Humira Lovenox Mabthera Lantus
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7. What is the size of the pie?
.... but most of world population and the Biosimilar
consumer base is in low-cost developing markets
W orld population breakdown
14.8% 0.5% 8.7%
5.0%
3.1%
11.9%
56.0%
A frica A sia E uro p e M iddle E ast
N o rt h A m erica L at in A m erica Ocean ia / A ust ralia
/Caribbean
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8. Why is the biological market growing?
Big Pharma is moving up market
Biologicals are higher priced than small molecule
medicines
Biologicals are harder to copy = technological barrier
Biologicals pricing – some US figures from GPhA
In the US the lung cancer drug Avastin costs about
$100,000 per patient per year
The cost for Cerezyme used to treat Gaucher disease,
can run to $300,000 / patient / year
Projected savings are between $42- $108 bn over the
first 10 years of a US Biosimilar market
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9. What makes Biosimilars uptake
more difficult than generics?
Let’s compare with normal generics
Look at what will certainly happen with Atorvastatin
The SPC expires November 2011
Based on precedent, around 20 companies will launch on
the day after the expiry
All will have been accepted as “essentially similar” to
Lipitor by the regulators
All can therefore be substituted in place of the original
brand and each other
In other words, there is complete interchangeability
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10. Interchangeability – why is it an issue?
Marketing biosimilars is not the same as
marketing generics
The big issue is interchangeability
Or perhaps the real issue is the lack of it
Prescribers need to be convinced that A = B or
else they will not substitute when prescribing
If Biosimilars cannot be prescribed by INN
name, the pharmacist cannot substitute
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11. What makes Biosimilars uptake
more difficult than generics?
Interchangeability – experience in EU markets
shows that prescribers are reluctant to switch
Most EU countries require prescription of biological
products by brand name
Prescribers are therefore waiting until they see a
newly diagnosed patient before trying Biosimilar
Result – very slow market penetration by
Biosimilars
Amgen claims it has only lost 3% MS to Filgrastim
(G-CSF) copies
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13. What has happened so far?
“Bringing a Biosimilar to market takes up
to eight years, with development costs
averaging $100-$150 million.
Last year, sales of biosimilars reached just
$75 million worldwide compared with
$110 billion in sales of biologic drugs”
Greg Perry, EGA, speaking at 8th EGA International Symposium on Biosimilar
Medicines, 2nd September 2010 reported by Pharma Times
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14. Biosimilars marketplace
Who will be the major players?
In Western markets.....
Only companies with deep pockets!
Biosimilars have to be marketed, not just sold
That means Teva, Sandoz, Hospira
In Eastern and emerging markets
The barriers to entry are lower
The market is more a classic generic market -
PRICE!
Ranbaxy, Dr. Reddys, Biocon are already there
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15. Biosimilars marketplace
It is not just the generic companies that are
thinking about entering the market
2008 – Merck & Co announces plans for unit to
copy biotech medicines. Aim is to sell at least six
biogenerics by 2017
2009 – Eli Lilly acquires Imclone Systems and
announces initiative to develop biosimilars
2009 – AstraZeneca says it is considering
participation in biosimilars market
Jan 2010 – Pfizer says it plans to launch
biosimilars of leading 10–15 biologicals
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16. Biosimilars – Big Pharma
Pfizer wants to enter China using locally made
copy biologicals with Pfizer / Wyeth brand
GSK will buy biosimilars from Biocon (India) for
Pharmerging markets
Sanofi-Aventis is also planning to target
Pharmerging markets with Biosimilars
Bayer-Schering is selling Gensulin from Bioton
(Poland) and Insugen from Biocon in China
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17. Key therapeutic areas for
Biosimilars
This is another area where market figures alone
will not be a good guide
Market data seems to show MAbs taking a
growing market share
But what data will the regulators want to
allow you to register your copy?
The rate limiting step in regulated markets is going
to be the need for regulators to provide guidelines
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18. Where are the future opportunities
for greatest growth?
US, EU or India?
US biological prices are under pressure but should
stay high
EU – price competition is growing
More Biosimilars entering the market and slow
uptake will inevitably push prices down
India – low prices
But market entry is easier and volumes are huge
Where should you invest?
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19. Asian markets – India
Changes in G-CSF (Filgrastim) prices in
response to competition
6,000
5,000
4,000
R Inno vato r
u Bio similar
p
e 3,000
e
s
2,000
1,000
0
2002 2003 2004 2005 2006 2007 2008
Source: Biocon presentation, Biosimilars India 2009
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20. Asian markets – India
Comparing Indian Biological prices to the rest of the world
Substance Average Average Differential
world price Indian price in %
Human Insulin U$ / 100 IU vial US$6.50 / 100 IU
vial 80%
Anti-EFGR $25,000 per $6,000 per
Monoclonal treatment treatment 75%
Recombinant
streptokinase
$150 / vial $10 / vial 95%
EPO $200 / 2,000 IU $10 / 2,000 IU 95%
Source: Biocon (Biosimilars India 2009)
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21. Where are the future opportunities
for greatest growth?
So where should you invest?
India / Asia / Latin America for quick returns
Market entry is quicker and cheaper, prices are
lower, but compensation is the high volumes
EU/USA for longer term stability and higher
margins
Market entry is slower and much more costly, but
the compensation will be long-term stability and
higher prices
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