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Expanding Sandoz
leadership in biosimilars
Carol Lynch, Global Head of Biopharmaceuticals, Sandoz
Schaftenau, Austria
June 17, 2016
Sandoz
Biopharmaceuticals
Sandoz Biopharmaceuticals
Patients with moderate-to-
severe psoriasis receiving
biologic medicines1
~5%
Patients with cancer in the
US cannot afford to pay for
their treatment 2
Patient access to biologics remains
a key healthcare challenge
Expanding Sandoz Leadership in Biosimilars2
25%
1. Ref: Nast A, et al. Arch Dermatol Res 2013;305(10):899–907
2. Financial toxicity in adults with cancer: Adverse outcomes and potential areas of intervention (ASCO 2016)
Sandoz Biopharmaceuticals
• Spending on specialty products
continues to rise
• Today, high cost is a major
barrier to access
• Several important biologics
going off-patent by 2020
• Biosimilars play an essential
role in providing cost relief to
healthcare systems while
increasing patient access
Biosimilars can provide needed
cost relief for healthcare systems
Business Use Only3
Top 10 selling
pharmaceuticals
2015 Rev.
(USD bn)
Costs2 per
patient per
month
1. HUMIRA®
14.4 1,200
2. HARVONI®
13.8
3. ENBREL®1
9.0 1,150
4. REMICADE®
8.1 8003
5. RITUXAN®
7.3
6. LANTUS®
7.1
7. AVASTIN®
6.9 5,200
8. HERCEPTIN®
6.8 2,600
9. PREVNAR 13 6.0
10. REVLIMID®
5.8
Loss of exclusivity by 2020
1. Enbrel patent exclusivity loss in the US in period until 2020 dependent on validity of submarine patents that may hold in US until 2028
2. EU5 average, based on list price 3 Excluding facility costs
Note: All trademarks are the property of their respective owners
Source: Evaluate Pharma analysis January 2016
Sandoz Biopharmaceuticals
US, immunology therapies expected
to drive dramatic market expansion
Business Use Only4
1. Compound Annual Growth Rate
2. Source: EvaluatePharma, IMS, Market Reports, Sandoz
0.7
+35%
2020
14
2015
1
2013
Rest of worldEUUS
+50%
+50%
+90%
+62%
0.7
+35%
2020
14
2015
1
2013
+142%
+35%
N/A
Oncology
EPO, G-CSF, hGH
Insulins
Immunology
Other
+92%
CAGR1
2015-20
CAGR1
2015-20
Biosimilar market by geography
USD billion
+62%
Biosimilar market by segment
USD billion
Sandoz Biopharmaceuticals
Stakeholder environment
increasingly supportive
Key recent positive developments
Business Use Only5
Focus areas
Regulatory
• First biosimilar approved
and launched under new
regulatory pathway
• Non-discriminatory guidance
on INN
• “Same-label” approach to
biosimilar labels
Legal
• Initial clarification on BPCIA1
Physician acceptance
• Physicians accept biosimilar
concept in supportive care
Regulatory
• Two biosimilar mAbs2
approved and launched
• Accelerated EMA approvals
Policy
• Several governments
support physician-driven
switching
Physician acceptance
• Growing acceptance
biosimilar extrapolation in
immunology
• Biosimilar Concept
Education: immunology
and oncology HCPs and
patients
• Sustainable
Market Policies:
Sustainable procurement
and prescribing incentives
(CMS ruling, Nordics
pricing)
• Reduce legal and
regulatory uncertainties:
Notice of commercial
marketing and IP (mainly in
US)
1. Biologics Price Competition and Innovation Act; litigation ongoing
2. Monoclonal antibody
Sandoz Biopharmaceuticals
Competitive environment is
dynamic – not everyone will win
Expanding Sandoz Leadership in Biosimilars6
Evolution of competitive landscape
Before 2015 2015 and after Key competitors are
partnering for:
• Commercial
capabilities
• Generic
capabilities
• Financial
resources
• Clinical expertise
• Manufacturing
networksOther
competitors
Sandoz Biopharmaceuticals
Sandoz has sustained leadership
with growth accelerating
Business Use Only7
2011 2012 2013 2014 2015 Q1 2016
Sandoz Biopharmaceuticals third-party sales1
USD million at actual rates
+23% cc
214
50% cc
growth
All three in-line
brands continue to
grow double-digit
Launched first
biosimilar in EU,
Japan and US
Leading role in
shaping regulatory
and policy
environment
1. Includes biosimilars, industrial manufacturing and GlatopaTM
2. Under new regulatory pathway
772m
Sandoz Biopharmaceuticals
Sandoz is aiming to launch five
biosimilars in EU and US by 2020
Expanding Sandoz Leadership in Biosimilars8
Six out of 11 filings1 completed
Molecule2 Agency Filing
FDA 2015 
EMA 2015 
FDA 2015 
EMA 2015 
EMA
2015 
(approved)
EMA 2016 
FDA 2016
FDA 2016
EMA 2017
FDA 2017
EMA 2017
5
Launch
biosimilars of major
biologics going off patent
by 2020
In May, EMA accepted biosimilar rituximab for review
1. By 2017
2. All trademarks are the property of their owner
Sandoz Biopharmaceuticals
Committed to strengthening our
biosimilar portfolio
Expanding Sandoz Leadership in Biosimilars9
Oncology
Immunology &
other specialty
areas
Pursuing
partnerships to
strengthen the
pipeline (e.g.
infliximab, with
Pfizer) and access
geographies (e.g.
KHK Japan)
5+ 3+
Ensure leading
biosimilar pipeline to
sustain long term leadership position
#
Each year, new biosimilar programs are initiated
Number of biosimilar compounds
Sandoz Biopharmaceuticals
As Novartis, we will be able to
offer a broad treatment portfolio
Expanding Sandoz Leadership in Biosimilars10
Innovative medicines
• Etanercept
• Adalimumab
• Infliximab
• Rituximab
• Rituximab
• Peg-
filgrastim
Biosimilars Generics
60+
compounds
80+
compounds
OncologyImmunology
Physicians
Patients
Payors
Sandoz Biopharmaceuticals
Commercially, we are positioned to
win in diverse biosimilar markets
Expanding Sandoz Leadership in Biosimilars11
Examples
Physician-driven Payor-driven
Payer/PBM1/hospital
Physician
Physician field force and MSLs3
Payer liaison and KAM2
Agility and broad
capability set
required in diverse,
emerging
biosimilar space
As part of Novartis,
Sandoz has all
capabilities to
win in different
environments
1. Pharmacy-Benefit Manager
2. Key Account Management
3. Medical Science Liaisons
Key
influencer
Winning
approach
Sandoz Biopharmaceuticals
Access to industry-leading
capabilities across Novartis
Expanding Sandoz Leadership in Biosimilars12
• Industry-leading
capabilities in
Analytics and
Technical
Development
• Deep therapeutic
area expertise in
clinical development
• 35+ years
experience in
manufacturing
recombinant proteins
• State-of-the-art
capabilities across
microbial, cell culture
& fill/finish
Development
• Strong
relationships with
regulatory agencies
along all pathways
• Proven ability to
shape market
environments
Regulatory & policy Manufacturing
USD 1 billion in manufacturing related investments in Austria (2010-2020)
Sandoz Biopharmaceuticals
Biosimilars could have a
transformational impact on care
Expanding Sandoz Leadership in Biosimilars13
Biosimilars can help broaden access to high-
quality biologics that have a significant impact on
patients’ lives
Sandoz expects to see significant growth with five
major biosimilar launches across geographies
Biosimilars provide payers with an important
solution to help manage the rising cost of
healthcare and sustain medical innovation
Thank you

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Expanding Sandoz leadership in biosimilars

  • 1. Expanding Sandoz leadership in biosimilars Carol Lynch, Global Head of Biopharmaceuticals, Sandoz Schaftenau, Austria June 17, 2016 Sandoz Biopharmaceuticals
  • 2. Sandoz Biopharmaceuticals Patients with moderate-to- severe psoriasis receiving biologic medicines1 ~5% Patients with cancer in the US cannot afford to pay for their treatment 2 Patient access to biologics remains a key healthcare challenge Expanding Sandoz Leadership in Biosimilars2 25% 1. Ref: Nast A, et al. Arch Dermatol Res 2013;305(10):899–907 2. Financial toxicity in adults with cancer: Adverse outcomes and potential areas of intervention (ASCO 2016)
  • 3. Sandoz Biopharmaceuticals • Spending on specialty products continues to rise • Today, high cost is a major barrier to access • Several important biologics going off-patent by 2020 • Biosimilars play an essential role in providing cost relief to healthcare systems while increasing patient access Biosimilars can provide needed cost relief for healthcare systems Business Use Only3 Top 10 selling pharmaceuticals 2015 Rev. (USD bn) Costs2 per patient per month 1. HUMIRA® 14.4 1,200 2. HARVONI® 13.8 3. ENBREL®1 9.0 1,150 4. REMICADE® 8.1 8003 5. RITUXAN® 7.3 6. LANTUS® 7.1 7. AVASTIN® 6.9 5,200 8. HERCEPTIN® 6.8 2,600 9. PREVNAR 13 6.0 10. REVLIMID® 5.8 Loss of exclusivity by 2020 1. Enbrel patent exclusivity loss in the US in period until 2020 dependent on validity of submarine patents that may hold in US until 2028 2. EU5 average, based on list price 3 Excluding facility costs Note: All trademarks are the property of their respective owners Source: Evaluate Pharma analysis January 2016
  • 4. Sandoz Biopharmaceuticals US, immunology therapies expected to drive dramatic market expansion Business Use Only4 1. Compound Annual Growth Rate 2. Source: EvaluatePharma, IMS, Market Reports, Sandoz 0.7 +35% 2020 14 2015 1 2013 Rest of worldEUUS +50% +50% +90% +62% 0.7 +35% 2020 14 2015 1 2013 +142% +35% N/A Oncology EPO, G-CSF, hGH Insulins Immunology Other +92% CAGR1 2015-20 CAGR1 2015-20 Biosimilar market by geography USD billion +62% Biosimilar market by segment USD billion
  • 5. Sandoz Biopharmaceuticals Stakeholder environment increasingly supportive Key recent positive developments Business Use Only5 Focus areas Regulatory • First biosimilar approved and launched under new regulatory pathway • Non-discriminatory guidance on INN • “Same-label” approach to biosimilar labels Legal • Initial clarification on BPCIA1 Physician acceptance • Physicians accept biosimilar concept in supportive care Regulatory • Two biosimilar mAbs2 approved and launched • Accelerated EMA approvals Policy • Several governments support physician-driven switching Physician acceptance • Growing acceptance biosimilar extrapolation in immunology • Biosimilar Concept Education: immunology and oncology HCPs and patients • Sustainable Market Policies: Sustainable procurement and prescribing incentives (CMS ruling, Nordics pricing) • Reduce legal and regulatory uncertainties: Notice of commercial marketing and IP (mainly in US) 1. Biologics Price Competition and Innovation Act; litigation ongoing 2. Monoclonal antibody
  • 6. Sandoz Biopharmaceuticals Competitive environment is dynamic – not everyone will win Expanding Sandoz Leadership in Biosimilars6 Evolution of competitive landscape Before 2015 2015 and after Key competitors are partnering for: • Commercial capabilities • Generic capabilities • Financial resources • Clinical expertise • Manufacturing networksOther competitors
  • 7. Sandoz Biopharmaceuticals Sandoz has sustained leadership with growth accelerating Business Use Only7 2011 2012 2013 2014 2015 Q1 2016 Sandoz Biopharmaceuticals third-party sales1 USD million at actual rates +23% cc 214 50% cc growth All three in-line brands continue to grow double-digit Launched first biosimilar in EU, Japan and US Leading role in shaping regulatory and policy environment 1. Includes biosimilars, industrial manufacturing and GlatopaTM 2. Under new regulatory pathway 772m
  • 8. Sandoz Biopharmaceuticals Sandoz is aiming to launch five biosimilars in EU and US by 2020 Expanding Sandoz Leadership in Biosimilars8 Six out of 11 filings1 completed Molecule2 Agency Filing FDA 2015  EMA 2015  FDA 2015  EMA 2015  EMA 2015  (approved) EMA 2016  FDA 2016 FDA 2016 EMA 2017 FDA 2017 EMA 2017 5 Launch biosimilars of major biologics going off patent by 2020 In May, EMA accepted biosimilar rituximab for review 1. By 2017 2. All trademarks are the property of their owner
  • 9. Sandoz Biopharmaceuticals Committed to strengthening our biosimilar portfolio Expanding Sandoz Leadership in Biosimilars9 Oncology Immunology & other specialty areas Pursuing partnerships to strengthen the pipeline (e.g. infliximab, with Pfizer) and access geographies (e.g. KHK Japan) 5+ 3+ Ensure leading biosimilar pipeline to sustain long term leadership position # Each year, new biosimilar programs are initiated Number of biosimilar compounds
  • 10. Sandoz Biopharmaceuticals As Novartis, we will be able to offer a broad treatment portfolio Expanding Sandoz Leadership in Biosimilars10 Innovative medicines • Etanercept • Adalimumab • Infliximab • Rituximab • Rituximab • Peg- filgrastim Biosimilars Generics 60+ compounds 80+ compounds OncologyImmunology Physicians Patients Payors
  • 11. Sandoz Biopharmaceuticals Commercially, we are positioned to win in diverse biosimilar markets Expanding Sandoz Leadership in Biosimilars11 Examples Physician-driven Payor-driven Payer/PBM1/hospital Physician Physician field force and MSLs3 Payer liaison and KAM2 Agility and broad capability set required in diverse, emerging biosimilar space As part of Novartis, Sandoz has all capabilities to win in different environments 1. Pharmacy-Benefit Manager 2. Key Account Management 3. Medical Science Liaisons Key influencer Winning approach
  • 12. Sandoz Biopharmaceuticals Access to industry-leading capabilities across Novartis Expanding Sandoz Leadership in Biosimilars12 • Industry-leading capabilities in Analytics and Technical Development • Deep therapeutic area expertise in clinical development • 35+ years experience in manufacturing recombinant proteins • State-of-the-art capabilities across microbial, cell culture & fill/finish Development • Strong relationships with regulatory agencies along all pathways • Proven ability to shape market environments Regulatory & policy Manufacturing USD 1 billion in manufacturing related investments in Austria (2010-2020)
  • 13. Sandoz Biopharmaceuticals Biosimilars could have a transformational impact on care Expanding Sandoz Leadership in Biosimilars13 Biosimilars can help broaden access to high- quality biologics that have a significant impact on patients’ lives Sandoz expects to see significant growth with five major biosimilar launches across geographies Biosimilars provide payers with an important solution to help manage the rising cost of healthcare and sustain medical innovation