At least 400 million people worldwide lack access to essential health services and 2 billion cannot afford the medicines they need. Meanwhile, the global cost of healthcare has jumped to 6.5 trillion US dollars. Access is a huge and complex issue, which affects both developing and developed countries. Today Carol Lynch, our Global Head of Biopharmaceuticals, gave a keynote address to the European Biosimilars Group highlighting how biosimilars can help transform patient outcomes and calling for all stakeholders to work together to build trust and confidence. You can read the presentation here

1. The Biosimilar Market Leader’s Perspective
Carol Lynch, Global Head of Sandoz Biopharmaceuticals
April 28, 2016

2. 2 | Medicines for Europe Biosimilars Conference | April 2016
10 years on, biosimilars have had a strong impact on
global healthcare
20+
 Products approved by the
European Medicines Agency
over 10 years1
Product Approvals
551M€
 Estimated cumulative
savings from biosimilars
epoetins in Germany
2007-20114
Healthcare system
savings
104%
 Increase in standard units of
filgrastim in the UK from
2008-2014 (post biosimilar
launch)5
Increased patient
access
+50%
 Market share for biosimilar
G-CSF2
Market Acceptance
+250m
 Patient days of safe clinical
experience with Sandoz
biosimilars alone3
Patient Experience
1. European Medicines Agency Website
2. IMS MIDAS
3. Sandoz Product Safety Update Report (accessed October 2015)
4. IMS Institute for Healthcare Informatics: Assessing biosimilar uptake and competition in European markets. Date of Report: Oct 2014.
5. IMS Institute for Healthcare Informatics: Delivering on the Potential of Biosimilar Medicines. Date of Report: Mar 2016.

3. 3 | Medicines for Europe Biosimilars Conference | April 2016
However, the status quo must change for biosimilars
to deliver on its promise
Strategic ImperativesCritical Challenges
Build Trust &
Confidence
Ensure Sustainable
Market Policies
Clarify Legal and
Regulatory Uncertainties
1. Stakeholder understanding
and acceptance
2. Disproportionate focus on
acquisition costs
3. Continued legal and regulatory
uncertainties (mainly in US)

4. 4 | Medicines for Europe Biosimilars Conference | April 2016
Recent US and EU biosimilar launches indicate
progress in building stakeholder acceptance.....
Physicians accept
biosimilar concept –
in acute care
settings
Economic value
recognized by payors
& healthcare providers
Pre-launch educational
efforts across
stakeholders helped
address key concerns
Source: IMS Pharmascope
1 Community medical center: MVZ in Germany, therefore, possible multiple specialties are included
0
5
10
15
20
25
21%
17%
Jan-15
5%
1%
6%
4%
15%
3%
Jun-15
1%
12%
1%
0%
11%
12%
2%
Apr-15
9%
Feb-15 MAR/15
6%
12%
4%
MAY/15
6%
0%
1%
0%
17%
4%
Others
Derma
GPs/community medical centers
Rheuma
Total Biosimilar penetration
Gastro
Filgrastim US Infliximab EU5
Prescriptions(in%)

5. 5 | Medicines for Europe Biosimilars Conference | April 2016
....However, all stakeholders must contribute to
improving trust and confidence in biosimilars
Payors: Support biosimilar
education amongst HCPs
Patient Groups: Develop
and share educational
content for patients
HCPs: Deepen
understanding of
biosimilars and help
reassure patients
Manufacturers: Ensure
availability of science-based
information on biosimilars
Govt: Continue to
highlight societal value of
biosimilars across
stakeholders
Regulators: Engage with
HCPs on robustness of
regulations/extrapolation
Increasing
adoption of
biosimilars
Collectively address the scourge of misinformation

6. 6 | Medicines for Europe Biosimilars Conference | April 2016
Considerable variation across the EU exists in terms of
payer policy approaches to biosimilars
Many patients
available for
manufacturers
to compete for
Most patients
out of reach for
manufacturers
 National management passive (i.e.
fixed biosimilar price reduction)
 No prescribing incentives
 No prescription quota
 Increased active management
nationally
 Education of physicians by payers
 Biosimilar prescribing stimulated
(quotas)
Competition averse Foster competition
Source: Adapted from IMS Health, IMS Consulting Group, March 2016

7. 7 | Medicines for Europe Biosimilars Conference | April 2016
Healthcare systems must advance policies that
ensure sustainability
Sustainable
Procurement
 No “winner takes all
tenders”
 Acknowledge that
biosimilars are not
generics: no
mandatory price cuts
 Promote fair
competition and level-
playing field
Prescribing Incentives
 “Gain-sharing” that
helps hospitals to
benefit from savings
 Quotas to create
competition while
retaining prescriber
choice
 Support acquisition of
most cost-effective
medication by
hospitals

8. 8 | Medicines for Europe Biosimilars Conference | April 2016
Legal and regulatory clarity essential for further
development of the biosimilars industry
Maintain established
regulatory
framework
BPCIA Ambiguities
INN & Labeling
Interchangeability

9. 9 | Medicines for Europe Biosimilars Conference | April 2016
Collectively, we can ensure biosimilars play an even
more transformational role in global healthcare
49-98B€
 Expected cumulative savings from
biosimilars 2016-2020 in US+EU51
Generate savings for
healthcare systems
~5%
 Patients with moderate-to-severe
psoriasis receiving biologic
medicines2
Improve patient access
1. IMS Institute for Healthcare Informatics: Delivering on the Potential of Biosimilar Medicines. Date of Report: Mar 2016.
2. Ref: Nast A, et al. Arch Dermatol Res 2013;305(10):899–907