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

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The Biosimilar Market Leader’s Perspective

  • 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