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Goldman Sachs
Key Debates In Biosimilars Conference
Diem Nguyen
Regional President North America,
Global Established Pharmaceuticals
April 2, 2015
1
Forward Looking Statements
Our discussions during this presentation will include forward-looking statements about,
among other things, Pfizer’s biosimilars pipeline, including its potential benefits,
anticipated industry growth rates and Pfizer’s planned acquisition of Hospira, including its
potential benefits, and the combined company’s plans and prospects, that are subject to
substantial risks and uncertainties that could cause actual results to differ materially from
those expressed or implied by such statements. Additional information regarding these
factors can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2014 and in its subsequent reports on Form 10-Q, including in the sections
thereof captioned “Risk Factors” and “Forward-Looking Information That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the
SEC and available at www.sec.gov and www.pfizer.com. The forward-looking statements
in this presentation speak only as of the original date of this presentation and we
undertake no obligation to update or revise any of these statements.
2
Biosimilars: Attractive Growth Opportunity
3
Source: Decision Resources 2012 for US/EU5; ROW added based on assumed 30% of worldwide total
 >$100B of biologics lose patent protection in next 5-10 years
 Biosimilars are a potential lever to provide savings and efficiencies to healthcare systems as
well as to expand access in many markets to these important medicines
 Development, regulatory, and intellectual property pathways becoming more clear
$0.1 $1
$6$0.2
$1
$6
$0.0
$1
$8
2012 2015E 2020E
ROW EU5 US
<$1B
$3B
Biosimilars Marketplace, Gross Sales
$20B
What Biosimilars Are Not: Generics
• Proof of quality (identical chemical structure)
• Pharmacokinetic bioequivalence
• Relies on existing clinical data from reference
product’s label
• Proof of quality and similarity
• Pharmacokinetic bioequivalence
• Clinical data needed for biosimilar showing
comparable safety and efficacy
Small molecule
Biopharmaceutical
Generics
Biosimilars
4
The Potential of Biosimilars
1. Broadening access to important medicines: Biosimilars may expand the reach
of some of the world’s most important drugs, as they have the potential to increase
the ability of health care providers to deliver leading treatments to patients in need.
2. Driving innovative manufacturing: The manufacturing process for biosimilars is
highly sophisticated, requiring precision in process design and execution.
Manufacturers should possess state of the art analytical, technological and
managerial capabilities in order to produce these complex medicines.
3. Requiring uncompromising standards: Regulations should require high levels of
manufacturing excellence to ensure consistent production of high quality
medications that address patient needs.
5
“Because of their biologic complexity, mass producing these medicines calls for
a new approach to management and continuous improvement, which requires
the highest levels of attention to quality, precision and consistency.”
– David Niles, president, SSA & Company and Board Member, Deming Center at Columbia
Business School, Columbia University
Pfizer Point Of View: Patient Is At The Center. Policy Should
Be Established Based On Science And Physician Care
6
Regulatory
Framework
Naming
Interchangeability
Intellectual
Property
Approval and extrapolation should be based on the totality of data and the
demonstration of similarity in quality, clinical and non-clinical parameters
For biosimilars, reduced non-clinical and clinical development are enabled by
a successful early stage analytical comparison and demonstrating the biosimilar
is highly similar to the reference product
Interchangeability should be based on science and physician supervision
Biosimilars should have names (trade and generic) readily distinguishable from
the reference medicine to reflect their unique manufacturing processes
Innovators should be provided appropriate regulatory exclusivity to further biologics
development and to support the continued flow of innovative medicines
Any biosimilar approval process should allow for prompt resolution of
patent disputes
Labeling
Substitution
Sufficiently detailed and transparent labeling and product information will
enable informed decision making and help ensure appropriate use of biosimilars
Physicians should have the right to prescribe the medicine they feel is most
appropriate for their patients. Switching should remain a clinical decision to be
made by the treating physician
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  • 1. Goldman Sachs Key Debates In Biosimilars Conference Diem Nguyen Regional President North America, Global Established Pharmaceuticals April 2, 2015 1
  • 2. Forward Looking Statements Our discussions during this presentation will include forward-looking statements about, among other things, Pfizer’s biosimilars pipeline, including its potential benefits, anticipated industry growth rates and Pfizer’s planned acquisition of Hospira, including its potential benefits, and the combined company’s plans and prospects, that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Additional information regarding these factors can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the SEC and available at www.sec.gov and www.pfizer.com. The forward-looking statements in this presentation speak only as of the original date of this presentation and we undertake no obligation to update or revise any of these statements. 2
  • 3. Biosimilars: Attractive Growth Opportunity 3 Source: Decision Resources 2012 for US/EU5; ROW added based on assumed 30% of worldwide total  >$100B of biologics lose patent protection in next 5-10 years  Biosimilars are a potential lever to provide savings and efficiencies to healthcare systems as well as to expand access in many markets to these important medicines  Development, regulatory, and intellectual property pathways becoming more clear $0.1 $1 $6$0.2 $1 $6 $0.0 $1 $8 2012 2015E 2020E ROW EU5 US <$1B $3B Biosimilars Marketplace, Gross Sales $20B
  • 4. What Biosimilars Are Not: Generics • Proof of quality (identical chemical structure) • Pharmacokinetic bioequivalence • Relies on existing clinical data from reference product’s label • Proof of quality and similarity • Pharmacokinetic bioequivalence • Clinical data needed for biosimilar showing comparable safety and efficacy Small molecule Biopharmaceutical Generics Biosimilars 4
  • 5. The Potential of Biosimilars 1. Broadening access to important medicines: Biosimilars may expand the reach of some of the world’s most important drugs, as they have the potential to increase the ability of health care providers to deliver leading treatments to patients in need. 2. Driving innovative manufacturing: The manufacturing process for biosimilars is highly sophisticated, requiring precision in process design and execution. Manufacturers should possess state of the art analytical, technological and managerial capabilities in order to produce these complex medicines. 3. Requiring uncompromising standards: Regulations should require high levels of manufacturing excellence to ensure consistent production of high quality medications that address patient needs. 5 “Because of their biologic complexity, mass producing these medicines calls for a new approach to management and continuous improvement, which requires the highest levels of attention to quality, precision and consistency.” – David Niles, president, SSA & Company and Board Member, Deming Center at Columbia Business School, Columbia University
  • 6. Pfizer Point Of View: Patient Is At The Center. Policy Should Be Established Based On Science And Physician Care 6 Regulatory Framework Naming Interchangeability Intellectual Property Approval and extrapolation should be based on the totality of data and the demonstration of similarity in quality, clinical and non-clinical parameters For biosimilars, reduced non-clinical and clinical development are enabled by a successful early stage analytical comparison and demonstrating the biosimilar is highly similar to the reference product Interchangeability should be based on science and physician supervision Biosimilars should have names (trade and generic) readily distinguishable from the reference medicine to reflect their unique manufacturing processes Innovators should be provided appropriate regulatory exclusivity to further biologics development and to support the continued flow of innovative medicines Any biosimilar approval process should allow for prompt resolution of patent disputes Labeling Substitution Sufficiently detailed and transparent labeling and product information will enable informed decision making and help ensure appropriate use of biosimilars Physicians should have the right to prescribe the medicine they feel is most appropriate for their patients. Switching should remain a clinical decision to be made by the treating physician
  • 7. Pfizer Well Positioned to Be a Leader in Biosimilars Capabilities necessary for Biosimilars must span those required for innovative assets to those required for multi-source generics • Device options • Physician education • Patient support services • Robust efficacy / safety • Multiple disease states (if relevant) Physician / Patient Offerings Clinical Data Package • Payer mandates and contracting / tendering • Distributor agreements • Product+ offerings • Long-term data • Pharmacovigilance tracking • Phase IV data Post- marketing Data Access Agreements & Channel Services Biosimilar Penetration • Physicians and patients • Regulatory and policy • Payers and access issues Insights & Relationships • Biologics manufacturing, supply and product characterization • Drug delivery technologies • Commercialization (branded, off-patent) Expertise / Experience 7
  • 8. Pfizer Biosimilars Strategy: Investing In Hard-To-Make Monoclonal Antibodies 8 Oncology Inflammation Humira® (adalimumab) Remicade® (infliximab) Avastin® (bevacizumab) Herceptin® (trastuzumab) Potential Biosimilars in Development Herceptin® and Avastin® are registered U.S. trademarks of Genentech, Inc.; Rituxan® is a registered U.S. trademark of Biogen Idec Inc.; MabThera is a trademark of F. Hoffman-La Roche AG; Remicade® is a registered U.S. trademark of Janssen Biotech, Inc.; Humira® is a registered U.S. trademark of Abbvie Biotechnology Ltd.
  • 9. Key Takeaways 9  Biosimilars present a strong growth opportunity, with an expected market size of approximately $20Bn of gross sales by 2020*  The introduction of high quality, safe, and effective biosimilars has the potential to provide savings and efficiencies to healthcare systems and the potential to expand access to these important medicines in many markets  Biosimilars are complex, thus requiring commitment and unique capabilities to bring them to market  Adoption of biosimilars will depend on the evolving policy, payer, and regulatory landscape as well as physician and patient acceptance  Pfizer has a robust portfolio of biosimilars in development with strong R&D, manufacturing, and commercial capabilities with the potential to deliver quality biosimilars to physicians and patients globally *Source: Decision Resources 2012 for US/EU5; ROW added based on assumed 30% of worldwide total
  • 10. Goldman Sachs Key Debates In Biosimilars Conference Q&A Session April 2, 2015 10