expanding sandoz leadership in biosimilars

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)


• 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


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

2013Rest 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 geographyUSD billion

+62%

Biosimilar market by segmentUSD billion


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


Competitive environment is

dynamic – not everyone will win


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 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 is aiming to launch five

biosimilars in EU and US by 2020


Six out of 11 filings1

completed

Molecule2 Agency Filing

FDA 2015

EMA 2015

FDA 2015

EMA 2015

EMA2015

(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


Committed to strengthening our

biosimilar portfolio


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


As Novartis, we will be able to

offer a broad treatment portfolio


Innovative medicines

• Etanercept

• Adalimumab

• Infliximab

• Rituximab

• Rituximab

• Peg-

filgrastim

Biosimilars Generics

60+

compounds

80+

compounds

On

co

log

yIm

mu

no

log

y

Physicians

Patients

Payors


Commercially, we are positioned to

win in diverse biosimilar markets


Examples

Physician-driven Payor-driven

Payer/PBM1/hospitalPhysician

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


Access to industry-leading

capabilities across Novartis


• 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)


Biosimilars could have a

transformational impact on care


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

expanding sandoz leadership in biosimilars

Health & Medicine