1

2

The EU Market Environment for

Biosimilar Medicines

12th Annual IGPA Conference

Sep 30-Oct 2, 2009

Montreal

Suzette KoxSenior Director Scientific Affairs

European Generic medicines Association

3

Outlines

Definitions/terminologies in the EU context

EU biosimilar market environment

Regulatory framework

Supply

Demand

EGA Vision: global development

4

Definitions (1)

Biosimilar Medicines

Within EU: Approved according to EU legislation

Outside EU: approved on the basis of equivalent

standards to the EU

A biosimilar medicine has shown to have a

comparable quality/safety/efficacy profile to the

reference product and is therefore qualified for

therapeutic interchangeability with the reference

product

5

Definitions (2)

Interchangeability (Ability to

interchange)

Refers to the medical practice of changing

one medicine for another that is equivalent

in a given clinical setting on the initiative or

with the agreement of the prescriber

6

Definitions (3)

Substitutability (Ability to substitute)

Refers to the practice of dispensing one

medicine instead of another equivalent

medicine at the pharmacy level without

requiring consultation with the prescriber

Substitution is either allowed, required or

excluded according to national or local rules

7

Definitions (4)

Automatic Substitution

Refers to the practice whereby a pharmacist

is obliged to dispense one medicine instead

of another equivalent medicine due to

national or local requirements

8

Understand the Market

Environment for Biosimilar

Medicines...

Supply

Regulatory

environ

ment

Demand

Bio-

similar

Market

9

Understand the Market

Environment for Biosimilar

Medicines...

Supply

Regula-

tory

environ-

ment

Demand

Bio

similar

Market

10

Consolidation of

EU ‘Biosimilar Thinking’

Further consolidation in 2008/9

EU continues to lead worldwide in developing guidelines and inspiring ROW

New mile stone in 2009:

EMEA Biosimilar Monoclonal Antibodies (mAbs) workshop (2 July 2009)

mAbs: key for patient access and the sustainability of the biosimilar medicines industry

11

Safe and Secured Environment

Company must have a risk-management

system in place before approval

ie a set of pharmacovigilance activities and

interventions designed to identify,

characterise, prevent or minimise risks

European Commission new

pharmacovigilance legislative proposal

12

G.Lalis/Director General EC on Pharmacovigilance for Biosimilars

EGA Annual Conference Paris 6/08

13

Reported ADRs Assigned to the

Right Product

EU legal obligation:

An adverse reaction report for any

biological drug should always include

– full name of the biological drug

– batch number

Where information is missing, Member

States/MAHs should ensure that reports

are followed up for completion

14

Impact on Prescribing and

National Substitution Policies

Biosimilar medicines are prescribed by brand names (INN-MAH/trademark or invented name)

Interchangeability takes place

eg. all biologicals excluded from substitution in Spain; no biosimilar substitution list in France

No automatic substitution for biologicals in the EU

15

Understand the Market

Environment for Biosimilar

Medicines...

Supply Regulatory

environ

ment

Demand

Bio

similar

Market

16

Our Industry is Delivering

13 Products (6

developments)

Somatropin(2)

Epoetin(5)

Filgrastim (6)

Withdrawl/rejection

Interferon alfa (1)

Insulin (3)

17

Positive Trend of Biosimilar

Applications Continues

3

0

4

10

3

8

0

2

4

6

8

10

12

2004 2005 2006 2007 2008 2009

Yea rNu

mb

er

bio

sim

ila

r a

pp

lic

ati

on

s f

or

init

ial

ev

alu

ati

on

Source: EGA graph based on figures published in the EMEA Annual Work Programmes

18

18

Increase of Scientific Advice

Biosimilar Scientific Advice (Mar 2009)

0

2

4

6

8

10

12

14

16

18

2003 2004 2005 2006 2007 2008 2009

Year

Nu

mb

er

of

ap

pli

cati

on

s

Follow up advice

First advice

Source/EMEA presentation slide/ T. Lönngren/ 24.4.09 EGA symposium on biosimilar medicines

19

Understand the Market

Environment for Biosimilar

Medicines...

Supply

Regulatory

environ

ment

Demand

Bio

similar

Market

20

Positive Developments

in the Market Place

EU clinical experience of

biosimilar products continues to grow

Market inroads are made

Biosimilar medicines industry very

confident about the future

21

Denigration of Biosimilar Products

Highlighted by the Mutualité Française

‘In the context of its sector inquiry, the French Mutuality asks the European Commission to mention the denigration campaigns put in place by originator companies with the aim of maintaining an aura of suspicion around biosimilars. Indeed originator companies spread alarmist and often worrisome news regarding the difficulty of reproducing biotechnology derived products’.

(Public submission sector inquiry-EGA internal translation)

22

Building Trust: Industry-

Regulator Cooperation

Challenging

misinformation,

misinterpretation,

misperceptions

= shared responsibility

by industry and

regulators for the

sake of patients

23

EGA Vision to Increase Access

to High Quality

Affordable Biotech Medicines

24

EU legal framework

firmly established

USA Legislation

expected soon

JP Final guideline

released on March 4,

2009

Australia EU guidelines

adopted

EU Inspiring the Rest of the World

Towards Harmonisation of Requirements

Canada

WHO draft guidance to

be finalised end 09

Taiwan

Malaysia

Argentinia

Columbia

Turkey

Venezuela

Mexico

Brazil

Japan

India

Saudi-Arabia

Source: Sandoz

25

JP US EU Requirements

√ √ √

rigorous physicochemical and biological comparison

with reference product of different regions

√ √ √

appropriate comparative pre-clinical testing with

reference product of different regions in case of

physico-chemical differences shown between drugs

√ √√ rigorous comparative PK/PD clinical phase I studies

with reference product of different regions

comparative clinical phase III studies with reference

product from one region only

(against either EU reference product or US reference

product)

Global Development Based on a Stepwise

Approach to Demonstrating Comparability of

Reference Products and Biosimilar

√Source: Sandoz

26

Global Development

for Biosimilar Medicines

Streamlining the development processAvoids repetition of unnecessary trials

Increases competition which will stimulate the

discovery of new live saving medicines

Is a must to remain competitive and financially

viable

Is crucial to ensure worldwide availability,

affordability and patient access to biotech

medicines

27

Thank you very much

28

Acronyms

EGA European Generic medicines Association

EU European Union

WHO World Health Organization

ROW Rest of World

MAA Marketing Authorisation Application

MAH Marketing Authorisation Holder

INN International Non-Proprietary Name

ADR Adverse Drug Reaction

RMP Risk Management Plan