BIOSIMILARS - Regulation and Market Trends

1
BIOSIMILARS
--------------------
Regulation, Market Trends
AND
Originators strategy
Joseph Pategou
International Strategy and Influence
joseph.pategou@skema.edu

23/05/2016 Regulatory issues on the development of Biosimilars – Joseph Pategou 2
SUMMARY
Executive Summary
Introduction
I. Methodology
II. Global economic situation
III. Regulation and market trends of Biosimilars
IV. Strategic positioning for Originators
Conclusion
Information about the author
Appendix

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EXECUTIVE SUMMARY: 7 Key Points
Regulatory issues on the development of Biosimilars – Joseph Pategou
 Reduction of health spending in OECD countries
 Clear difference between Biosimilars and Generics
 EU: the most advanced market for Biosimilars
 Substitution and interchangeability are great issues for all actors
 Germany: the most favorable regulation for Biosimilars
 Regulation issues on Biosimilars evolve quickly
 10 levers of Originators to face Biosimilars

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INTRODUCTION

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Introduction to Biosimilars
 A Biosimilar is a biological medicine that is similar to, but not identical to,
another biological medicine that has already been approved
 Due to its complex molecular structure and unique manufacturing
process, a Biosimilar is not a copy of its originator biologics
 Concept of a “similar biological medicinal product” was adopted in EU
pharmaceutical legislation in 2004
 EU is the first region in the world to have set up a legal framework and a
regulatory pathway for Biosimilars
 EU regulatory framework inspired many countries(Australia, Canada,
Japan, USA)
Source: Directive 2001/83/EC, as amended by Directive 2003/63/EC and Directive 2004/27/EC

Which regulatory framework for
Biosimilars in Europe?
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Research Question
What strategic positioning for the
Originator manufacturers?

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METHODOLOGY

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METHODOLOGY: 3 Steps
 Scope of the study: France, United Kingdom, Germany and Italy
1. Identify difference between Generics and Biosimilars
 Secondary data
2. Identify the position of main actors
 22 interviews
 4 types of organizations
 10 questions
 6 topics
3. Benchmarking
 13 companies
 Example: Amgen
 From 2000 to 2015
Sample of the interviews

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Source: Interview Bx: Biosimilars Unions
Sample of the Interviews
Types of Organizations Numbers
Unions 6 (Bx: 4)
Learned Societies 7
Patient Associations 3
Authorities 4
Others 2
LIEN HYPERTEXTE

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GLOBAL ECONOMIC
SITUATION

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ECONOMIC SITUATION: Reduction of health spending
 The total spending of health is declining since 2009 in OECD countries
 The most affected by the economic crisis are the main concerned for the
Panorama health 2013 of the OECD
 In this context, countries must make their health systems more:
 Productive
 Efficient
 Affordable
 Countries reduce spending:
 Lower prices of medical goods
 Budgetary restrictions
 Wage cuts in the hospital sector
 Example of France and Germany
12% 11%
Source: OECD

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REGULATION
Naming
Interchangeability
Substitution
SmPC
Extrapolation
Marketing Authorization
WHO
National Authorities
EMA
DECISION MAKER6 KEY TOPICS

 Suggestion of the World Health Organization:
 4-letter code at the end of every drug name
 Draft form (not implemented)
 Link to manufacturer and manufacturing site of the active substance
 All biologicals with INNs
 Example: “epoetin lambda bcde”
Position of the interviewees on Naming
 Difference of position:
 Right approach: BQ allows identification and traceability
 Wrong approach: BQ gives the perception of important differences between Biosimilar
and Originator
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Naming
DECISION MAKER
WHO
BQ: Biological Qualifier
Source: WHO
100% 100%
50%
50%
100%
0%
20%
40%
60%
80%
100%
Authorities Patient
Associations
Learned Societies Unions
Right approach
Wrong approach

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SmPC
 European Medicines Agency
 The SmPC of the Biosimilar product need to be consistent
with the SmPC of the reference product
 The SmPC must include the notion of Biosimilar and
a reference to the EMA website for further information
Position of the interviewees on SmPC
 Identical SmPC: No clinical differences between the Biosimilar and Originator
 Different SmPC : Will be of help and allow comparison
DECISION MAKER
EMA
Source: EMA
100%
33% 20%
80%67% 80%
20%
0%
20%
40%
60%
80%
100%
Authorities Patient
Associations
Identical SmPC
Different SmPC

 Substitution is the pratice of dispensing one medicine instead of another equivalent
and interchangeable medicine at the pharmacy level without consulting the prescriber
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Substitution
DECISION MAKER
National authorities
Country Substitution
United Kingdom Not authorized
France Decree Pending
Italy Not authorized
Germany Possible between Biosimilars
11%
89%
0%
20%
40%
60%
80%
100%
4MM
Substitution
No substitution
Position of the interviewees on
Substitution
 No substitution: The decision to treat a patient with a Biosimilar should be taken by a
qualified healthcare professional and the patient
4 MM: Masse Markets : Italy, UK, Germany and France
Position of each country on
Substitution
Source: See appendix

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Interchangeability
DECISION MAKER
National authorities Interchangeability: an important topic
 Interchangeability is the medical practice of changing one medicine for another that is
expected to achieve the same clinical setting and in any patient on the initiative, or with
the agreement of the prescriber
 Germany has accepted the principle of interchangeability, for the Paul-Ehrlich-Institute
“Biosimilar medicines can be prescribed to patients, who previously have not received
any treatment with biologics, as well as those patients who have previously received the
original molecule”
 In the United Kingdom, interchangeability is permitted for Biosimilars and rests with the
responsible clinician in consultation with the patient
 In France, interchangeability is permitted for Biosimilars and rests with the responsible
clinician in consultation with the patient (patient consent and clinical monitoring)
 Absence of interchangeability in Italy
 This situation will evolve due to the international context (scientific data available and
other countries)
Source: FDA

 European Medicines Agency
 Extrapolation is the scientific concept of granting a clinical indication to a medicine
without requiring new clinical efficacy and safety data to support an indication
 If Biosimilarity has been demonstrated in one indication, extrapolation to other
indications of the reference product could be acceptable with appropriate scientific
justification ( eg: clinical experience)
 Extrapolation: Biosimilars comparability has been demonstrated in one indication
 No extrapolation: Biosimilars are not identical to the Originators
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Extrapolation
DECISION MAKER
EMA
Position of the interviewees on Extrapolation
Source: EMA
100%
65% 60%
100%
35%
20%
0%
20%
40%
60%
80%
100%
Authorities Patient
Associations
Extrapolation
No extrapolation

Comparison of the MA between Originators, Generics, and Biosimilars
 Comparative studies in terms of :
 Quality
 Safety
 Efficacy
 Aim to demonstrate that these three parameters are similar to the Originator
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Marketing Authorization
File of the demand of MA Originators Generics Biosimilars
Module 1
Administrative Information
Yes Yes Yes
Module 2
Summary of Module 3, 4
and 5
Yes Yes Yes
Module 3
Quality (manufacturing
process)
Yes Yes Comparative studies
Module 4
Safety (non-clinical studies)
Yes Not required Comparative studies
Module 5
Efficacy (clinical studies )
Yes Bioequivalence Study Comparative studies
DECISION MAKER
EMA
Source: EMA

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Key Learnings
KEY POINTS DIFFERENCE IDENTICAL
Naming x
SmPC x
Substitution x
Marketing authorization x
Interchangeability x
The most favorable countries in terms of regulation
Germany 6 KEY TOPICS
United
Kingdom
6 KEY TOPICS
France 6 KEY TOPICS
Italy 6 KEY TOPICS
Comparison between Biosimilars and Generics
Favorable
Less favorable
 Germany has the most favorable regulation for biosimilars
 One commun point between Biosimilars and Generics regulation

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MARKET TRENDS

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Global Picture
Global market:
 2,6 billion$ in 2015
 25 billion$ in 2020
 Due to a new market
 Biosimilars sales by Region
First Biosimilar medicine approved by European Commission
Source: IMS and EGA
Focus on EU :
 Most advanced market
 11% of total biologics sales in 2011
 50% of the off-patent biological market in 2020
20 Biosimilars (7 actives substances) in 2015
Biosimilars market in volume and value in 2011

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Source: IMS
Anti-TNF, Insulins and Onco MABs are the key biologics
LIEN HYPERTEXTE

23/05/2016 23Regulatory issues on the development of Biosimilars – Joseph Pategou
Source: BioTrends Research Group A: Actual ; F: Forecast
$ billion
USA
EU
Japan
Biosimilars Sales by Region
LIEN HYPERTEXTE

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Main Actors
Source: IMS and EGA
 4 Categories of Players
 Top 3 Innovator Companies affected by Biosimilars

4 Categories of Players
LIEN HYPERTEXTE

Source: IMS and EGA
Amgen
AbbVie
Roche
Top 3 innovator companies affected by Biosimilars
Innovator companies affected by Biosimilars
LIEN HYPERTEXTE

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Evolution of Biosimilar and Originator manufacturing cost
-8%
-10%
-15%
-16%
-13%
-10%
-7%
-4%
-1%
Y 0 Y 2 Y 5
-25% -30%
-50%
-55%
-35%
-15%
Y 0 Y 2 Y 5
0
Evolution of retail price for Originators
Evolution of hospital price for Biosimilars
 Before the arrival of a Biosimilar on the market, we observe a price cut of 10% and 15%
 Example: APHP bought Inflectra after the company offered a discount of 45 percent
Our interviewees vision on the evolution of price
Source: APHP, Reuters
Outside the Scope

Source: Bloomberg & IMS
Outside the Scope
Remicade
Biosimilars
Countries Companies
Name of the
drug
Discount
Market Share in
2015
Norway Orion Pharma Remsima 72% 70%
Poland
Hospira
Orion Pharma
Inflectra
Remsima
51% - 69% 67%*
*Market share of Inflectra and Remsima in Poland
What strategies for these companies?
 Cost Strategy
• Looking for Experience Effect (loi de Wright)
• Looking for more Market Share
 User Experience Strategy
• Identify the Value Creation of the drug
• Have more Clinical Data on the drug
 Open the doors to Interchangeability and Subtitution
LIEN HYPERTEXTE

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Leadership Position of Originators
The interviewees think that the market share of Originators will depend on 4
factors:
4
Factors
Regulation
Trust
Cost
Adaptability
Source: Interview

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Choosing between biosimilars of the same reference product
The interviewees think that 3 factors influence the choice of a biosimilar:
3
Factors
Clinical trial
data
Price
Manufacturer
site
Source: Interview
1
3 2

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Biosimilars and Generics: Nature, Regulation and Market
trends
Comparison between Biosimilars and Generics in terms of Nature, Regulation and Market
trend, the position of the interviewees:
 Not comparable: The biosimilars differ in the complexity of the manufacturing process,
large complex molecules and the inherent variability in the biological systems used
 Comparable: The common point between biosimilars and generics is only the drop in
drug prices and loss of patents
Source: Interview
20%
40%
100% 100%
80%
60%
0
0,2
0,4
0,6
0,8
1
Authorities Patient
Associations
Comparable
Not comparable

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STRATEGIC POSITIONING
FOR ORIGINATORS

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Sample of the Benchmarking
Benchmarking
 13 companies
 From 2000 to 2015
 Identify the strategic positioning of Originator manufacturers
Face Biosimilars competition
Company Product
Glaxosmithkline Augmentin, Paxil, Amoxicilline
Lilly Prozac
Sanofi Cardizem
Servier Périndopril
Merck & Co Claritin
Fournier Lipanthyl
Astrazeneca Oméprazole Astrazeneca
Merck-Lipha Glucophage
MSD Inegy , Zocor
Pfizer Gabapentine pfizer
Amgen Neupogen
Bristoll Myers Squibb Buspar
Teva Simvastatine Teva

Price
Patent
Legal Action
Cooperation
Product
Prescription
Market
Saturation
New Market
Environmental
Strategy
Brand
Strategy
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The 10 levers of Originators to face Biosimilars
10 Levers
1
4
3
2
8
7
6
5
10
9

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Focus on Environmental Strategy
Environmental Strategy
3 Actions:
 Promote the obligation of the four-letter code (BQ) at the end of the
name of Biosimilars
 Promote for the Biosimilar a different Summary of Product Characteristics
(SmPC) from the Generics and Originators
 Promote the substitution of Biosimilars by physicians
All this will contribute to highlight that biosimilars unlike generics are not
identical to originators, but different products
9
BQ: Biological Qualifier
Source: Interview

Brand Strategy
2 Actions:
 Create more adhesion of patients and healthcare professionals to
their drugs (adhesion to the brand)
 Bring more services to patients and healthcare professionals on their
drugs (For example monitoring)
 Example: Amgen’s Evaluation of personalized patient counseling for
Enbrel
 Phase IV trial with 300 patients with RA
 Patient adherence and persistence to therapy in chronic disease
 Justify a premium price for Enbrel over Biosimilars
10
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Focus on Brand Strategy
Source: InterviewRA: Rheumatoid Arthritis

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Key Learning
Source: Interview
 No Single but Combination of Strategy
 No Global but Glocal Strategy
 Example: Neupogen, Amgen

Source: Interview
Localization
Neupogen
Amgen
Global USA Mature Market Emerging Market
Patent Legal Action
• Cooperation
• New Product
• Market Saturation
New Market
Combination and Glocal Strategy
4 Locations for 6 Strategies
LIEN HYPERTEXTE

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CONCLUSION

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Conclusion
 Reduction of health spending in OECD countries
 Clear difference between Biosimilars and Generics
 EU: the most advanced market for Biosimilars
 Substitution and interchangeability are great issues for all actors
 Germany: the most favorable regulation for Biosimilars
 Regulation issues on Biosimilars evolve quickly
 10 levers of Originators to face Biosimilars

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Information about the author
I am fascinated by healthcare and the experience of many
companies to develop new types of drug with the aim of saving
lives around the world.
Main topics of passion in the healthcare:
- Strategy
- Digital
- Innovation
- Biosimilars
If you want to know more, please contact me:
joseph.pategou@skema.edu
M. Joseph Pategou

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THANK YOU FOR YOUR
ATTENTION

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APPENDIX

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THE 10 LEVERS: Comparison of levers used to face Biosimilars
and Generics
Levers Biosimilars Generics
Price X X
Patent X X
Legal Action X X
Cooperation X X
Product X X
Prescription - X
Market Saturation - X
New Market X -
 Common points between strategy to face the Biosimilars and Generics
competition

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Price
1
866,08 € 858,47 € 858,47 €
749,01 € 746,17 €
691,91 € 688,28 € 703,74 € 700,89 €
0
300
600
900
2006 2008 2009 2012 2015
Price(euro)
NEUPOGEN 48 MU (0,96 MG/ML)
TEVAGRASTIM 48 MUI/0,8 ML
Graph 23: The evolution of Neupogen and Tevagrastim price over 2006-2015

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Cooperation
4
The company’s CEO Kevin Sharer stated in January 2011 that in order to drive
growth, the company was going to consider entering the biosimilars sector but “in a
controlled way,” (Beasley, 2011).
In December 2011, Amgen announced it had signed a deal with Watson to develop
and commercialize a number of oncology biosimilar monoclonal antibodies (MAbs).
Under the agreement, Amgen will be primarily responsible for developing, manufacturing
and initially commercializing the products, while Watson will put in up to $400m in co-
development costs and will share product development risks. Biosimilars from the
collaboration are expected to be sold jointly by both companies.
Amgen has secured a clause which prevents the collaboration from making biosimilar
versions of its drugs including Enbrel (etancercept), Aranesp (darbepoetin alfa) and
Epogen (epoetin alfa).
This deal gives the opportunity to Amgen to enter the biosimilars arena, to develop his
know how and to know more how his can protect his product, Neupogen.

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Prescription
6 Prescription
The new European regulations promote this strategy by granting one year
additional exclusivity for products that laboratories decided to switch to OTC.
Pharmaceutical laboratory make the drug available without a prescription and
bet on attachment to the brand.
The Claritin (loratadine ) medicine of the laboratory MSD became OTC in the
United States in November, 2002. Generic version entered on the market in the
end of December, 2002.

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The evolution of sell of Neupogen from 2008 to 2014
1,4
1,2
0
0,4
0,8
1,2
2008 2014
Billion$
Sales of Neupogen

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GLOBAL ECONOMIC SITUATION: Reduction of health spending

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Anti-TNF, Insulins and Onco MABs are the key biologics
Source: IMS

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NAMING

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COMPARISON OF DIFFERENCE AND COMMON POINTS BETWEEN
BIOSIMILARS AND GENERICS-STRUCTURE
KEY POINTS BIOSIMILARS Generics
Nature
Drug extracted from a biological
environment
Chemical drug
Molecular size Up to 270,000 Da 100 to 200 Da
Development Comparative studies Bioequivalence studies
Duration of development 5-7 years(500 patients) 2-3 years (20-50 patients)
Cost of the development 200-300 million dollars 2-4 million dollars

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TOP DRUG-PATENT EXPIRE

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MARKET TRENDS: Global picture
KEY POINTS DIFFERENCE IDENTICAL
The leading countries x
Market value x
Number of product x
Production cost x
Comparison between Biosimilars and Generics
Focus on EU :
 Most advanced market
 80% of global spending in 2011
 11% of total biologics sales in 2011
 50% of the off-patent biological market in 2020
Countries Sales in volume
(M)
Sales in value
( M€)
Germany 6,1 68
France 2,7 40
Italy 2,5 22
UK 0,5 19
Biosimilars market in volume and value in 2011
Source: IMS

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THE FUTURE BIOSIMILARS

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BIOSIMILARS MARKET IN VOLUME AND VALUE

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STRATEGIES OF PHARMACEUTICAL COMPANY TO PROTECT THE
PLACE OF THEIR MEDICINE-(GENERICS)
DCI Laboratory
Name
Patent Legal
Actions
Product Brand
Strategy
Amoxicilline-
acide
clavulanique
Glaxo
Smith-Kline X X X
Buspirone Bristoll Myers
Squibb
X X
Gabapentine Pfizer X X X
Omeprazole Astra
Zeneca
X X X

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MANUFACTURING OF BIOSIMILARS
Un processus de fabrication en 6 étapes:
Les biosimilaires sont composés de protéines recombinantes dont la fabrication
se décline en 6 étapes. Chacune de ces étapes implique d’importants efforts en
R&D et en contrôle qualité : les propriétés thérapeutiques des molécules
dépendent fortement de leur processus de fabrication.
1. Sélection du gène et de la cellule-hôte
2. Création d’une culture cellulaire à partir d’une banque de cellules
3. Synthèse de la protéine recombinante par les cellules hôtes
4. Purification de la protéine synthétisée
5. Formulation du médicament
6. Conditionnement pharmaceutique

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REFERENCE
1. http://www.sante.gouv.fr/qu-est-ce-qu-un-generique.html
2. Where the opportunities are and what role will they play? EGA Lisbon 2011-IMS
3. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000318.jsp
4. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
6. Shaping the biosimilars opportunity-december 2011
7. http://www.sante.gouv.fr/qu-est-ce-qu-un-generique.html
8. Rapport 2012 sur les médicaments génériques-Mutualité Française
9. EMA Procedural advice for users of the centralized procedure for generic/hybrid applications
10. Lessons learned from the review of the labelling of 5 centrally authorised pandemic vaccines- 10 February 2014 EMA
11. Rapport 2012 sur les médicaments génériques- Mutualité Française
12. http://gabionline.net/Biosimilars/General/Germany-wants-to-increase-biosimilars-penetration
13. http://ec.europa.eu/health/authorisation-procedures_en.htm
14. Guideline on the investigation of bioequivalence- London, 20 January 2010- European Medicines Agency
15. http://www.australianprescriber.com/magazine/26/4/article/712.pdf
16. Directive 2001/83/EC, as amended by Directive 2003/63/EC and Directive 2004/27/EC
17. Biosimilars Marketing Authorisation status as of January 2013: 22 Marketing Authorisation Applications
18. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000318.jsp
19. Individual case safety report: Article 28 of Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012
20. Biological Qualifier An INN Proposal-July 2014- World Health Organization, Geneva
21. http://www.gabionline.net/Biosimilars/Research/Improved-labelling-sought-for-biosimilar-acceptance
22. EC consensus paper 2013- What you need to know about Biosimilar Medicines
23. European Commission consensus paper 2013 : What you need to know about biosimilar medicines
24. http://gabionline.net/Biosimilars/General/Germany-wants-to-increase-biosimilars-penetration
25. http://gabionline.net/Biosimilars/Research/Extrapolation-for-biosimilars
26. Directive 2001/83/CE du parlement européen et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux
médicaments à usage humain
27. Where the opportunities are and what role will they play? EGA Lisbon 2011-IMS
28. http://healthcare.blogs.ihs.com/2012/01/06/generic-drug-price-trends-france-germany-italy-spain-uk/

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REFERENCE

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REFERENCE

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QUESTIONS FOR THE INTERVIEWS
1. Generally, a comparison is made between Biosimilars and Generics in terms of regulation, market
penetration and sales. According to you, what are the aspects of Biosimilars comparable to Generics, and
which ones are not?
2. In Europe, Germany is the largest market for Biosimilars. According to some, this advance may be
explained partly by price regulation and Biosimilars repayment terms in Germany. In your opinion, what is
the role of regulation in the European market for Biosimilars?
3. The name of a medication is an important element. It allows their differentiation and reassure
patients. Regarding Biosimilars, the World Health Organisation has chosen to develop a four-letter code at
the end of the name (for instance: epoetin alfa bbbb). This code is entitled to differentiate Generic and
Originators from Biosimilar. What do you think of this approach?
3.1 Some professionals believe that this differentiation will hamper the substitution needed to reduce
health care costs. What is your opinion?
3.2 Will this naming system allow to more easily track the adverse effects that could be included in the
patient records?
3.3 Do you think of other advantages or disadvantages related to this approach?
4. Instructions accompanying medication provides important information for its proper use and for
patient safety. Do you think the instructions of a Biosimilar should provide the same information as the ones
of the Generic or Originators it replaces?
4.1 In order to strengthen trust, some associations recommend a combination of information about
each Biosimilar and the reference product in the record. What is your opinion regarding this proposal?
4.2 Will not a different instruction between the Biosimilar and reference lead the prescriber to the
conclusion that Biosimilars do not require the same level of proof that their reference products?
4.3 Do you see other advantages or disadvantages in the fact of differentiating instruction of a Biosimilar
from the one of its reference product?

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5. Some reference products already commercialised are used in several therapeutic indications.
Regarding Biosimilars, is such a use desirable?
5.1 If extrapolation is desirable, is conducting a clinical study necessary?
5.2 If not, is it necessary to implement the same approach, which is used for Generics? (Meaning setting
up bioequivalence studies?)
6. In France, Italy, and in Germany, the replacement of a medication by a Generic is possible through a
pharmacist. Do you think that this process should be extended to Biosimilars?
6.1 In your opinion, is replacement by Biosimilar not going to threaten medication’s traceability, and thus
the identification of the origin of undesirable reactions in the patient?
6.2 The process of substitution requires the creation of a regulatory basis for interchangeability criteria. Do
the expected benefits of such regulations allow you to justify the costs and regulatory risks borne by the
stakeholders (government and companies)?
7. In Germany, in some cities such as Bremen, a quota system encouraging doctors and health insurance
fund to use Biosimilars has been set up. It is translated into an increase in the prescription of Biosimilars in this
town. What is your point of view regarding the set-up of quotas or call for tender for Biosimilars?
7.1 As part of a call for tender, if a company wins a two-year contract, there is little incentive for
competitors to produce. If the provider chooses not to meet its obligations, there is a risk of supply disruption.
Do you think that it is a major issue in your country? What would you consider the best way to prevent this
situation?
7.2 In order to improve the penetration of Biosimilar in various countries, would not it be more effective to
communicate to physicians and suppliers about the high quality standards for Biosimilars? What would be
according to you the best way to answer it?

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8. In 2013, on the world scene the Biosimilars market accounted for $ 1.3 billion of which 80% in
Europe. By 2020 it will account for $ 25 billion. According to you, what will be the evolution of this
market in the upcoming years in Europe, especially in France, Germany, Italy and in the United
Kingdom?
9. The introduction of Generics has significantly reduced medication prices. For instance, in Germany
the decrease can reach of 71%. Regarding Biosimilars, may we expect such a decrease?
10. With Biosimilars and Generics being present on the market, do you think that Originators
medications will keep their leadership in France, Germany, Italy and in the United Kingdom?

BIOSIMILARS - Regulation and Market Trends

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