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1
BIOSIMILARS --------------------
Regulation, Market Trends AND
Originators strategyJoseph PategouInternational Strategy and [email protected]
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
23/05/2016 3
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
23/05/2016 4
INTRODUCTION
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 5
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)
Regulatory issues on the development of Biosimilars – Joseph Pategou
Source: Directive 2001/83/EC, as amended by Directive 2003/63/EC and Directive 2004/27/EC
Which regulatory framework for Biosimilars in Europe?
23/05/2016 6
Research Question
Regulatory issues on the development of Biosimilars – Joseph Pategou
What strategic positioning for the Originator manufacturers?
23/05/2016 7
METHODOLOGY
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 8
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
Regulatory issues on the development of Biosimilars – Joseph Pategou
Sample of the interviews
23/05/2016 9
Source: Interview Bx: Biosimilars Unions
Regulatory issues on the development of Biosimilars – Joseph Pategou
Sample of the Interviews
Types of Organizations Numbers
Unions 6 (Bx: 4)
Learned Societies 7
Patient Associations 3
Authorities 4
Others 2
LIEN HYPERTEXTE
23/05/2016 10
GLOBAL ECONOMIC SITUATION
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 11
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%
Regulatory issues on the development of Biosimilars – Joseph Pategou
Source: OECD
23/05/2016 12
REGULATION
Regulatory issues on the development of Biosimilars – Joseph Pategou
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
23/05/2016 13
Naming
DECISION MAKER
WHO
BQ: Biological Qualifier
Regulatory issues on the development of Biosimilars – Joseph Pategou
Source: WHO
100% 100%
50%50%
100%
0%
20%
40%
60%
80%
100%
Authorities PatientAssociations
Learned Societies Unions
Right approach
Wrong approach
23/05/2016 14
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
Difference of position:
Identical SmPC: No clinical differences between the Biosimilar and Originator
Different SmPC : Will be of help and allow comparison
DECISION MAKER
EMA
Regulatory issues on the development of Biosimilars – Joseph Pategou
Source: EMA
100%
33% 20%
80%67%
80%
20%0%
20%
40%
60%
80%
100%
Authorities PatientAssociations
Learned Societies Unions
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
23/05/2016 15
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
Difference of position:
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
Regulatory issues on the development of Biosimilars – Joseph Pategou
Source: See appendix
23/05/2016 16
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)
Regulatory issues on the development of Biosimilars – Joseph Pategou
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)
Difference of position:
Extrapolation: Biosimilars comparability has been demonstrated in one indication
No extrapolation: Biosimilars are not identical to the Originators
23/05/2016 17
ExtrapolationDECISION MAKER
EMA
Position of the interviewees on Extrapolation
Regulatory issues on the development of Biosimilars – Joseph Pategou
Source: EMA
100%
65% 60%
100%
35%20%
0%
20%
40%
60%
80%
100%
Authorities PatientAssociations
Learned Societies Unions
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
23/05/2016 18
Marketing Authorization
File of the demand of MA Originators Generics Biosimilars
Module 1Administrative Information
Yes Yes Yes
Module 2Summary of Module 3, 4
and 5Yes Yes Yes
Module 3Quality (manufacturing
process)Yes Yes Comparative studies
Module 4Safety (non-clinical studies)
Yes Not required Comparative studies
Module 5Efficacy (clinical studies )
Yes Bioequivalence Study Comparative studies
DECISION MAKER
EMA
Regulatory issues on the development of Biosimilars – Joseph Pategou
Source: EMA
23/05/2016 19
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
Regulatory issues on the development of Biosimilars – Joseph Pategou
Germany 6 KEY TOPICS
United
Kingdom6 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
23/05/2016 20
MARKET TRENDS
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 21
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
Regulatory issues on the development of Biosimilars – Joseph Pategou
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
23/05/2016 22
Source: IMS
Regulatory issues on the development of Biosimilars – Joseph Pategou
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
23/05/2016 24
Main Actors
Regulatory issues on the development of Biosimilars – Joseph Pategou
Source: IMS and EGA
4 Categories of Players
Top 3 Innovator Companies affected by Biosimilars
23/05/2016 25Regulatory issues on the development of Biosimilars – Joseph Pategou
4 Categories of Players
LIEN HYPERTEXTE
23/05/2016 26Regulatory issues on the development of Biosimilars – Joseph Pategou
Source: IMS and EGA
Amgen
AbbVie
Roche
Top 3 innovator companies affected by Biosimilars
Innovator companies affected by Biosimilars
LIEN HYPERTEXTE
23/05/2016 27
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
Regulatory issues on the development of Biosimilars – Joseph Pategou
Source: APHP, Reuters
Outside the Scope
23/05/2016 28Regulatory issues on the development of Biosimilars – Joseph Pategou
Source: Bloomberg & IMS
Outside the Scope
RemicadeBiosimilars
Countries CompaniesName of the
drugDiscount
Market Share in 2015
Norway Orion Pharma Remsima 72% 70%
PolandHospira
Orion Pharma
Inflectra
Remsima51% - 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
23/05/2016 29
Leadership Position of Originators
The interviewees think that the market share of Originators will depend on 4 factors:
4 Factors
Regulation
Trust
Cost
Adaptability
Regulatory issues on the development of Biosimilars – Joseph Pategou
Source: Interview
23/05/2016 30
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
PriceManufacturer
site
Regulatory issues on the development of Biosimilars – Joseph Pategou
Source: Interview
1
3 2
23/05/2016 31
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:
Difference of position:
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
Regulatory issues on the development of Biosimilars – Joseph Pategou
Source: Interview
20%40%
100% 100%80%
60%
0
0,2
0,4
0,6
0,8
1
Authorities PatientAssociations
Learned Societies Unions
Comparable
Not comparable
23/05/2016 32
STRATEGIC POSITIONING FOR ORIGINATORS
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 33
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
Regulatory issues on the development of Biosimilars – Joseph Pategou
Price
Patent
Legal Action
Cooperation
Product
Prescription
Market Saturation
New Market
EnvironmentalStrategy
Brand Strategy
23/05/2016 34
The 10 levers of Originators to face Biosimilars
10 Levers
1
4
3
2
8
7
6
5
10
9
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 35
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
Regulatory issues on the development of Biosimilars – Joseph Pategou
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
23/05/2016 36
Focus on Brand Strategy
Regulatory issues on the development of Biosimilars – Joseph Pategou
Source: InterviewRA: Rheumatoid Arthritis
23/05/2016 37
Key Learning
Regulatory issues on the development of Biosimilars – Joseph Pategou
Source: Interview
No Single but Combination of Strategy
No Global but Glocal Strategy
Example: Neupogen, Amgen
23/05/2016 38Regulatory issues on the development of Biosimilars – Joseph Pategou
Source: Interview
Localization
NeupogenAmgen
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
23/05/2016 39
CONCLUSION
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 40
Conclusion
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
23/05/2016 41
Information about the author
Regulatory issues on the development of Biosimilars – Joseph Pategou
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:
M. Joseph Pategou
23/05/2016 42
THANK YOU FOR YOUR ATTENTION
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 43
APPENDIX
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 44
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
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 45
Price
Regulatory issues on the development of Biosimilars – Joseph Pategou
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
Pric
e (
eu
ro)
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
23/05/2016 46
Cooperation
Regulatory issues on the development of Biosimilars – Joseph Pategou
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.
23/05/2016 47
Prescription
Regulatory issues on the development of Biosimilars – Joseph Pategou
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.
23/05/2016 48
The evolution of sell of Neupogen from 2008 to 2014
Regulatory issues on the development of Biosimilars – Joseph Pategou
1,41,2
0
0,4
0,8
1,2
2008 2014
Bill
ion
$
Sales of Neupogen
23/05/2016 49
GLOBAL ECONOMIC SITUATION: Reduction of health spending
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 50
Anti-TNF, Insulins and Onco MABs are the key biologics
Source: IMS
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 51
NAMING
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 52
COMPARISON OF DIFFERENCE AND COMMON POINTS BETWEEN
BIOSIMILARS AND GENERICS-STRUCTURE
KEY POINTS BIOSIMILARS Generics
NatureDrug extracted from a biological
environmentChemical 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
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 53
TOP DRUG-PATENT EXPIRE
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 54
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
Regulatory issues on the development of Biosimilars – Joseph Pategou
Source: IMS
23/05/2016 55
THE FUTURE BIOSIMILARS
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 56
BIOSIMILARS MARKET IN VOLUME AND VALUE
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 57
STRATEGIES OF PHARMACEUTICAL COMPANY TO PROTECT THE
PLACE OF THEIR MEDICINE-(GENERICS)
DCI LaboratoryName
Patent LegalActions
Product Brand Strategy
Amoxicilline-acide
clavulanique
GlaxoSmith-Kline X X X
Buspirone Bristoll MyersSquibb
X X
Gabapentine Pfizer X X XOmeprazole Astra
ZenecaX X X
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 58
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
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 59
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/
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 60
REFERENCE
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 61
REFERENCE
Regulatory issues on the development of Biosimilars – Joseph Pategou
23/05/2016 62
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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QUESTIONS FOR THE INTERVIEWS
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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QUESTIONS FOR THE INTERVIEWS
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?
Regulatory issues on the development of Biosimilars – Joseph Pategou