Biosimilars and Generics: A Comparison

1
Biosimilars and Generics
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A comparison
Joseph Pategou
International Strategy and Influence
joseph.pategou@skema.edu

23/05/2016 GENERICS AND BIOSIMILARS – Joseph Pategou 2
SUMMARY
Introduction
I. Regulation: GENERICS AND BIOSIMILARS
II. Market Trends: GENERICS AND BIOSIMILARS
Conclusion
Information about the Author
Appendix

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introduction
GENERICS AND BIOSIMILARS – Joseph Pategou

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generics

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Generics: Definition and Life cycle
Source: http://www.sante.gouv.fr/qu-est-ce-qu-un-generique.html
A generic medicine contains the same active ingredient as the
originators product on which it is based and as such is interchangeable
with this originators. It offers the same high quality and efficacy,
together with affordability. In theory, dosage, indications, cons-
indications, side effects and safety guarantees are the same.
This combination has made them increasingly attractive for
healthcare systems as a whole and patients in particular. They can be
marketed after the patent expiry of the originators product on which they
are based.

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Generics: Definition and Life cycle

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BIOSIMILARS

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Biosimilars: Definition and Life cycle
Source: Directive 2001/83/EC, as amended by Directive 2003/63/EC and Directive 2004/27/EC
Biosimilars Marketing Authorisation status as of January 2013: 22 Marketing Authorisation Applications
http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000318.jsp
The concept of a “similar biological medicinal product” was adopted in EU
pharmaceutical legislation in 2004 and came into effect in 2005. The first biosimilar
medicine was approved by the European Commission in 2006.
A biosimilar medicinal product is a biological medicine which is similar to another
biological medicine that has already been authorized for use, the “reference medicinal
product”.
The EU is the first region in the world to have set up a legal framework and a
regulatory pathway for “similar biological medicinal products”, more commonly called
“biosimilars”. The EU regulatory framework inspired many countries around the world
e.g. Australia, Canada, Japan, Turkey, Singapore, South Africa, Taiwan, USA etc. as
well as the World Health Organization (WHO).

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Biosimilars: Definition and Life cycle

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REGULATION

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Generics

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Naming
Source: EMA Procedural advice for users of the centralized procedure for generic/hybrid applications
The naming of a drug is important; it allows their differentiation and gives confidence to
patients.
The use of a single name is also a requirement for generic/hybrid medicinal products
regardless of whether the applicant/ Marketing Authorization Holder (MAH) wishes to use an
invented name or a common name or scientific name, together with a trademark or the name of
the MAH.
It should be noted that the applicant/MAH will be required to identify the ‘reference
medicinal product’ and the legal basis for submission of the application within the invented name
notification.
The name review group should also be consulted where the applicant/MAH (Marketing
Authorisation Holder) wishes to use the common or scientific name, together with a trademark or
the name of the Marketing Authorisation Holder.
The requirement for a single name for a generic medicinal product of a reference medicinal
product authorized through the Centralized Procedure applies also in the case the generic
medicinal product is authorized by member states via the Mutual Recognition or Decentralized
Procedure

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Labelling
Source: Lessons learned from the review of the labelling of 5 centrally authorised pandemic vaccines- 10 February 2014 EMA
The label of a drug provides important information for the proper use and patient
safety. We can regroup all this information in 5 groups:
1. Definition of the drug
2. Information you must know before taking the drug
3. How to take the drug?
4. What are the possible side effects?
5. How to store it?
The name of those groups can be different in some countries. Consistency and
transparency of labels lead to a better understanding and acceptance of the drug with
all stakeholders (Patients, Professionals….).
In the case of the generic, the label of the drug is an identical copy of the reference
product.

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Substitution
Source: Rapport 2012 sur les médicaments génériques- Mutualité Française
The substitution by the pharmacist is allowed in France, in Italy and in
Germany but is forbidden in United Kingdom.
France and Italy have a system of price setting, in Germany we don’t
have this king of system and in United Kingdom also but generic can’t be
more expensive than reference drug.
In some of those countries, we have incentive plan in the delivery of
generic medicines by the pharmacists for example in France (see Table 2).

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Substitution
Source: Observatoire du médicament FNMF à partir des données de l’EGA et de l’AIM, 2011 et 2012
United Kingdom France Italy Germany
System of Price setting Free. But generic
can’t be more
expensive than the
reference drug.
The prices of
refundable
medicine are
administered
Yes Free
Is there a right of
substitution by the
pharmacist?
No, But the
prescriptions are
most of the time
Denominated in
DCI (INN)
Yes, in the
perimeter of the
directory of the
generic groups.
Yes. The
substitution is
legally
authorized. The
doctor can
oppose to the
substitution
Yes. The substitution
is compulsory except
opposite mention of
the doctor
Is there a plan of
incentive in the delivery
of generic medicines by
the pharmacists?
No Yes. Preferential
margin and
payment in the
performance.
No No. The amount of
the remuneration is
fixed by prescription
DCI: INN: International non-proprietary name
Table 2: Comparison between countries in term of price and substitution

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Quotas and Tenders
Source: http://gabionline.net/Biosimilars/General/Germany-wants-to-increase-biosimilars-penetration
In France, in United Kingdom, in Germany and in Italy, we don’t have a
system of quotas for drug.
We have tenders in Germany; this concerns only the new type of drugs and
many actors are involved in the mechanism of calls for tender for example: the
Health Insurance Funds. In France, we also have tenders for the hospital market.
We observed discussion concerning the implementation of a system of calls for
tender in the United Kingdom and Italy.

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Quotas and Tenders
Source: Observatoire du médicament, FNMF à partir des données EGA 2011, AIM 2012, ESIP 2012
United Kingdom France Italy Germany
Existence of an (ambulatory)
mechanism of calls for tender
No Yes, in hospital No Yes, all over the country and only
for new drugs
If yes, on what criteria are
negotiated the prices?
By active substance
by product,
by therapeutic indication
If yes, which actors are involved in
the mechanism of calls for tender
Health insurance funds and
industrialists of the medicine
Discussions concerning the
implementation of a system of
calls for tender
Yes, at the government
level
Yes, at the level of the
compulsory health
insurance and of the
parliament
Yes, at the local health
authorities (21
regions)
Yes, in government and health
insurance funds
Table 3: Comparison between countries in term of tenders

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Marketing Authorization/Clinical trials
Source: http://ec.europa.eu/health/authorisation-procedures_en.htm
Any drug, to be marketed, must obtain a Marketing Authorization. For this, the
applicant must file an application with the competent health authorities, that is to say, the
National Security Agency for Drugs and Health Products, as part of a national procedure or
the European Medicines Agency (EMA), as part of a European procedure.
The format of the Marketing Authorization application is standardized internationally
(Europe, USA and Japan), which is why it is called "Common Technical Document"
(CTD).
It includes five modules:
Module 1: Administrative Information
Module 2: Summary of module 3, 4 and 5
Module 3: Chemical and pharmaceutical data on the quality of the active substance and the
finished product (Physico-chemical data of the active substance, control, packing and
stability of the active substance and the finished product)
Module 4: Safety data (toxicological data on the basis of non-clinical reports)
Module 5: Data on the efficacy of the drug from the results of clinical studies on humans

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Source: Guideline on the investigation of bioequivalence- London, 20 January 2010- European Medicines Agency
http://www.australianprescriber.com/magazine/26/4/article/712.pdf
So, generic medicines, in support to their file of demand for marketing authorization,
are dispense of producing the results of clinical study demonstrating the efficiency of the
active ingredient, but they have to demonstrate their bioequivalence in regards to the
reference medicine.
For Professor Donald J. Birkett, “two pharmaceutical products are bioequivalent if they
are pharmaceutically equivalent and their bioavailabilities (rate and extent of availability)
after administration in the same molar dose are similar to such a degree that their effects,
with respect to both efficacy and safety, can be expected to be essentially the same.
Pharmaceutical equivalence implies the same amount of the same active substance(s), in the
same dosage form, for the same route of administration and meeting the same or comparable
standards.”

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Source: Guideline on the investigation of bioequivalence- London, 20 January 2010- European Medicines Agency
http://www.australianprescriber.com/magazine/26/4/article/712.pdf
Comparison of the contents of the file of the demand of marketing authorization
File of the demand of marketing
authorization
Originators Generics
Module 1
Administrative Information
Yes Yes
Module 2
Summary of Module 3, 4 and 5
Yes Yes
Module 3
Quality (manufacturing process)
Yes Yes
Module 4
Safety (non-clinical studies)
Yes Not required
Module 5
Efficacy (clinical studies )
Yes Bioequivalence Study
Table 4: Comparison of the marketing authorization between generics and
originators

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BiOSIMILARS

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Naming
Source: Individual case safety report: Article 28 of Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012
Biological Qualifier An INN Proposal-July 2014- World Health Organization, Geneva
As required by EU law, every medicine will either have an invented (trade) name, or the
name of the active substance together with the company name/trademark. The World Health
Organization (WHO) suggests that the current system for choosing INNs remain intact, but that a
four-letter code would be attached at the end of every drug name. The WHO says the approach,
which would apply retroactively, would be voluntary.
The code will consist of four letters and each code issued will be assigned randomly. The
choice of letters used will be made to facilitate transliteration into various languages and to avoid
meaningful or inappropriate words being used. The use of four letters offers more than 160 000
codes (204). This is expected to provide sufficient flexibility for the foreseeable future. (Biological
Qualifier code = BQ code)

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Labelling
Source: http://www.gabionline.net/Biosimilars/Research/Improved-labelling-sought-for-biosimilar-
acceptance
The European Medicines Agency approaches on biosimilar labelling
requiring the label of the biosimilar product, which describes its medical use. It
isto be consistent with the label of the reference product.

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
Country Substitution
United Kingdom Not authorized
France Decree Pending
Italy Not authorized
Germany Possible between Biosimilars
Position of each country on Substitution
Source: See appendix

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Interchangeability
 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)
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Extrapolation
Source: EMA

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
Source: EMA

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MARKET TRENDS

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GENERICS

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Globally, there are eight major world markets: The United States, Germany,
France, United Kingdom, Canada, Italy, Spain and Japan. They represent 84% of
global sales.
The United States is the largest generics market in the world with 42% of global
sales.
In those countries, the generic drug plays a major role in controlling health
spending, balance and survival of social protection models.
In developing countries, this helps people to have access to healthcare because
the price of the generics drugs is less expensive.
The European market for generics varies from a country to another, this is due to:
 The maturity of the market
 The generic definition
 The incitement mechanism
 The organization
Global Picture
Source:Where the opportunities are and what role will they play? EGA Lisbon 2011-IMS
http://healthcare.blogs.ihs.com/2012/01/06/generic-drug-price-trends-france-germany-italy-spain-uk/

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Global Picture
Source:Where the opportunities are and what role will they play? EGA Lisbon 2011-IMS
http://healthcare.blogs.ihs.com/2012/01/06/generic-drug-price-trends-france-germany-italy-spain-uk/
A Global analysis finds that the market earned revenues is $123.85 billion in 2010
and will reach $231.00 billion in 2017 at a compound annual growth rate of 9.29 per
cent from 2011-2018. (The United States, Europe (Germany, the United Kingdom,
France, Spain, and Italy) and Asia (India and China)).
N° Company N° Company
1 CRISTERS 10 SANDOZ
2 ZENTIVA 11 MEDIS
3 VENIPAHRM 12 EG LABO
4 SUBSTIPHARM 13 HOSPIRA
5 ARROW 14 H2PHARMA
6 ZYDUS 15 DELPHARM
8 RANBAXY 16 BIOGARAN
9 TEVA LABORATOIRES
Table 10: Example of Generics companies in Europe

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Global Picture
Source: IMS Health
Graph 3: The Generic market share in Europe
Country Ranking
United Kingdom 1st
Germany 2nd
France 3rd
Italy 4th
Table 8: Ranking of generics market

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Global Picture: United Kingdom
Source: http://www.britishgenerics.co.uk/about-generics/the-generics-industry
The generics market in the United Kingdom is the first largest generic market, after the United
States. It is the most mature market with over 60% market share by volume for generics.
The United Kingdom has a competitive, multi-source generic market which keeps medicine
prices at the lowest level in Europe. Generic competition - that occurs when a branded product loses
its patent protection – reduces prices by 90%.
The onset of generic competition also drives innovation because the originators know that their
products will eventually face generic competition leading to a significant fall in sales and income, they
need to research new medicines.
Each year nearly three quarters of prescriptions in England and Wales are met by generic
products, saving the NHS (National Health Service) more than £11billion.
The British Generic Manufacturers Association (BGMA) represents the interests of UK-based
manufacturers, suppliers of generic and biosimilar medicines. BGMA promotes the development,
understanding of the generic and biosimilars medicines industry in the United Kingdom.

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Global Picture: Germany
Source: http://translate.google.fr/translate?hl=fr&sl=de&u=http://www.progenerika.de/&prev=search
The German generic market is the second largest market in the world,
with over 60% market share by volume for generics. The prices of generic
drugs are on average 71% lower than those of their originators.
In Germany, generics companies cover almost 75 percent of the total
drug needs for the care of patients. For 100 patients treated with medication,
75 patients used generic products. Progenerika is the association for generics
and biosimilars producers in Germany.

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Global Picture: France
France is considered as a market that has not optimized its generic
development potential, which exceeds 40% market share in volume, but still
below the world average.
In 2013, the savings from generics represent more than € 2.4 billion. Since
2000, cumulative savings are more than € 15.5 billion. This is due to the price
of the generics which are 75% to 80% lower than the Originators. According to
the GEMME growth of 4% is expected for 2014. GEMME is the association
for generics drugs, but it is also the Association of biosimilars drugs.

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Global Picture: France
Generics in France
Year Number of pack of drug
2002 1 pack medicine on 20
The generics market prescribed and refundable
Year
Number of pack
(Million packs)
2012 675
2013 785
Table 9: Evolution of pack of drugs from 2002 to 2013

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Global Picture: Italy
Italy is considered less active from the point of view of generic
penetration with over 30% market share by volume for generics. The prices
of generic drugs are on average 56% lower than those of their originators
Assogenerici (National Association of Industries Drugs Generic) is the
official representative body of the industry of generics and biosimilars in
Italy, at the forefront in providing medicines at affordable prices and high
quality to millions of citizens. Also helps to stimulate competition and
innovation in the pharmaceutical sector.

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BiOSIMILARS

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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 CommissionSource: 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
40
Anti-TNF, Insulins and Onco MABs are the key biologics
LIEN HYPERTEXTE

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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

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4 Categories of Players
LIEN HYPERTEXTE

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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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Conclusion
Even if, the biosimilars and the generics came in the market after the end of originators patent,
the comparison between them clearly shows that these two types of drugs are different in terms of
regulation and market trends.
Biosimilar medicines are biologicals developed to be similar to an existing biological medicine.
Whereas generics have simple chemical structures and are considered to be identical to their reference
medicines.
On the regulation part, we see big difference.The marketing Authorization of generics is mainly
based on bioequivalence studies unlike biosimilars based on comparative study. Moreover, the
regulation of biosimilars is still not clear and still in discussion in many countries, unlike to generics
drugs.
In term of sales, generics are driven by eight major world markets accounting for 84% of global
sales (United States, Germany, France, Britain, Canada, Italy, Spain and Japan).
The United States is the largest generics market with 42% of global sales (global sales $123.85 billion
in 2010 and will reach $231.00 billion in 2017.
The most advanced market for biosimilars, is the EU representing 80% of global spending
(Global market: $2.6 billion in 2016 to $25 billion in 2020) with 19 biosimilars already marketed and
representing 6 actives substances. Germany is the first largest market in volume and value; followed
by France, Italy and United Kingdom.

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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

23/05/2016 Regulatory issues on the development of Biosimilars – Joseph Pategou 49
GLOBAL ECONOMIC SITUATION: Reduction of health spending

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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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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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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

Biosimilars and Generics: A Comparison

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