Provides an overview of the development of biotherapeutic & biosimilar regulations in Russia.

1. Development vector of regulatory
procedures of biological medicines
in Russia
Elena Maksimkina
Head of Department of state regulation of medicine, Ministry
of Health
Ph.D. (pharmacy)
Moscow 15.05.2013
BIOTHERAPEUTIC MEDICINES

2. Development of formal institutes in the
field of Health care in Russia
National project “Health”
Federal Law FZ-323 of 21.11.2011 “ On Fundamentals of
Healthcare Protection of Citizens in the Russian Federation”.
Federal Law FZ-61 of 12.04.2010 “On the Circulation of
Pharmaceuticals”
Strategy of the development of pharmaceutical industry until
2020
Concept of health care development until 2020
Programs of modernizing health care of the Russian
Federation

3. Main areas of regulation
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Modifications de la loi
fédérale « sur la
distribution des
médicaments »
Développement du cadre
conceptuel :
• médicaments biologiques
• médicaments bioanalogiques
• médicaments de référence
• médicaments génériques
Création des conditions pour un meilleur
contrôle officiel des prix des médicaments
Habilitation complémentaire du Ministère de la santé de Russie
• validation de la liste des noms de médicaments
• introduction d’un registre d’instructions concernant l’utilisation médicale
des médicaments
• validation de règles pour un choix rationnel des noms des médicaments à
usage médical
Définition des
particularités de l'examen
de certains groupes de
médicaments
Introduction de la notion de
« médicaments orphelins » et
de leur procédure
d’homologation
Harmonisation avec la législation
internationale :
• élaboration du dossier d’homologation
• introduction des normes de pratique
conforme clinique et pré-clinique

4. Need to Define the Regulation Object
62) Biological medicinal product is a medicinal product, the active substance of which is a
pharmaceutical substance obtained or extracted from a biological source, and determination of
properties and quality of which takes a combination of biological and physical/ chemical
methods. Biological medicinal products include immune biological medicinal products, medicinal
products derived from human and animal blood and plasma, biotechnological medicinal
products, gene therapy and somatic cell therapy medicinal products;
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The proposed wording takes into account the problems with the maximum assessment of this
group of medicinal products and includes the necessary groups of medicinal products and methods,
so that to avoid including herbal medicinal products, glucose, antibiotics into the group of biological
medicinal products and other possible collisions.
Classification of the variety of biological medicinal products by different classification attributes
(production technology, source of medicinal product) is a strong aspect of the proposed definition.

5. Need to Define the Regulation Object
71) Biotechnological medicinal product - a medicinal product that is manufactured through the
stages using biotechnological processes, including recombinant DNA technology, the technology
of controlled expression of genes coding biologically active proteins in procaryotes and
eucaryotes, including modified mammal cells, hybrydoma antibody and monoclonal antibody
technology;
72) Gene therapy medicinal product – a biological medicinal product, the pharmaceutical substance
of which represents or includes a recombinant nucleic acid that enables to regulate, repair,
replace, add or delete some genetic sequence;
73) Somatic cell therapy medicinal product – a biological medicinal product that represents or
includes cells or tissues with the biological features and physiological functions or structure
modified for the intended use, or that represents or includes cells or tissues not intended for
performance of the same basic functions in the recipient as in the donor
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6. Need to Define the Regulation Object
122) Biosimilar medicinal product (biosimilar) – a biological medicinal product that is similar to the
originator biological medicinal product in the same dosage form by quality, efficacy and safety;
121) Comparator (reference) medicinal product – a medicinal product registered based on own pre-
clinical and clinical trial data and used to assess quality, efficacy and safety of a generic
medicinal product, if there is no originator medicinal product corresponding to it in the State
Register of Medicinal Products;
123) Interchangeable medicinal product – a medicinal product, other than a biological medicinal
product, with proven therapeutic equivalence to the originator medicinal product or the
comparator medicinal product, which is used for the same indications (except for the
indications, which are protected in the Russian Federation by applicable patents), has the same
qualitative and quantitative composition of active substances as well as the same dosage form,
dosing rate and method of administration, and manufactured in accordance with the rules for
manufacturing of and quality control over medicinal products;
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7. Treatment Process Drivers
•State
•Physician
•Pharmacist
•Manufacturer –
(in particular, via the
institute of medical
representatives)

8. Reasons to Discuss Intercheangibility
1. Economic aspect
 Medicinal treatment cost increase:
 Savings on purchases
 Affordability
 Competition between originator and generic medicinal products
 Market share
 Identity in terms of:
 Efficacy and safety
 Quality
 Consumer properties (convenience of administration, action spectrum)
2. Therapeutic aspect
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9. Biological Medicinal Products Registered in
the Russian Federation
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Group Number of SKUs (in particular,
taking into account the
production site)
Foreign
Erythropoetins 20 8
Interferons 53 20
Monoclonal antibodies 42 37
Insulins 61 40
Somatropins 11 7
G-CSF 24 17
Heparins 55 25
Plasma coagulation factors 31 19
r-coagulation factors 9 3

10. FSBI «SCIENTIFIC CENTRE FOR EXPERT
EVALUATION OF MEDICINAL PRODUCTS»
OF THE MINISTRY OF HEALTH
The Scientific centre’s divisions on the map of
Moscow
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11. For purposes of implementing the new state policy
regarding the circulation of medicinal products
(Federal law № 61-FZ, dated 12 May, 2010)
The institution’s legal organizational form and structure were changed
New functions and tasks were determined
State certification of experts was carried out
Scientific and methodological support for evaluation of quality, efficacy
and safety of medicinal products is constantly being improved
FSBI «SCIENTIFIC CENTRE FOR EXPERT
EVALUATION OF MEDICINAL PRODUCTS»
OF THE MINISTRY OF HEALTH11
FSBI «SCIENTIFIC CENTRE FOR EXPERT
EVALUATION OF MEDICINAL PRODUCTS»
OF THE MINISTRY OF HEALTH

12. Organizational structure
SCIENTIFIC CENTRE FOR EXPERT
EVALUATION OF MEDICINAL PRODUCTS
ADMINISTRATIVE AND
MANAGERIAL DIVISIONS
Quality
assurance
department
SCIENTIFIC DIVISIONS
Centre for evaluation of
medicinal products safety
Centre of pharmacopoeia
and international
cooperation
Centre of clinical
pharmacology
Centre of educational
programs
Centre for planning and
coordination of research
and development activities
EXPERT DIVISIONS
CENTRE OF FPP
EXPERTISE
(5 boards)
TESTING CENTRE
FOR EVALUATION
OF MEDICINAL
PRODUCTS
QUALITY
(11 laboratories)
CENTRE OF MIBP
EXPERTISE
(3 boards)
TESTING CENTRE
FOR EVALUATION
OF MIBP QUALITY
(10 laboratories)
MIBP CERTIFICATION
CENTRE
Management and
organization
department
Reference information:
Staff numbers of the Institution – 900 employees
Members of the Russian Academy of Medical Sciences – 4
Professors – 19
Doctors of Science – 56
Candidates of Science – 214
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13. Main functions of the FSBI “SCEMP”
 assessment of applications for the registration of medicinal products in
Russia and post-authorization variations filling of already registered
medicinal products in respect of their quality, efficacy and safety;
 evaluation of the pre-clinical trials' results and assessment of the possibility
of carrying out clinical trials of medicinal products on the territory of
Russia, including international multicentre clinical trials;
 laboratory evaluation (testing) of medicinal products quality as part of their
registration;
 carrying out scientific research, working out guidance documents related to
quality, efficacy and safety of medicinal products, drawing up
pharmacopoeial monographs for the state pharmacopoeia, organization of
training workshops
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FSBI «SCIENTIFIC CENTRE FOR EXPERT
EVALUATION OF MEDICINAL PRODUCTS»
OF THE MINISTRY OF HEALTH

14. CENTRE OF PHARMACOPOEIA AND INTERNATIONAL
COOPERATION
 Preparation of the first State Pharmacopoeia in the contemporary history of Russia (SPh
XII) – 5 parts
2008 - I part SPh XII
2011 - II part SPh XII – description of physical, physical-chemical and chemical methods of
analysis, pharmacotechnological tests
2012 - III part SPh XII – General pharmacopoeia monographs for immunobiological products
and methods of analysis, general requirements for dosage forms and medical products
2013 - IV part SPh XII – herbs and herbal medicinal products
2013-2014 - V part SPh XII – homeopathic medicines and methods of their analysis
 Participation in the work of the European Pharmacopoeia Commission aimed at
international harmonization of quality standards of domestic medicinal products
Reference. The Russian Federation has a status of the Observer State in the European
Pharmacopoeia Commission
 Elaboration of programs for harmonization of Russian national standards with normative
documents of the EU countries, the USA, and the CIS countries in the sphere of medicinal
products' evaluation
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FSBI «SCIENTIFIC CENTRE FOR EXPERT
EVALUATION OF MEDICINAL PRODUCTS»
OF THE MINISTRY OF HEALTH

15. Greatness is not in
where we stand,
but in what
direction we are
moving
Oliver Wendell Holmes

16. Thank you for your attention