4. Prof. Shinar Baidullaeva - National Center for Medicines, Medical Devices and Medical Equipment Expertise (Republic of Kazakhstan)


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“The approaches to the regulation of biological medicinal products in the Republic of Kazakhstan”

Illustrates the current norms in place in Kazakhstan for the marketing authorization of pharmaceutical products and the dossier requirements for biotherapeutics & biosimilars

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4. Prof. Shinar Baidullaeva - National Center for Medicines, Medical Devices and Medical Equipment Expertise (Republic of Kazakhstan)

  1. 1. The approaches to the regulation of biologicalmedicinal products in the Republic of KazakhstanThe National Center for Drug Expertise, Medical items and EquipmentMinistry of Public HealthRepublic of KazakhstanSh. BaidullayevaHead of Department for Pharmacological Assessment15-16 мая 2013, МоскваБиотерапевтические препараты. Современные вызовы и регуляторные практики. Подходы кгармонизации.
  2. 2. Pharmaceutical marketing authorizationpathway in KazakhstanMPhACC’s** as a regulatorybody Kazakhstan Ministry ofPublic healthMPhACC’s** as a regulatorybody Kazakhstan Ministry ofPublic healthThe National Center for DrugExpertise, Medical items andEquipment’s on expert body inmedicinal products regulationRegistration dossierMinistryofPublicHealthRegistrationdossierassessmentMarketing authorization’sbased on positiveconclusions of the NCDE**NCDE - The National center for drug expertise, medicalitems and equipment**MPhACC - the Medical and Pharmaceutical activitycontrol Committee
  3. 3. NCDE’s main unitsMedicinal product Medical devicesPrimary expertise department Primary expertise departmentDepartment for PharmaceuticalAssessmentDepartment for Medical devicesAssessmentDepartment for PharmacologicalAssessmentLabsPhysical Chemistry LabMicrobiologically LabRepublican immunobiological labPharmacological Lab/BA&BE LabAnimal house Group on non-clinical&clinical studies Department for quality&safety assessment(certification) 11 regional branches
  4. 4. http://www.dari.kz
  5. 5. Pharmaceutical marketing authorizationrules have been defined by:the Kazakhstan Health Code(18.09.2009)the MoH Orders under №735(18.11.2009) and 736 (18.11.2009)
  6. 6. Registration dossier assessmentRegistration dossier assessment by NCDE consists of 4 consecutivestages:1) primary expertise – the main aim’s to check the registration dossiercompleteness for meeting current requirements, adequacy of the finishedproduct and reference standards samples for a three-time analysis2) analytical tests at the test lab –the aim’s to perform tests for checkingthe quality of FPS to be in conformity with an Analytical normative documentdeveloped in accordance with Finished product specification and KazakhstanPharmacopeia, EPh, USP, BP3) pharmaceutical assessment – it’s an expertise of pharmaceutical part ofthe dossier, namely development pharmaceutical form, manufacturing,impurities assessment, data stability, etc.4) pharmacological assessment – it’s an expertise conducted forpharmacological part of the dossier, namely non-clinical studies&clinical trialsdata, pharmacovigilance , Risk management plan
  7. 7. BiosimilarsUp to September, 2009, there hadn’t been anyrequirement for marketing authorization ofbiosimilars in KazakhstanIn the Kazakhstan Health Code the firstdefinition of “biosimilars” was accepted onlyin September, 2009
  8. 8. Definitions “Biological medicinal product”and “Biosimilars”Biological medicinal products are the products containing biological proteins(hormones, cytokines, blood clotting factors, including low molecular weight heparin,insulin, monoclonal antibodies, enzymes, colony stimulating factors, products thathave been developed on the basis of tissue cells obtained by genetic engineering andhybridoma technology)Biosimilars is a reproduced biological medicinal product that is claimed to be similar inquality, safety and efficacy to innovative reference biological medicinal product with asimilar international non-proprietary name that has been registered beforeThe Kazakhstan Health Code of Republic (18.09.2009)
  9. 9. Dossier RequirementsFor marketing authorization of the originalmedicinal product, includingimmunotherapeutic and radiopharmaceuticalproducts, an applicant for registration providesthe whole list for the required registrationdossierMoH Order under №735 dated 18/11/2009,paragraph 15
  10. 10. Dossier Requirements for biosimilarIt is necessary to provide the following data for biosimilar marketingauthorization:- active substance and finished product of biosimilar quality datacompared with the original biological product-reports on comparative preclinical studies of biosimilar and originalbiological product-reports on biosimilar safety, efficacy and immunogenicity throughcomparative clinical trials versus original biological product- Pharmacovigilance Master File marketing authorization holder and Riskmanagement plan for the proposed productMoH Order under №735 dated 18/11/2009,paragraph 23
  11. 11. Kazakhstan record book makes 7131 medicinal products by 10thMay 2013,with it all 296 is biological medicinal productsRegistered under the following biological productgroups:VaccinesInsulinMonoclonal antibodyErythropoietin Low-molecular-weight heparinsInterferonGranulocyte-colony stimulating factorSomatropin
  12. 12. The following product bracketshave been applied for registration as biosimilrs from 2010 to 2012Active substance name Number application DecisionPeg interferon (India) 1 RefusedErythropoietin (Korea) 1 RefusedLow-molecular-weightheparin (India)2 RefusedSomatropin (Russia) 1 RefusedInterferon beta (Ukraine) 1 Refused
  13. 13. Refusal for registration- No proof for quality, purity and potency similarity withthe reference biological product- The lack of comparative non-clinical studies&clinical trials- Multi-reference for different stages of productdevelopment (quality tests, preclinical and clinicalstudies)- The lack of Risk management plan
  14. 14. The following product bracketshave been applied for registration as biosimilrs in 2013Active substance name NumberapplicationDecisionLow-molecular-weight heparin (India) 1 UnderreviewThe monoclonal antibody -Infliximab (Korea)1 UnderreviewThe monoclonal antibody Rituximab(India)1 Underreview
  15. 15. Reference Biological medicinal product The original biological product is the reference product In case of non-availability of the original biological productin Kazakhstan, there is an option to regard the authorizedproducts in the ICH-countries
  16. 16. National Center for Drug Expertise makes use of EuropeanMedicines Agency guidelines over biosimilar registration dossierassessment
  17. 17. The reproduced Insulin productsMarketing authorization was granted before September,2009, for some insulin products (India, Ukraine, Poland)However they are not considered as biosimilarsand are not use in clinical practice
  18. 18. Amendments to authorizationrequirementsReproduced biological medicinal productsregistered earlier than 2009, upon maturitydeadline will be submitted for registration,however not for re-registration , in accordancewith biosimilars requirementsDraft Amendment to MoH Order №735
  19. 19. Thank you for attention!Thank you for attention!Charyn Canyon