Clinical aspects of Intercheangibility, substitution andtherapeutic switch of Biological Medicinal Products.From the Medic...
Biosimilar medicinal product means a biological medicinal product with quality, efficacyand safety parameters similar to t...
What are we (patients and physicians)afraid of?• The existing chemical structure differencesbetween the biosimilar and the...
Biosimilars: Existing Approaches• Biosimilar = genericSimplified registration procedureafter minimal clinical trials
Filgrastims registered in RF, May 2013 (GRLS, MoH)Trade name Manufacturer MA status CountryGranogen® Pharmapark LLC Valid ...
An efficient originator medicinal product mustnot be substituted with a biosimilar (?) withunknown properties.
Interchangeability-substitution is notacceptable due to the following reasons:• Insufficient pharmacovigilance system &sup...
An interchangeable medicinal product is a medicinal product, other than a biologicalmedicinal product, with proven therape...
But if interchangeability is prohibited, there areno incentives to create and manufacturebiosimilars.
When interchangeability can be allowed?
Drugs that proved theirpharmacological and clinicalcomparability (conventional identity)are interchangeable-(with certain ...
Streamlining biosimilar study and registration• Pre-clinical trials (intensive study of action mechanisms; invitro/in vivo...
The changes planned do not describe any requirements to registration of biosimilarsMINISTRY OF HEALTH OF THE RUSSIAN FEDER...
Outstanding issues in biosimilars’ registrationand clinical application• Extrapolation to other clinical indications;• Imm...
Outstanding issues in biosimilars’ registrationand clinical application• Extrapolation to other clinical indications;• Imm...
Regulatory Agency Structure and cooperation
Regulatory Cooperation
Issue of Biosimilars
29. Prof. Sergey Tulyandin - Russian Scientific Oncology N.N. Blokhin Center
29. Prof. Sergey Tulyandin - Russian Scientific Oncology N.N. Blokhin Center
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29. Prof. Sergey Tulyandin - Russian Scientific Oncology N.N. Blokhin Center

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“Clinical aspects of Interchangeability, substitution and therapeutic switch of Biological Medicinal Products. From the Medical Community Point of View”

Provides an overview of the concerns around interchangeability and automatic substitution from the perspective of the physicians and the patients

Published in: Health & Medicine, Business
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29. Prof. Sergey Tulyandin - Russian Scientific Oncology N.N. Blokhin Center

  1. 1. Clinical aspects of Intercheangibility, substitution andtherapeutic switch of Biological Medicinal Products.From the Medical Community Point of View.S.A. TjulandinRussian Academy of Medical Science,N.N. Blokhin Russian Cancer Research CenterMoscowRussian Society of Clinical Oncology (RUSSCO)www.rosoncoweb.ru
  2. 2. Biosimilar medicinal product means a biological medicinal product with quality, efficacyand safety parameters similar to the originator biological medicinal product in the samedosage formMINISTRY OF HEALTH OF THE RUSSIAN FEDERATION Site search:News Ministry Pool of Documents Public Reception Room Events Contact UsHome Pool of Documents Draft Regulations Draft Federal Law dated May 6, 2013Forward MS Word Version Printable VersionDraft Federal Law dated May 6, 2013On Making Amendments to Federal Law on Circulation of Medicines and to Article333.32.1, Part 2, Tax Code of the Russian Federation
  3. 3. What are we (patients and physicians)afraid of?• The existing chemical structure differencesbetween the biosimilar and the originatormedicinal product may:– Lead to clinically significant changes in the drugefficacy;– Increase toxicity and, in particular, frequency ofcomplications caused by the drug immunogenicity.
  4. 4. Biosimilars: Existing Approaches• Biosimilar = genericSimplified registration procedureafter minimal clinical trials
  5. 5. Filgrastims registered in RF, May 2013 (GRLS, MoH)Trade name Manufacturer MA status CountryGranogen® Pharmapark LLC Valid RussiaGranulocyte colonystimulating humanrecombinant factor (rhG-CSF)Vector VB GNTs FGUN of the FederalService for Human Rights andConsumer Welfare valid RussiaGrasalva Lemeri S.A. De S.V. valid MexicoZarsio I.D.T. Biologika GmbH valid GermanyImmugrast® Dr. Reddi’s Laboratories Ltd. valid IndiaLeucostim® Biocad CJSC valid RussiaLeucyta BEG Health Care GmbH valid GermanyMyelastra Lance-Pharm LLC valid RussiaNeupogen® F.Hoffmann La Roche Ltd. valid SwitzerlandNeupomaxPharmstandard – Ufa Vitamin PlantOJSC valid RussiaNeutrostim®Vector – Main Scientific Center forVirusology and Biotechnology valid RussiaTevagrastim Lemeri S.A. De S.V. valid MexicoFilgrastim Masterclon CJSC valid RussiaFilgrastim Pharmapark LLC valid RussiaFilgrastimShandung Casing Bioproducts Co.Ltd. valid ChinaFilergim® Intas biopharmaceuticals Ltd. valid India
  6. 6. An efficient originator medicinal product mustnot be substituted with a biosimilar (?) withunknown properties.
  7. 7. Interchangeability-substitution is notacceptable due to the following reasons:• Insufficient pharmacovigilance system &supervision;• Absence of GMP at most pharmaceuticalproduction facilities in Russia;• Inadequate quality control by the state.
  8. 8. An interchangeable medicinal product is a medicinal product, other than a biologicalmedicinal product, with proven therapeutic equivalence to the originator medicinalproductMINISTRY OF HEALTH OF THE RUSSIAN FEDERATION Site search:News Ministry Pool of Documents Public Reception Room Events Contact UsHome Pool of Documents Draft Regulations Draft Federal Law dated May 6, 2013Forward MS Word Version Printable VersionDraft Federal Law dated May 6, 2013On Making Amendments to Federal Law on Circulation of Medicines and to Article333.32.1, Part 2, Tax Code of the Russian Federation
  9. 9. But if interchangeability is prohibited, there areno incentives to create and manufacturebiosimilars.
  10. 10. When interchangeability can be allowed?
  11. 11. Drugs that proved theirpharmacological and clinicalcomparability (conventional identity)are interchangeable-(with certain assumptions)
  12. 12. Streamlining biosimilar study and registration• Pre-clinical trials (intensive study of action mechanisms; invitro/in vivo efficacy and toxicity as compared with theoriginator medicinal product).• Clinical trials– Pharmacological comparability (pharmaco-kinetic trial in comparisonwith the originator medicinal product, in healthy volunteers orpatients);– Therapeutic comparability (Phase III comparable study to assessefficacy and toxicity of the originator medicinal product and thebiosimilar in terms of some particular indication in a homogenouspatient group).• PharmacovigilanceЕMA, 2012
  13. 13. The changes planned do not describe any requirements to registration of biosimilarsMINISTRY OF HEALTH OF THE RUSSIAN FEDERATION Site search:News Ministry Pool of Documents Public Reception Room Events Contact UsHome Pool of Documents Draft Regulations Draft Federal Law dated May 6, 2013Forward MS Word Version Printable VersionDraft Federal Law dated May 6, 2013On Making Amendments to Federal Law on Circulation of Medicines and to Article333.32.1, Part 2, Tax Code of the Russian Federation
  14. 14. Outstanding issues in biosimilars’ registrationand clinical application• Extrapolation to other clinical indications;• Immunogenicity;• Switch from the original medicinal product to thebiosimilar and back (multiple) and developmentaltoxicity assessment.Thus, there can be no automaticinterchangeability=substitution (it does not existanywhere in Europe)
  15. 15. Outstanding issues in biosimilars’ registrationand clinical application• Extrapolation to other clinical indications;• Immunogenicity;• Transfer from the original medicinal product to thebiosimilar and back (multiple) and developmentaltoxicity assessment.Thus, there can be no automaticinterchangeability=substitution (it does not existanywhere in Europe)
  16. 16. Regulatory Agency Structure and cooperation
  17. 17. Regulatory Cooperation
  18. 18. Issue of Biosimilars
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