Biosimilars and Generics                  Russia
Biosimilars and Generics: Russia             18-20 September, 2012                 Istanbul, TurkeyNatalia Salamova, Busin...
Content•   Biosimilars vs./and generics:    general notions•   Market interest for biosimilars    and generics            ...
Patented medicinal products                              Source: IMS Health
Generics vs. Biosimilars: definitions (Russia)           • Generic drugs           Drugs having the same active pharmaceut...
Generics vs BiosimilarsGenerics                             Biosimilars• Mostly small molecules             • Large comple...
Generics: advantages• Efficient pharmacoeconomic  parameters• Higher availability for patients• New opportunities for comp...
Generics: general statistics (Russia)• 2nd quarter of 2012: > 250 clinical trials approved• Bioequivalence studies: > 100 ...
Generics: regulatory basis  • Federal Law No. 61 On Medicinal    Products Circulation as of April 12,    2010  • Guideline...
General provisions (I)• A minimum of 18 healthy volunteers aged 18-  45• Cross-over design (mostly)• Usually under fasting...
General provisions (II)Objects of b/e studies – medicinal drugs aimed for administration:   - orally (tablets, capsules, s...
Regulatory pathway (I)                      Documents                      from CRO          Ministry of Healthcare of    ...
Generics: issues to consider   • Pre-clinical studies for the generic     product (comparative acute, sub-     acute toxic...
Part II: Biosimilars in RussiaVladimir Chistyakov
Biosimilars in Russia: facts• Currently, the legislation in Russia does not contain  a definition for biosimilar drugs• Th...
Examples of approved clinical trials in Russia with               biosimilars (2011-2012)• Rituximab:   •   TL011 (Teva)  ...
Non-clinical development of biosimilars         In vitro studies             • Characterization of the chemical           ...
Clinical development of biosimilars      A study to show comparable pharmacokinetics         and pharmacodynamic (PD) effe...
Clinical development of biosimilars (II)• A study to show comparable safety and efficacy of biosimilar  drug and originato...
Services provided by OCT• Consulting                  • Logistics support• Medical writing             • Quality assurance...
ContactRussia                                             BulgariaHEADQUARTERS:                                  Sofia, di...
Thank you for your time and interest!     Contact OCT:info@oct-clinicaltrials.com
Qualified clinical Investigators with experience      in ICH-GCP compliant industry-driven studywww.oct-clinicaltrials.com
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Generics And Biosimilars

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Generics And Biosimilars

  1. 1. Biosimilars and Generics Russia
  2. 2. Biosimilars and Generics: Russia 18-20 September, 2012 Istanbul, TurkeyNatalia Salamova, Business Development Manager Vladimir Chistyakov, Medical Writer
  3. 3. Content• Biosimilars vs./and generics: general notions• Market interest for biosimilars and generics Generics Biosimilars• Generics: facts and figures • Biosimilars: facts and figures• Generics: regulatory • Biosimilars: regulatory issues environment • Biosimilars: challenges• Generics: challenges• OCT experience• Documents submission• Perspectives
  4. 4. Patented medicinal products Source: IMS Health
  5. 5. Generics vs. Biosimilars: definitions (Russia) • Generic drugs Drugs having the same active pharmaceutical substance (or a combination of substances) in the same administration form as the original patented medicinal product and entering the market after the originator product • Biosimilars Immunobiological medicinal products – drugs of biological origin aimed at immunological diagnostics, prophylactics, treatment of diseases
  6. 6. Generics vs BiosimilarsGenerics Biosimilars• Mostly small molecules • Large complex molecules• Produced by means of • Produced by living organisms chemical synthesis• Essentially similar medicinal • Similar biological medicinal product product• Easily reproduced • Manufacturing production sensitive• Abbreviated pre-clinical • Extensive pre-clinical studies studies profile• Standardized study designs for • Sophisticated design for clinical development clinical development• Standardized bio-analytical • More complex bioanalytical part part
  7. 7. Generics: advantages• Efficient pharmacoeconomic parameters• Higher availability for patients• New opportunities for companies
  8. 8. Generics: general statistics (Russia)• 2nd quarter of 2012: > 250 clinical trials approved• Bioequivalence studies: > 100 (≈ 40%) Source: Orange Paper
  9. 9. Generics: regulatory basis • Federal Law No. 61 On Medicinal Products Circulation as of April 12, 2010 • Guidelines on Bioequivalence Assessment of Medicinal Products as of 2008 • GOST R 52379-2005 “Good clinical practice” • ICH-GCP Guidelines
  10. 10. General provisions (I)• A minimum of 18 healthy volunteers aged 18- 45• Cross-over design (mostly)• Usually under fasting conditions• Wash-out period – minimum 6 T ½• Active substance concentration assessment within 4 T ½• Active substance concentration assessed in whole blood, plasma, serum• Equivalence margins for Cmax are 0.75 – 1.33• In case of psychoactive, anti-tumor, HIV drugs, and highly toxic drugs – studies in patients
  11. 11. General provisions (II)Objects of b/e studies – medicinal drugs aimed for administration: - orally (tablets, capsules, suspensions, etc.) - by skin application, - rectally and vaginallyproviding that its efficacy is mediated by the appearance of the active substance in the systematic blood circulation. BE studies are not conducted for medicinal products designed for:- inhalation,- injection,- infusion,- oral solution,- eye drops,- drugs of topical action.
  12. 12. Regulatory pathway (I) Documents from CRO Ministry of Healthcare of CT 60 days the Russian Federation approval 30 daysFederal State Budget Ethics Council within Ministry ofInstitution “Scientific the Ministry of Healthcare of the Local EcsCentre for Evaluation Healthcare of the Russian Federationof Medicinal Products” Russian Federation (Import/Export)
  13. 13. Generics: issues to consider • Pre-clinical studies for the generic product (comparative acute, sub- acute toxicity). Literature data are not applicable • Lack of commercial phase I units • Lack of GLP laboratories • Import of investigational product substance for pre-clinical studies and for method validation
  14. 14. Part II: Biosimilars in RussiaVladimir Chistyakov
  15. 15. Biosimilars in Russia: facts• Currently, the legislation in Russia does not contain a definition for biosimilar drugs• There are no official documents in Russia describing regulatory requirements for the quality, non-clinical and clinical studies for biosimilars But:• Biosimilar and biobetter drugs are under development in Russia• A number of clinical studies with biosimilar drugs have been approved by the Russian Ministry of Health
  16. 16. Examples of approved clinical trials in Russia with biosimilars (2011-2012)• Rituximab: • TL011 (Teva) • CT-P10 (Celltrion) • GP2013 (Hexal AG) • Rituximab (Biocad)• Filgrastim: • Tevagrastim (Teva) • MK-4214 (Merck) • EP2006 (Sandoz)• Avastin: • BCD-02 (Biocad) Source: http://www.grls.rosminzdrav.ru/
  17. 17. Non-clinical development of biosimilars In vitro studies • Characterization of the chemical structure of the biosimilar drug • Comparative studies of pharmacodynamic effects In vivo studies • Comparative studies of efficacy • Comparative safety and toxicology studies in animals Source: http://www.grls.rosminzdrav.ru/
  18. 18. Clinical development of biosimilars A study to show comparable pharmacokinetics and pharmacodynamic (PD) effects of the biosimilar drug and originator product, points to consider: • Study population: patients vs. healthy volunteers • PK parameters of interest • Availability of relevant PD markers • Number of study subjects • Overall cost of the study including comparator drug cost
  19. 19. Clinical development of biosimilars (II)• A study to show comparable safety and efficacy of biosimilar drug and originator product: • “If dose comparative and highly sensitive PD studies cannot be performed convincingly showing comparability in a clinically relevant manner, similar clinical efficacy between the similar and the reference product should be demonstrated in adequately powered, randomised, parallel group comparative clinical trial(s), preferably double-blind, normally equivalence trials.”
  20. 20. Services provided by OCT• Consulting • Logistics support• Medical writing • Quality assurance, Audits• Feasibility assessment • Purchase of concomitant• Project management medication• Regulatory support • Data management• Clinical monitoring • Statistics• CRA training • Safety Management
  21. 21. ContactRussia BulgariaHEADQUARTERS: Sofia, district Triaditza, 53, Tzarigradsko Shosse,8/2 Bolshaya Moskovskaya Str., Suite 4-1 Blvd., bl. 2, floor 1, Apt. 4St.Petersburg, 191002, RussiaMOSCOW OFFICE: The Baltic StatesGamsonovsky per. 2, building 2, Suite 77-82, Bauskas str. 33-4Moscow 115191, Russia Riga, LV-1004, LatviaUSA BD Office Belarus845 Third Avenue, 6th Floor Severny per. 13/2, Suite 3New York, NY 10022, US Minsk, 220036, BelarusUkraine34 Lesi Ukrainki Str., Suite 219PO box 50, 01601, Kiev, Ukraine
  22. 22. Thank you for your time and interest! Contact OCT:info@oct-clinicaltrials.com
  23. 23. Qualified clinical Investigators with experience in ICH-GCP compliant industry-driven studywww.oct-clinicaltrials.com

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