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OCT presentation on Generics and Biosimilars in Russia
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Biosimilars and Generics Russia
Biosimilars and Generics: Russia
18-20 September, 2012 Istanbul, Turkey
Natalia Salamova, Business Development Manager
Vladimir Chistyakov, Medical Writer
• Biosimilars vs./and generics: general notions
• Market interest for biosimilars and generics
Generics • Generics: facts and figures • Generics: regulatory
environment • Generics: challenges
• OCT experience • Documents submission • Perspectives
Content
Biosimilars • Biosimilars: facts and figures • Biosimilars: regulatory issues • Biosimilars: challenges
Patented medicinal products
Source: IMS Health
• 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
Generics vs. Biosimilars: definitions (Russia)
Generics • Mostly small molecules • Produced by means of
chemical synthesis • Essentially similar medicinal
product • Easily reproduced
• Abbreviated pre-clinical
studies • Standardized study designs for
clinical development • Standardized bio-analytical
part
Generics vs Biosimilars
Biosimilars • Large complex molecules • Produced by living organisms
• Similar biological medicinal
product • Manufacturing production
sensitive • Extensive pre-clinical studies
profile • Sophisticated design for
clinical development • More complex bioanalytical
part
• Efficient pharmacoeconomic parameters
• Higher availability for patients
• New opportunities for companies
Generics: advantages
• 2nd quarter of 2012: > 250 clinical trials approved • Bioequivalence studies: > 100 (≈ 40%)
Generics: general statistics (Russia)
Source: Orange Paper
• 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
Generics: regulatory basis
• 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
General provisions (I)
Objects of b/e studies – medicinal drugs aimed for administration: - orally (tablets, capsules, suspensions, etc.) - by skin application, - rectally and vaginally providing 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.
General provisions (II)
Regulatory pathway (I)
Ministry of Healthcare of the Russian Federation (Import/Export)
Documents from CRO
Ministry of Healthcare of the Russian Federation
Federal State Budget Institution “Scientific Centre for Evaluation of Medicinal Products”
Local Ecs Ethics Council within the Ministry of Healthcare of the Russian Federation
60 days CT
approval
30 days
• 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
Generics: issues to consider
Part II: Biosimilars in Russia Vladimir Chistyakov
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
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/
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/
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
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.”
• Consulting
• Medical writing
• Feasibility assessment
• Project management
• Regulatory support
• Clinical monitoring
• CRA training
Services provided by OCT
• Logistics support
• Quality assurance, Audits
• Purchase of concomitant
medication
• Data management
• Statistics
• Safety Management
Contact
Russia HEADQUARTERS: 8/2 Bolshaya Moskovskaya Str., Suite 4-1 St.Petersburg, 191002, Russia
MOSCOW OFFICE: Gamsonovsky per. 2, building 2, Suite 77-82, Moscow 115191, Russia USA BD Office 845 Third Avenue, 6th Floor New York, NY 10022, US Ukraine 34 Lesi Ukrainki Str., Suite 219 PO box 50, 01601, Kiev, Ukraine
Bulgaria Sofia, district Triaditza, 53, Tzarigradsko Shosse, Blvd., bl. 2, floor 1, Apt. 4 The Baltic States Bauskas str. 33-4 Riga, LV-1004, Latvia Belarus Severny per. 13/2, Suite 3 Minsk, 220036, Belarus
Thank you for your time and interest!
Contact OCT: info@oct-clinicaltrials.com
Qualified clinical Investigators with experience in ICH-GCP compliant industry-driven study
www.oct-clinicaltrials.com
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