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Note on Choice of Comparator Products: Current status

Note on Choice of Comparator Products: Current status. Note to Applicants on Choice of Comparator Products in the Prequalification Project: First draft (Jan. 2005) was circulated among experienced assessors from several countries Now published on the WHO website . Note on Choice of Comparator.

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Note on Choice of Comparator Products: Current status

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  1. Note on Choice of Comparator Products: Current status • Note to Applicants on Choice of Comparator Products in the Prequalification Project: • First draft (Jan. 2005) was circulated among experienced assessors from several countries • Now published on the WHO website TANZANIA 21-25 August 2006

  2. Note on Choice of Comparator • Objective: • This note is intended to provide to applicants some additional guidance and clarification on existing guidance documents how to select an appropriate comparator product for a bioequivalence study necessary for generic products submitted into the WHO prequalification project . TANZANIA 21-25 August 2006

  3. Note on Choice of Comparator • The following information is already provided on the web site,see (http://mednet3. who.int/prequal/ , Documents and Materials, Bio-equivalence): • “What data and information needs to be submitted in a dossier for a generic product?” • “A set of bio-equivalence study data is required for all oral preparations” !!!!!! TANZANIA 21-25 August 2006

  4. Note on Choice of Comparator • With regard to the choice of comparator products reference is made on the website to “International comparator products for bio-equivalence testing" • Annex 11 of Thirty-sixth Report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. WHO Technical Report Series, No. 902, 2002: 161-180:Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products. [Annex 11] TANZANIA 21-25 August 2006

  5. Note on Choice of Comparators: General comments: • The innovator pharmaceutical product is usually the most logical comparator product for a multisource pharmaceutical product because its quality, safety and efficacy should have been well assessed and documented in premarketing studies and post-marketing monitoring schemes. TANZANIA 21-25 August 2006

  6. Note on Choice of Comparators: General comments: • Whenever possible the innovator products should be obtained from a well regulated market with stringent regulatory authority (countries such as Australia, Canada, European Union Member States, Japan, USA, Switzerland) , and the Product Information (or Summary of Product Characteristics) of the respective country should be used for reference. TANZANIA 21-25 August 2006

  7. Note on Choice of Comparators: General comments: • Never should a generic drug be used as comparator as long as an innovator drug is available, because this could lead to a “bio-creep” phenomenon, resulting in progressively less reliable similarity of future multisource products and to lack of interchangeability with the innovator. TANZANIA 21-25 August 2006

  8. „Bio-Creep“ Interchangeable Not Interchangeable TANZANIA 21-25 August 2006

  9. Note on Choice of Comparators: General comments, FDC: • Similar considerations apply to the use of fixed-dose-combinations, which were approved exclusively on the basis of bioequivalence studies comparing with the individual components, which were used as free combinations (i.e. individual products co-administered) in efficacy and safety studies. TANZANIA 21-25 August 2006

  10. Note on Choice of Comparators: General comments, FDC: • Such FDC’s should normally not be used as comparators – even if approved by ICH countries – instead again the individual components should be used as comparators. • However, there are also some fixed-dose-combinations which were used as such extensively in clinical trials, thus direct, “own” evidence for their efficacy and safety is available. These can be used !!! TANZANIA 21-25 August 2006

  11. Note on Choice of Comparators: Example for 4-FDC: • Bioequivalence study, 1999, accepted in EU, Switzerland and by WHO:   • Rimstar 4-FDC® versus • Rimactane ® + Isozid ® + Rolab Pyrazinamide ® + Myambutol® TANZANIA 21-25 August 2006

  12. Note on Choice of Comparators: Example for 4-FDC: • Rimstar 4-FDC® (Rifampicin 150, Isoniazid 75, Pyrazinamide 400, Ethambutol 275mg) 4 tablets given in a single dose versus • Rimactane ® (Novartis, Switzerland*) 4 capsules each containing 150mg rifampicin • Isozid ® (Fatol, Germany) 3 tablets each containing 100 mg isoniazid • Rolab Pyrazinamide ® (Rolab, South Africa) 3 tablets each containing 500 mg Pyrazinamide • Myambutol® (Lederle Arzneimittel GmbH & Co) 2 tablets containing 400mg and 3 tablets containing 100mg ethambutol TANZANIA 21-25 August 2006

  13. Thank you for your attention TANZANIA 21-25 August 2006

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