1-2_Comparator_Selection pot

Selection of comparator Drs. Jan Welink Training workshop: Training of BE assessors, Kiev, October 2009 Training workshop: Training of BE assessors, Kiev, October 2009 2 | Introduction Quality of generics: Training workshop: Training of BE assessors, Kiev, October 2009 3 | Introduction Multi-source (generic) drug products must satisfy the same standards as those applicable to the originator’s product. In addition, reasonable assurance must be provided that they are, as intended, clinically interchangeable with nominally equivalent market products. Training workshop: Training of BE assessors, Kiev, October 2009 4 | Comparator Introducing the comparator: * a pharmaceutical product with which the multi- source product is intended to be interchangeable in clinical practice. * the selection of the comparator product is usually made at the national level by the drug regulatory authority. Training workshop: Training of BE assessors, Kiev, October 2009 5 | Comparator Introducing the comparator: innovator product, approved on full documentation: - established safety and efficacy Quality Pre-clinical Clinical Training workshop: Training of BE assessors, Kiev, October 2009 6 | Physically: WHAT IS THE DIFFERENCE BETWEEN INNOVATOR AND GENERIC? Training workshop: Training of BE assessors, Kiev, October 2009 7 | Scientifically: INNOVATOR GENERIC BE WHAT IS THE RELATION BETWEEN INNOVATOR AND GENERIC? Training workshop: Training of BE assessors, Kiev, October 2009 8 | Choice of the comparator: Training workshop: Training of BE assessors, Kiev, October 2009 9 | Comparator Selection by the DRA:  choose national granted innovator for which quality, safety and efficacy has been established (nationally authorised innovator)  choose WHO comparator product from the comparator list (WHO comparator product)  choose innovator product from well-regulated country (ICH et al. innovator)  if no innovator can be identified, choice must be justified Training workshop: Training of BE assessors, Kiev, October 2009 10 | Comparator Justification if no innovator can be identified:  approval in ICH- and associated countries  pre-qualified by WHO  extensive documented use in clinical trials (reports)  long and unproblematic post-market surveillance . | Comparator Introducing the comparator: * a pharmaceutical product with which the multi- source product is intended to be interchangeable in clinical practice. * the selection of the comparator. assessors, Kiev, October 2009 8 | Choice of the comparator: Training workshop: Training of BE assessors, Kiev, October 2009 9 | Comparator Selection by the DRA:  choose national granted innovator. efficacy has been established (nationally authorised innovator)  choose WHO comparator product from the comparator list (WHO comparator product)  choose innovator product from well-regulated country