2. Transatlantic Administrative Simplification Workshop European Preparatory Roundtable 8.6.2007 Suzette Kox EGA Senior Director Scientific Affairs

3. Generic and Biosimilar Medicines - Public Health Increases access through affordable medicines Stimulates innovation through competition Provides budget headroom for financing genuine new innovation Develops for patients new formulations, methods of delivery, etc

4. Biosimilar Medicines Reality “ Biosimilars offer new opportunities both for the growth of our generic industry and for the control of our national health expenditure.” Günter Verheugen, Vice- President EU Commission (April 2006)

5. Support from EGA Global Companies Generic Medicines Industry operates more and more in a global arena today  generic medicines  biosimilar medicines Global approach to development programs is becoming more and more a NEED for generic and a MUST for biosimilar medicines

6. Scope Centralised Procedure (CP) recently open for generic applications CP mandatory for biotechnology biosimilar products applications Generic and biosimilar applications cross- refer to and perform testing with reference products

7. Generic Medicines: Issue I Where US and EU reference product is the same  Bioequivalence studies are duplicated today –Unnecessary human testing unethical  Batches of reference product used in BE study must be from US resp. EU markets

8. EGA Objective/Proposal I One bioequivalence study for EU/USA  Simplifies dossier requirements  Avoids unnecessary human testing (public health protection)  No change in legislation required Confidential exchange of information + documents regarding the reference product  along the lines what is now practiced between EU Member States

9. Global Approach to Biosimilar/FOP Development both EU and US environments Requires that a company designs its development programme to meet the scientific and regulatory criteria of both EU and US environments

10. Biosimilar Development Issue II:  Two separate scientific advice needed EGA Proposal II:  Parallel scientific advice for biosimilar development programmes

11. Biosimilar Development Issue III:  Two separate and full developments including two independent sets of preclinical and clinical phase I and phase III studies are to be made today EGA Proposal III:  To bridge between the two independent developments and to reduce preclinical and clinical studies to the minimum requirements

12. EGA Proposal III (contd.) Perform phase I studies with the EU and the US reference products only to be able to build the bridge to the clinical phase III studies which are performed with either the US or the EU product  provided phase I studies performed with EU and US products reveal same results

13. EGA Proposal III (contd.) EMEA/FDA to accept a part of the development to be performed with either the EU or US reference product (providing the reference product is the same or highly similar)

14. EGA Issue/Objective IV If the same biological reference product is authorised in the EU and the USA, manufactured in the USA and batch released into the EU, EMEA, as per scientific advice, does not allow using batches from the US market for the comparability exercise Objective: to be able to use batches of the US reference products for the comparability exercise and vice versa, if the same reference product is authorised in the EU and the USA

15. How to Achieve EGA Proposals I-IV? Through bilateral work  i.e. widen the scope of existing EU-US confidentiality arrangements for medicinal products  EU-US confidentiality arrangement sets the basis for exchange of information between the agencies –This framework should allow confidential exchange of information and documents regarding reference biological products between the EMEA and the FDA

16. General Issue Inspections of drug product and drug substance manufacturers are performed separately by the Unites States and EU Inspectors  leads to duplication of inspections  increase of costs for both regulators and industry  is a source of delay in inspections

17. EGA Proposal V Reopen Mutual Recognition Agreement of inspections between the Unites States and the EC  Scope of MRA to be defined  Look also into new concepts like team inspections currently explored by the Pharmaceutical Inspection Co-operation Scheme (PIC/S)  Work to be done through past MRA framework

18. EU-US Workshop on Administrative Simplification Thank you!