transatlantic administrative simplification workshop european preparatory roundtable 8.6.2007...
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Transatlantic Administrative Simplification Workshop
European Preparatory Roundtable8.6.2007
Suzette KoxEGA Senior Director Scientific Affairs
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
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)
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
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
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
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
Global Approach to Biosimilar/FOP Development
Requires that a company designs its development programme to meet the scientific and regulatory criteria of both EU and US both EU and US environmentsenvironments
Biosimilar Development
Issue II: Two separate
scientific advice needed
EGA Proposal II: Parallel scientific
advice for biosimilar development programmes
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
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
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)
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
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 This framework should allow confidential exchange of information and documents regarding reference information and documents regarding reference biological products between the EMEA and the FDAbiological products between the EMEA and the FDA
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
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
EU-US Workshop on Administrative Simplification
Thank you!
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