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!