Generic substitution and licensing

PDIG Summer Symposium

10 June 2010

Generic substitution

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What’s a generic medicine?

“‘generic medicinal product’ shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. [...]”

[Art 10.2(b),Directive 2001/83/EC, as amended]

PracticallyLegally

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Definitions

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National comparisons

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Benefits of generic medicines

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Life cycle relationship with original brands

Development of original

brand

Launch of original brand

Effective patent / SPC protection of original

brand *

Development of generics

Launch of first generic

Launch of subsequent

generics

Generic competition Brand monopoly

Price

Generic

Average brand cost= £20.00

Average generic cost = £3.83

NHS saving due to generic competition = £8.6bn per year for England

Brand

Brand

7* Includes patent, patent extension, data exclusivity, paediatric exclusivity, etc

Substitution consultation

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Issues raised

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Issues raised

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BGMA position

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BGMA principles

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Generic licensing

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Abridged procedure

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Abridged procedure

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•EU guidelines

•Bioequivalence – guideline updated 2010

•Product development -identical standards to innovator with benefits of technical advance

SmPC and PIL/Label

Clinical & Toxicology.Refer to innovator, not repeated

BioequivalenceClinical link

Chemistry and Pharmacy•Drug Substance•Drug Product

1. Validation

2. First Assessment (medic, pharmacist, toxicologist, statistican)

3. Questions to company

4. Answers to MHRA

5. Q+A repeated until MHRA satisfied

6. Marketing Authorisation Granted

Launch at patent off

18 – 24 months 18 months

Research & development

Dossier Assessment to current EU standards

Reasons for different indications

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Impact

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Thank you …… And questions

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Members and Contact

Warwick SmithDirector-GeneralBritish Generic Manufacturers AssociationThe RegistryRoyal Mint CourtLondon EC3N 4QN

T: +44 20 7457 2065M: +44 7974 565 424E: warwick.smith@britishgenerics.co.ukW: www.britishgenerics.co.uk

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