Generic substitution and licensing
description
Transcript of Generic substitution and licensing
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: [email protected]: www.britishgenerics.co.uk
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