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Generic substitution and licensing

Generic substitution and licensing. PDIG Summer Symposium 10 June 2010. Generic substitution. What’s a generic medicine?. Legally. Practically.

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Generic substitution and licensing

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  1. Generic substitution and licensing PDIG Summer Symposium 10 June 2010

  2. Generic substitution

  3. What’s a generic medicine? Legally Practically “‘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]

  4. Definitions

  5. National comparisons

  6. Benefits of generic medicines

  7. Life cycle relationship with original brands Brand monopoly Generic competition Launch of original brand Launch of subsequent generics Effective patent / SPC protection of original brand * Development of original brand Development of generics Brand Average brand cost= £20.00 Average generic cost = £3.83 NHS saving due to generic competition = £8.6bn per year for England Launch of first generic Brand Price Generic * Includes patent, patent extension, data exclusivity, paediatric exclusivity, etc

  8. Substitution consultation

  9. Issues raised

  10. Issues raised

  11. BGMA position

  12. BGMA principles

  13. Generic licensing

  14. Abridged procedure

  15. Abridged procedure Assessment to current EU standards Research & development Dossier • EU guidelines • Bioequivalence – guideline updated 2010 • Product development -identical standards to innovator with benefits of technical advance SmPC and PIL/Label Validation First Assessment (medic, pharmacist, toxicologist, statistican) Questions to company Answers to MHRA Q+A repeated until MHRA satisfied Marketing Authorisation Granted Clinical & Toxicology. Refer to innovator, not repeated Launch at patent off Bioequivalence Clinical link • Chemistry and Pharmacy • Drug Substance • Drug Product 18 months 18 – 24 months

  16. Reasons for different indications

  17. Impact

  18. Thank you … … And questions

  19. Members and Contact Warwick Smith Director-General British Generic Manufacturers Association The Registry Royal Mint Court London EC3N 4QN T: +44 20 7457 2065 M: +44 7974 565 424 E: warwick.smith@britishgenerics.co.uk W: www.britishgenerics.co.uk

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