1. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 International Nonproprietary Names

2. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 What's in a name? Safety Quality Information Regulation Rational use use Procurement Efficacy

3. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 Verba volant scripta manent "By assigning a single international name to drugs, WHO helps ensure that a prescription filled abroad is what doctor ordered back home." Dr Margaret Chan, Director General

4. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 The WHO International Nonproprietary Name (INN) Programme To provide one single name worldwide for active pharmaceutical substances Initiated in 1950 by resolution WHA3.11 Operational since 1953 Based on WHO Constitution

5. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 INN Programme Mandated by the Member States in 1953 One of the oldest WHO programmes To devise a single name for a substance INNs are recognized in almost all Member States INNs can be used freely and cannot be registered as trade names Not concerned with formulations

6. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 Interested parties outside WHO USAN Program Pharmacopoeias (BP, FP, USP, JP….) European Commission, WCO, WIPO, … Research based industry National trade-mark authorities DRAs (EMEA, US-FDA….) INN Programme

7. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 Various trade names ® for one substance, ex. paracetamol

8. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 Various generic names for one substance, ex. paracetamol

9. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 One International Nonproprietary Name for one substance, ex. paracetamol

10. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 INNs… Unique name Distinctive in sound and spelling Not liable to confusion with other names in common use Formally placed by WHO in the public domain Can be used without any restriction to identify pharmaceutical substances

11. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 The INN System WHO Secretariat INN Expert Group INN Advisory Group on Biological Publications

12. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 The Business Process Model Broad consultation Lot of correspondence 2 INN meetings/year "Ad hoc" meetings ……

13. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 INN On Line Application Automatic Data Entry Data Validation Confidential Communication Electronic format for structures

14. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 Reaching the world  INNs Lists are published in WHO Drug Information  All INNs are published in a Cumulative List  On-line INN information: Mednet - INN Extranet Mednet - INN Extranet  Global Data Hub

15. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 INN List in practice peginterferonum beta-1a # (108) peginterferon beta-1aN 2.1 -{(2RS)-2-methyl-3-[ω-methoxypoly(oxyethylene)]propyl}human interferon beta (fibroblast interferon, IFN-beta) glycosylated expressed in mammalian cells immunomodulator péginterféron bêta-1aN 2.1 -{(2RS)-2-méthyl-3-[ω-méthoxypoly(oxyéthylène)]propyl}interféron bêta humain (interféron fibroblastoïde, IFN-bêta) glycosylé produit par les cellules de mammifères immunomodulateur peginterferón beta-1aN 2.1 -{(2RS)-2-metil-3-[ω-metoxipoli(oxietileno)]propil}interferón beta humano (interferón fibroblastoide, IFN-beta) glicosilado producido por las células de mamífero inmunomodulador C 913 H 1417 N 246 O 256 PS 7 [C 2 H 4 O] n 1211327-92-2

16. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 MedNet https://mednet-communities.net/inn/

17. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 INN for a global data hub Software Company Pharmaceutical Industry BPh IMGT SIB- University of Geneva DRAs ANSM WIPO FDA VIDAL USP National Authorities and various organizations INN

18. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 Use of stems To indicate chemical and /or pharmacological group relationship Published for 'established series of related compounds' INN and stems have protection within trade mark arena WHO publication "The use of stems in the selection of INN " Stem book 2013 Stem book pre-stems list  Names of "pharmacologically/chemically -related" substances have a common stem

19. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 How long…? 59 names 30% biologicals 12.5 months as an average Nearly 95% pub. after 1 or 2 rounds of discussion

20. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 Biologicals are more complex Interferon beta MW 19'000D Aspirin MW 180D

21. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 Naming Biosimilars? As Biosimilars are Biologicals, they should be named as Biologicals But if Biosimilars & Innovator biologicals are given the same INN, a mean to distinguish/ identify is needed (e.g trade name)

22. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 Some Problems with Biosimilars A regulatory route may or may not exist The same substance (product) may be viewed as biosimilar in some jurisdictions but not others Separate national solutions have been adopted No INN specific policy for biosimilars currently exists Some DRAs have requested WHO to develop an identification system applicable to biosimilars

23. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 INN a global name? epoetin alfa (2x) epoetin zeta epoetin kappa (generic recombination) epoetin alfa biosimilar 1 epoetin lambda

24. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 …… This is an issue that does need to be addressed globally, and soon The WHO INN Programme has a clear mandate The need for a harmonized (global) system is crucial

25. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 Biological Qualifier scheme All biological substances that are assigned INN should: 1.Be clearly identified 2.Have the INN of the reference product as the first part of the name 3.Have parallel nomenclature scheme (Biological Qualifier) that uniquely identifies the substance

26. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 Biological Qualifier Database INN Secretariat manages a secure database Applicant for a code submits online and follow progress DRAs: validate data and have unrestricted access to information in database Manufacturers/applicants/industry: what restrictions if any? ‘Public’: INN website lists codes and INN (and products?

27. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014

28. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 INN is simple "Simplicity is the ultimate sophistication" Leonardo Da Vinci

29. Dr R. Balocco Mattavelli, INN/TSN/RHT WHO Technical Briefing Seminar on Essential Medicines and Health Products Geneva, 3-7 November 2014 Thank you Grazie! Merci! Obrigado ! Gracias 谢谢！ありがう！ ARIGATOU ！ Danke! Dziękuję! Dank je / u! Mulţumesc! Teşekkür ederim! Tack!Tack så mycket Grazie! Kiitos! תודה לך ! Takk! ďakujem, ďakujem vám ; Hvala! شكراً ! shokran Ευχαριστώ! 감사합니다 Děkuji! Tak skal du have! Dankon! Hvala, Hvala lepa, Najlepša hvala Gràcies! Faleminderit Hvala! Ačiū, De’koju, Labai ačiū ขอบคุณ ; ขอบคุณมาก ( khàwp khun) ; (khàwp khun mâak) shukrīya ( بہت ) شكريه ( bahut) Cảm ơn cô ; Cảm ơn cô nhiều; Благодаря!Благодаря! Obrigado!” Gracias Þakka þér! baie dankie ; Takk fyri! Sipas dekem متشکرم ! Благодарам! Hvala Vam! V Təşəkkür Paldies!Pateicos! / Tencinu! Terima kasih Дуже дякую ;Дякую ; Спасибі! Баярлалаа ; Гялайлаа ; Танд их баярлалаа Terima kasih ধন্যবাদ ( dhonyobād) Salamat! Trugarez ! Mersi !Trugarez Danke!