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(INN) for Biological and Biotechnological Substances WHO/EMP/RHT/TSN/2016.1 International Nonproprietary Names (INN) for biological and biotechnological substances (a review) 2016 WHO/EMP/RHT/TSN/2016.1 International Nonproprietary Names (INN) for biological and biotechnological substances (a review) 2016 International Nonproprietary Names (INN) Programme Technologies Standards and Norms (TSN) Regulation of Medicines and other Health Technologies (RHT) Essential Medicines and Health Products (EMP) International Nonproprietary Names (INN) for biological and biotechnological substances (a review) FORMER DOCUMENT NUMBER: INN Working Document 05.179 © World Health Organization 2016 All rights reserved. Publications of the World Health Organization are available on the WHO website (www.who.int ) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected] ). Requests for permission to reproduce or translate WHO publications –whether for sale or for non-commercial distribution– should be addressed to WHO Press through the WHO website (www.who.int/about/licensing/copyright_form/en/index.html ). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Printed by the WHO Document Production Services, Geneva, Switzerland TABLE OF CONTENTS INTRODUCTION ................................................................................................................ 1 1. CURRENT STATUS OF EXISTING STEMS OR SYSTEMS FOR BIOLOGICAL AND BIOTECHNOLOGICAL SUBSTANCES [ 1- 7] ................................................... 3 1.1. Groups with respective stems ................................................................................. 3 1.2. Groups with INN schemes ..................................................................................... 4 1.3. Groups without respective stems / pre-stems .......................................................... 4 2. GENERAL POLICIES FOR BIOLOGICAL AND BIOTECHNOLOGICAL SUBSTANCES ............................................................................................................. 5 2.1. General policies for non-glycosylated compounds [ 8] ............................................ 5 2.2. General policies for glycosylated compounds [ 8] ................................................... 5 2.3. General policies for fusion proteins [ 4] .................................................................. 6 2.4. General policies for pegylated substances [ 22] ....................................................... 6 2.5. General policies for cell therapy products (CTP) .................................................... 6 2.6. General policies for gene therapy products (GTP)[ 2] ............................................. 8 2.7. General policies for monoclonal antibodies [ 1, 3, 11, 23] ...................................... 9 2.8. General policies for blood products [ 4] ................................................................ 11 2.9. General policies for immunoglobulins fractionated from plasma [ 9, 10] ............... 11 2.10. General policies for skin substitutes [ 4] ............................................................... 11 2.11. General policies for transgenic substances [ 4] (under discussion) ........................ 11 2.12. General policies for vaccines [ 4- 7] (under discussion) ......................................... 12 3. SUMMARY OF INN ASSIGNED TO BIOLOGICAL AND BIOTECHNOLOGICAL SUBSTANCES [ 1, 3, 7, 8, 13- 21] ............................................................................... 13 3.1. Antimicrobial, bactericidal permeability increasing polypeptides ......................... 13 3.2. Antisense oligonucleotides................................................................................... 13 3.3. Antithrombins ...................................................................................................... 13 3.4. Aptamers, classical and mirror ones ..................................................................... 13 3.5. Blood coagulation cascade inhibitors ................................................................... 14 3.6. Blood coagulation factors .................................................................................... 14 3.7. Cell therapy products (CTP) ................................................................................ 15 3.8. Colony stimulating factors (CSF) ......................................................................... 15 3.9. Enzymes .............................................................................................................. 16 3.10. Erythropoietin type blood factors ......................................................................... 19 3.11. Gene therapy products ......................................................................................... 19 3.12. Gonadotropin-releasing hormone (GnRH) inhibiting peptides .............................. 20 3.13. Growth factors and Tumour Necrosis Factors (TNF)............................................ 20 3.14. Growth hormone (GH) derivatives ....................................................................... 21 3.15. Growth hormone (GH) antagonists ...................................................................... 21 3.16. Heparin derivatives including low molecular mass heparins ................................. 21 3.17. Hirudin derivatives .............................................................................................. 21 3.18. Immunomodulators, both stimulant/suppressive and stimulant (under discussion) 22 3.19. Insulins ................................................................................................................ 22 3.20. Interferons ........................................................................................................... 23 3.21. Interleukin receptor antagonists ........................................................................... 23 3.22. Interleukin type substances .................................................................................. 24 3.23. Monoclonal antibodies ......................................................................................... 25 3.24. Oxytocin derivatives ............................................................................................ 30 i 3.25. Peptides and Glycopeptides ................................................................................. 30 3.26. Pituitary / Placental glycoprotein hormones ......................................................... 33 3.27. Pituitary hormone-release stimulating peptides .................................................... 33 3.28. Receptor molecules, native or modified (under discussion) .................................. 34 3.29. Small interfering RNA ......................................................................................... 35 3.30. Synthetic polypeptides with a corticotropin-like action ........................................ 35 3.31. Thrombomodulins ............................................................................................... 35 3.32. Toxins ................................................................................................................. 35 3.33. Vasoconstrictors, vasopressin derivatives ............................................................ 35 3.34. Vaccine-like substances (eg. peptide vaccines, recombinant vaccines) ................. 36 3.35. Various ................................................................................................................ 37 CURRENT CHALLENGES ............................................................................................... 41 REFERENCES ................................................................................................................... 43 ANNEX 1 . ................................................................................................................... 45 The list of INN for fusion proteins ................................................................................... 45 ANNEX 2 . ................................................................................................................... 55 List of INN for conjugated proteins ................................................................................. 55 ANNEX 3 . ..................................................................................................................
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