TGA seeks comments on naming of biological products

TGA seeks comments on naming of biological products Reactions 1664, p6 - 12 Aug 2017 TGA seeks comments on naming of biological products Australia’s Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposals regarding the nomenclature of biological medicines. "The active substances of biological medicines can be large complex molecules and the demonstration of similarity between a biosimilar and a reference medicine can be challenging", stated the TGA. The agency added that there are rising concerns that unknown adverse events (AEs) may arise from switching patients from an already registered biological medicine (i.e. innovator or reference product) to its corresponding biosimilar product. As such, it is important to have accurate information about which specific biological medicine was involved in the manifested AEs. While there is currently no internationally agreed convention for the naming of biosimilar products, Australia and Europe follow the same approach whereby the active ingredient of a biosimilar and its reference product are given the same INN. Recently, the US FDA announced that it will soon introduce a new requirement for the inclusion of a 4-letter suffix in the non-proprietary name of a biological medicine, to allow the reference products and corresponding biosimilar versions to be easily distinguishable. In light of these developments, the TGA wishes to consult on whether additional naming requirements are needed in Australia. Consultation documents are now available on the TGA’s website, and interested parties should respond by the close of business on 8 September 2017. Thereafter, the TGA will review all submissions received and results will be published on the agency’s website. * INN = International Non-proprietary Name. Therapeutic Goods Administration. Consultation: Nomenclature of Biological Medicines. Internet Document : 28 Jul 2017. Available from: URL: https:// www.tga.gov.au/consultation/consultation-nomenclature-biological- medicines 803264051 0114-9954/17/1664-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 12 Aug 2017 No. 1664 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Reactions Weekly Springer Journals

TGA seeks comments on naming of biological products

Reactions Weekly , Volume 1664 (1) – Aug 12, 2017
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Publisher
Springer International Publishing
Copyright
Copyright © 2017 by Springer International Publishing AG
Subject
Medicine & Public Health; Drug Safety and Pharmacovigilance; Pharmacology/Toxicology
ISSN
0114-9954
eISSN
1179-2051
D.O.I.
10.1007/s40278-017-34286-1
Publisher site
See Article on Publisher Site

Abstract

Reactions 1664, p6 - 12 Aug 2017 TGA seeks comments on naming of biological products Australia’s Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposals regarding the nomenclature of biological medicines. "The active substances of biological medicines can be large complex molecules and the demonstration of similarity between a biosimilar and a reference medicine can be challenging", stated the TGA. The agency added that there are rising concerns that unknown adverse events (AEs) may arise from switching patients from an already registered biological medicine (i.e. innovator or reference product) to its corresponding biosimilar product. As such, it is important to have accurate information about which specific biological medicine was involved in the manifested AEs. While there is currently no internationally agreed convention for the naming of biosimilar products, Australia and Europe follow the same approach whereby the active ingredient of a biosimilar and its reference product are given the same INN. Recently, the US FDA announced that it will soon introduce a new requirement for the inclusion of a 4-letter suffix in the non-proprietary name of a biological medicine, to allow the reference products and corresponding biosimilar versions to be easily distinguishable. In light of these developments, the TGA wishes to consult on whether additional naming requirements are needed in Australia. Consultation documents are now available on the TGA’s website, and interested parties should respond by the close of business on 8 September 2017. Thereafter, the TGA will review all submissions received and results will be published on the agency’s website. * INN = International Non-proprietary Name. Therapeutic Goods Administration. Consultation: Nomenclature of Biological Medicines. Internet Document : 28 Jul 2017. Available from: URL: https:// www.tga.gov.au/consultation/consultation-nomenclature-biological- medicines 803264051 0114-9954/17/1664-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 12 Aug 2017 No. 1664

Journal

Reactions WeeklySpringer Journals

Published: Aug 12, 2017

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