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:// medicines 803264051 0114-9954/17/1664-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 12 Aug 2017 No. 1664 Reactions Weekly Springer Journals

TGA seeks comments on naming of biological products

Reactions Weekly , Volume 1664 (1) – Aug 12, 2017
1 page

Loading next page...
1 Page
Springer International Publishing
Copyright © 2017 by Springer International Publishing AG
Medicine & Public Health; Drug Safety and Pharmacovigilance; Pharmacology/Toxicology
Publisher site
See Article on Publisher Site

There are no references for this article.

You’re reading a free preview. Subscribe to read the entire article.

DeepDyve is your
personal research library

It’s your single place to instantly
discover and read the research
that matters to you.

Enjoy affordable access to
over 12 million articles from more than
10,000 peer-reviewed journals.

All for just $49/month

Explore the DeepDyve Library

Unlimited reading

Read as many articles as you need. Full articles with original layout, charts and figures. Read online, from anywhere.

Stay up to date

Keep up with your field with Personalized Recommendations and Follow Journals to get automatic updates.

Organize your research

It’s easy to organize your research with our built-in tools.

Your journals are on DeepDyve

Read from thousands of the leading scholarly journals from SpringerNature, Elsevier, Wiley-Blackwell, Oxford University Press and more.

All the latest content is available, no embargo periods.

See the journals in your area

Monthly Plan

  • Read unlimited articles
  • Personalized recommendations
  • No expiration
  • Print 20 pages per month
  • 20% off on PDF purchases
  • Organize your research
  • Get updates on your journals and topic searches


Start Free Trial

14-day Free Trial

Best Deal — 39% off

Annual Plan

  • All the features of the Professional Plan, but for 39% off!
  • Billed annually
  • No expiration
  • For the normal price of 10 articles elsewhere, you get one full year of unlimited access to articles.



billed annually
Start Free Trial

14-day Free Trial