Search Results for Biological Qualifier

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WHO Will Hold Off on Using Biological Qualifiers for Biosimilars By Zachary Brennan - Published 19 October 2017

No consensus has been reached on whether the World Health Organization (WHO) should continue with its biological qualifier proposal in assigning international nonproprietary names for biosimilars, and WHO says it "will not be proceeding with this at present," according to an October report.

Categories: News, Asia, Europe, US, WHO, Biologics and biotechnology, Labeling, Postmarket surveillance

Tags: biological qualifier, biosimilar naming

TGA Consults on Biological Naming By Michael Mezher - Published 28 July 2017

Australia's Therapeutic Goods Administration (TGA) on Friday launched a public consultation to gather feedback on proposals for potential biological naming systems, including options for EU- or US-aligned systems.

Categories: News, Oceania, TGA, Biologics and biotechnology

Tags: Biological Naming, Biosimilars, INN, Nonproprietary Name, Suffix, Biological Qualifier

Biological Products and Biosimilars: Global Naming Debate By Pallavi Trivedi - Published 27 June 2017

This article presents the contrasting views and continuing debate among health authorities in Australia, Canada, Europe, Japan and the US as well as industry experts regarding conventions for naming biological products and biosimilars. It discusses the World Health Organization's (WHO's) proposal for naming and the importance of a clear distinction between the drugs to avoid confusion and ensure patient safety.

Categories: News, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, PMDA, TGA, WHO, Biologics and biotechnology, Submission and registration

Tags: Biosimilars, Biosimilar Naming, Biological Qualifier, INN

Industry, Patient Groups Weigh in on FDA's Biosimilar Naming Guidance By Michael Mezher - Published 29 October 2015

Industry is calling on the US Food and Drug Administration (FDA) to use to use "meaningful" and "distinguishable" suffixes linked to a biosimilar license holder's name, according to comments on the proposed naming system.

Categories: News, US, FDA, FTC, Biologics and biotechnology, Postmarket surveillance, Regulatory strategy, Submission and registration

Tags: Biological naming, Nonproprietary Naming of Biological Products, Biological Qualifier, Biosimilar

FDA Issues Long-Awaited Biological Product Naming Guidance By Michael Mezher - Published 27 August 2015

Today, the US Food and Drug Administration (FDA) released its long-awaited guidance establishing a naming convention for biologicals, including related and biosimilar products.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Labeling, Postmarket surveillance, Submission and registration

Tags: Biosimilars, related biological products, naming convention, biological qualifier, suffix