Search Results for INN

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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

What's in a Name? Nonproprietary Naming of Biological Products By Rensi Sutaria, MS - Published 10 December 2015

This article discusses recently published FDA draft guidance on Nonproprietary Naming of Biological Products.

Categories: News, US, CBER, Biologics and biotechnology, Labeling, Regulatory strategy

Tags: Biological naming, Biosimilar naming, INN, International Nonproprietary Name

Senators Question FDA's Authority to Issue 'Placeholder' Name for First Biosimilar By Alexander Gaffney, RAC - Published 01 May 2015

When the US Food and Drug Administration (FDA) approved the US' first biosimilar product, Zarxio, in March 2015, it gave the drug a unique and temporary nonproprietary name. Now a group of US senators is questioning whether FDA had the legal authority to do so.

Categories: News, US, CDER, Biologics and biotechnology, Labeling

Tags: Biosimilar, Biosimilar Naming, Nonproprietary Name, INN, Senate, HELP Committee

FDA Says Nonproprietary Biologics Naming Policy Coming Later This Year Published 29 April 2015

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) plans to release five additional guidance documents by the end of 2015, including one on the nonproprietary names given to biological products, it announced Tuesday.

Categories: News, US, CDER, Biologics and biotechnology, Drugs

Tags: Guidance Agenda, Nonproprietary Name. INN

With US' First Biosimilar Approval Expected This Week, is FDA's Biosimilar Labeling Guidance Imminent? By Alexander Gaffney, RAC - Published 05 March 2015

The US Food and Drug Administration (FDA) quietly confirmed last week that it planned to release its long-sought biosimilars labeling guidance document sometime in 2015. But with the agency expected to approve the US' first biosimilar, Sandoz' Zarxio (filgrastim, EP2006), as early as tomorrow (6 March 2015), there's a good chance the biopharmaceutical industry won't have to wait long for the release of that guidance.

Categories: News, US, CDER, Biologics and biotechnology, Labeling

Tags: Biosimilar, Biosimilar Labeling Guidance, Guidance, Draft Guidance, INN

Australian Regulator Hits Restart on Plan to Name Biosimilars By Michael Mezher - Published 21 January 2015

Australia's medicines regulator, the Therapeutic Goods Administration (TGA), has announced it will no longer implement a planned update to the way in which it names biosimilar products following a proposal by the World Health Organization to change a naming standard on which Australia relied for its policy.

Categories: News, Oceania, TGA, WHO, Biologics and biotechnology, Labeling

Tags: Biosimilars, INN, WHO, Naming, World Health Organization, Australian Biological Name, ABN, International Nonproprietary Names

EMA Tightens Standards for Drug Naming Requests By Alexander Gaffney, RAC - Published 04 June 2014

European regulatory officials have tightened the standards for obtaining approval for a drug name, reducing the number of proposed names companies can put forth for consideration at any one time.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Labeling

Tags: Labeling, Invented Name, Proprietary Name, INN

EMA Releases New Guideline Meant to Clarify Process for Naming Drug Products By Alexander Gaffney, RF News Editor - Published 07 June 2013

Categories: EMA

Tags: INN, Drug Name, Naming, Name, Latest News, guideline, EU