Search Results for Biosimilar Naming

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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This article discusses recently published FDA draft guidance on Nonproprietary Naming of Biological Products.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 Stance on Naming Biosimilars Reportedly Finished, Awaiting Government Approval By Alexander Gaffney, RAC - Published 04 August 2014

Two of the Senate's highest-ranking legislators on healthcare issues are calling on the Department of Health and Human Services to finish its review of a guidance document on the naming of biosimilar products drafted by the US Food and Drug Administration (FDA).

Categories: News, US, CBER, CDER, Biologics and biotechnology, Labeling, Submission and registration

Tags: Biosimilar, Name, Naming, Senate, OMB, OIRA, Draft Guidance, Biosimilar Naming Guidance

Prominent Patient Group Comes out in Support of Distinguishable Names for Biosimilars By Alexander Gaffney, RAC - Published 05 June 2014

Ever since the US passed into law a new regulatory pathway in 2010 meant to permit the US Food and Drug Administration (FDA) to approve so-called "biosimilar products"—effectively generic biological products that differ slightly from the original product—one of the fiercest debates surrounding their use has also been one of the simplest: What do you call them?

Categories: News, US, Biologics and biotechnology, Labeling

Tags: NORD, Biosimilar, Biosimilar Naming, Unique Name