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. According to TGA, the need for a naming convention that can differentiate biologics from their biosimilar counterparts stems from concerns that adverse events could occur when switching patients between products, though the agency says there has been little evi...

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. Introduction Conventions and regulations for naming biosi...

This article discusses recently published FDA draft guidance on Nonproprietary Naming of Biological Products. What's in a name? Well, everything, since it provides a unique identity. A name may not be important to Romeo and Juliet, but it truly matters when it comes to regulation of biological products. On 27 August 2015, FDA published its long-awaited and much-anticipated draft guidance, Nonproprietary Naming of Biological Products . 1 The draft guidance describes F...

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. Background Zarxio is the first drug to be approved under the 351(k) pathway created in 2010 under the Patient Protection and Affordable Care Act . The drug, which is manufactured by Sandoz, is intended to be bio...

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. Background The 28 April 2015 announcement came in the form of an updated list of guidance documents, known as CDER's "Guidance Agenda." The list is an accounting of all guidance documents the agency plans to release—e...

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. Background At issue is the nomenclature syst...

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. Background Under TGA's original proposal , biosimilars would have been referred to using their Australian Biological Name (ABN) followed by the prefix “sim(a),” whe...

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. The change, contained in a revised guideline, on the Acceptability of Names for Human Medicinal Products Processed Through the Centralised Procedure , reduces the number of proposed names that may be sent to the European Medicines Agency (EMA) to two invented names. At...

Around the globe, healthcare product regulators have expressed an interest in-and occasionally concern with-naming conventions for brand-name pharmaceutical products. EU regulators are no exception to this rule, and announced this week that they have issued new revisions to a guideline regarding the acceptability of names for human medicines. Background While many consumers might consider branded pharmaceutical names a marketing tool-which they undoubtedly are-regulator...