Canada has decided to not use suffixes in the non-proprietary names of biologics or biosimilars, making the US the only country in the world to use such suffixes. “Following internal and external stakeholder consultations and analysis of related issues, Health Canada has decided that biologic drugs, including biosimilars, will be identified by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix,” a notice to stake...

The US Food and Drug Administration (FDA) this week began adding four-letter meaningless suffixes at the end of newly approved biologics' nonproprietary names, signaling a shift in policy from only adding the suffixes to biosimilars' nonproprietary names since 2015. The first additions of the meaningless suffixes came for Thursday's approval of Roche's Hemlibra (emicizumab-kxwh), one of the first new medicines in nearly two decades to treat people with hemophilia A, ...

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...

The US Food and Drug Administration (FDA) approved a new biologic this week, but its name did not adhere to recently finalized guidance calling for all new and previously approved biologics and biosimilars to have a four-letter random suffix attached to their nonproprietary names. “This week’s biologic, [ Valeant Pharmaceuticals ’] Siliq (brodalumab) was licensed under section 351(a) of the Public Health Service Act , and thus is within the scope of our recently ...

Biopharmaceutical companies Novartis and AbbVie are taking issue with the US Food and Drug Administration’s (FDA) burdensome plan to require retroactive changes to the nonproprietary names of existing biologics and biosimilars, according to comments sent to the agency this week. “Retroactive application of the naming policy not only is unnecessary ‘for the proper performance of the functions of the agency,’ but it also is likely to undermine FDA’s objectives in adopting ...

The US Food and Drug Administration (FDA) on Monday approved a brand name change for Takeda’s antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from confusion with AstraZeneca’s blood-thinning medicine Brilinta (ticagrelor). The new brand name of Brintellix will be Trintellix, and the tablets will look nearly identical and are expected to be available in June, FDA said. “No other changes will be made to the la...

The final guidance from the US Food and Drug Administration is part of a host of proprietary name evaluation measures from the reauthorization of the Prescription Drug User Fee Act and aims to help reduce medication errors. Although prescription drug names can sound funny or awkward, health care providers often rely on the proprietary name as the critical identifier of the appropriate therapy in a market of tens of thousands of products. Product names that look or soun...

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...

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. In total, FDA received 178 comments on its draft guidance, known as Nonproprietary Naming of Biological Products , including clear calls for changes to FDA's proposal. Background In August, FDA released the guidance, which proposed a naming conventi...

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...

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...