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  • Regulatory NewsRegulatory News

    Canada Steers Away From Using Suffixes in Biologics' Names

    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...
  • Regulatory NewsRegulatory News

    FDA Begins Adding Suffixes to Newly Approved Biologics' Names

    • 17 November 2017
    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, ...
  • Regulatory NewsRegulatory News

    TGA Consults on Biological Naming

    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...
  • Regulatory NewsRegulatory News

    FDA Explains Why Newly Approved Biologic’s Name Lacks a Suffix

    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 ...
  • Regulatory NewsRegulatory News

    AbbVie, Novartis Criticize FDA’s Guidance on Nonproprietary Names for Biologics and Biosimilars

    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 ...
  • Feature ArticlesFeature Articles

    What's in a Name? Nonproprietary Naming of Biological Products

    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...
  • Regulatory NewsRegulatory News

    Industry, Patient Groups Weigh in on FDA's Biosimilar Naming Guidance

    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...
  • Regulatory NewsRegulatory News

    Senators Question FDA's Authority to Issue 'Placeholder' Name for First Biosimilar

    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...
  • Regulatory NewsRegulatory News

    FDA Says Nonproprietary Biologics Naming Policy Coming Later This Year

    • 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. 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...
  • Regulatory NewsRegulatory News

    Australian Regulator Hits Restart on Plan to Name Biosimilars

    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...