• Regulatory NewsRegulatory News

    FDA Reverses Course, Decides Not to Add Suffixes to Older Biologics’ Nonproprietary Names

    The US Food and Drug Administration (FDA) has decided not to go back and rename biologics’ nonproprietary names with nonsense suffixes, as it once said it would, raising questions about the confusion that will likely come from a subset of biologics’ and biosimilars’ names containing suffixes while another subset of biologics’ names will not contain suffixes. Since 2015, FDA has been adding the meaningless suffixes to biosimilars' nonproprietary names as part of an effor...
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    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...
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    Sanofi Raises Public Health Questions on Use of Nonsense Suffixes With New Vaccines

    A lot of ink has been spilled on the controversial random suffixes that the US Food and Drug Administration (FDA) is now tagging on the end of the nonproprietary names of biologics and biosimilars. Back in January 2017, FDA finalized a guidance document spelling out how this four-letter, FDA-designated meaningless suffix would be attached at the end of biologics’ and biosimilars’ nonproprietary names. Later in 2017 and 2018, companies began to realize FDA was only u...
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    FDA Withdraws Document Calling on Biosimilar Developers to Submit 10 Random Suffixes

    The US Food and Drug Administration (FDA) on Tuesday withdrew a document submitted to the Office of Management and Budget (OMB) that offered new details on how biosimilar developers would submit an ordered list of 10 random suffixes as part of the naming process for biologics and biosimilars. The document, first published 1 June , suggested a shift in FDA’s proposal on biologic and biosimilar naming as it altered the number of random suffixes proposed by developers (fro...
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    70 Groups Call on FDA to Revert Back to Meaningful Suffixes for Biosimilar Names

    The fight over how biosimilars should be named in the US isn’t over yet despite the US Food and Drug Administration’s (FDA) use of a non-proprietary name with a random suffix for the second approved biosimilar and plans to do the same for all future biosimilars. The group of nonprofits and other stakeholders, spearheaded by the Alliance for Safe Biologics, requested in a letter that FDA use meaningful suffixes for biosimilar non-proprietary names, such as the one used wi...