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  • Regulatory NewsRegulatory News

    Mylan and Novartis to FDA: Where are the Suffixes?

    Mylan and Novartis are taking issue with the fact that the US Food and Drug Administration (FDA) has yet to begin issuing random suffixes for biologics’ names and so far has only used suffixes for biosimilars and a few recently approved biologics, according to comments released Wednesday. “The agency has not yet retroactively issued suffixes to any reference product for which there is a corresponding biosimilar. Given the agency's silence about this practice, there are ...
  • 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 ...
  • Regulatory NewsRegulatory News

    Non-Proprietary Naming of Biologics and Biosimilars: FDA Finalizes Guidance

    In a departure from the way the WHO and Europe name biologics, the US Food and Drug Administration (FDA) on Thursday finalized long-awaited guidance on how biosimilars and their biologic reference products’ names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name. The decision to finalize this guidance follows not only several tweaks (including one that has companies submit 10 suffixes to FDA for consideratio...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Releases New Guidance on Device Trial Inspections (24 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Releases Clutch of Draft Medical Device Clinical Trial Texts China Food and Drug Administration (CFDA) has released a handful of draft documents about clinical trials of medical devices. The documents, which detail the process for on-site inspections and the products that are exempt from studies, continue the ongoing overhaul of the regulation of medical devices in Chi...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA: Brand Name Confusion Led to Dozens of Medication Errors

    The US Food and Drug Administration (FDA) has issued a safety alert for two drugs, Brintellix and Brilinta, after receiving 50 reports of confusion between them caused by similarities in the drugs' names. Background When a new drug is submitted to FDA for review, the agency's Division of Medication Error Prevention conducts a review of the product's proposed brand name. FDA's main concern in reviewing the brand names of drugs is to ensure that a drug's brand name does n...
  • Regulatory NewsRegulatory News

    FDA Recommends Use of LOINC Data Standard

    The US Food and Drug Administration (FDA) is recommending the use of an existing data exchange standard for nearly all pharmaceutical and biological submissions. Background The agency, through its Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER), has decided to adopt the Logical Observation Identifiers Names and Codes (LOINC) as "part of a larger FDA effort to align the use of data standards for clinical research with ongoing ...
  • 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...
  • Feature ArticlesFeature Articles

    What’s In a Name? The Value of Pharmaceutical & Biologic Branding

    September 2014 marks 30 years since the Hatch-Waxman Amendments (Hatch-Waxman) to the Food, Drug, and Cosmetic Act (FD&C Act) introduced generics as we know them. Hatch-Waxman strove to offer consumers the benefits of “rapid availability of lower-priced generic versions of innovator drugs” 1 while preserving a meaningful period of market exclusivity for innovators to recoup their costs. In the process, however, Hatch-Waxman established conditions that fundamental...