• Regulatory NewsRegulatory News

    PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances

    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is seeking comments on revisions to two parts of its GMP Guide (Annex 2A and Annex 2B) that deal with the manufacture of advanced therapy medicinal products (ATMPs) and biological medicinal substances and products for human use. PIC/S explains that draft Annex 2A accounts for international developments in the regulation of ATMPs, with particular attention to the European Commission guideline on GMP for ATMPs, whi...
  • Regulatory NewsRegulatory News

    UK’s NIBSC Updates on No-Deal Brexit Plans

    With less than a month remaining before the UK exits the EU, the UK’s National Institute for Biological Standards and Control (NIBSC) on Thursday provided an update in the event of a no-deal Brexit scenario.   In the update, the NIBSC, which produces and distributes a wide range of biological reference materials and functions as the UK’s official medicines control laboratory for biological products, says that while a Brexit deal “remains the Government’s top priority”...
  • Regulatory NewsRegulatory News

    UK Strategy for Pharmacopeial Quality Standards for Biologics: MHRA Discusses Comments

    Trade associations, manufacturers, academia and researchers have offered their opinions on the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) draft strategy for crafting pharmacopeial standards for biologics, according to a report issued Monday. In general, MHRA says the responses supported the value of standardization, and found that areas where standards could add value included providing guidance and ensuring consistency for product characterizat...
  • Regulatory NewsRegulatory News

    WHO Will Hold Off on Using Biological Qualifiers for Biosimilars

    No consensus has been reached on whether the World Health Organization (WHO) should continue with its biological qualifier proposal in assigning international nonproprietary names for biosimilars, and WHO says it "will not be proceeding with this at present," according to an October report. The US Biosimilars Council praised the WHO move , which follows the US Food and Drug Administration’s (FDA) use of a system in which biosimilar nonproprietary names come with a f...
  • 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 Warns Phototherapy Device Maker for Quality System Issues

    The US Food and Drug Administration (FDA) has warned device maker National Biological Corporation for quality systems issues following a two-week inspection of the firm's Beachwood, OH facility last March. The warning letter, dated 11 July 2017, details eight violations, including validation, recordkeeping and equipment calibration issues. FDA also says the company failed to notify it within 10 days of issuing a recall for one of its devices, and did not do so until the...
  • Feature ArticlesFeature Articles

    Biological Products and Biosimilars: Global Naming Debate

    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...
  • Regulatory NewsRegulatory News

    FDA Delays eCTD Requirements for Master Files

    The US Food and Drug Administration (FDA) is giving drugmakers an additional year before requiring master files to be submitted in electronic common technical document (eCTD) format. In a revised guidance released Friday, FDA says it is delaying the requirement for drug master files (DMF) and biological product files (BPF) to be submitted in eCTD format until 5 May 2018. Other documents, such as new drug applications (NDAs), abbreviated new drug applications (ANDAs) and...
  • Feature ArticlesFeature Articles

    Complex Medicinal Products - the Other 'Biosimilar'

    This article discusses Non-Biological Complex Drugs (NBCDs) and how FDA and other regulatory agencies review and approve generic forms of these products. Introduction With all the attention recently focused on biosimilars, it might be easy to overlook another group of generics, the complex medicinal products. This group is generally referred to as Non-Biological Complex Drugs (NBCD) and also may be referred to as complex medicinal products. Like biosimilars, NBCDs may...
  • 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

    FDA Issues Long-Awaited Biological Product Naming Guidance

    Today, the US Food and Drug Administration (FDA) released its long-awaited guidance establishing a naming convention for biologicals, including related and biosimilar products. Background With the passage of the Affordable Care Act in 2010, the US created a new pathway for biosimilar products to come to market, similar to the pathway in place for generic drugs. This pathway allows companies to get biosimilars to market more quickly and cheaply by relying on clinical ...