FDA Pleases No One With Final Guidance On Naming of Biologicals and Biosimilars.
نویسنده
چکیده
FDA pleases no one with final guidance on biological and biosimilar naming.
منابع مشابه
Biosimilar Naming Conventions: Pharmacist Perceptions and Impact on Confidence in Dispensing Biologics.
BACKGROUND The approval of the first biosimilar in the United States has placed increased pressure on the FDA to provide guidance on the naming convention that will be assigned to current and future biosimilars. The release of the FDA draft guidance on nonproprietary naming of biosimilars in August 2015 established a naming convention for all biologic products, including biosimilars. However, t...
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Biologics are the fastest growing segment of annual United States (US) drug expenditure. Biologics are complex proteins derived from living sources that are important therapy for a variety of diseases. The US is now poised to introduce biosimilars, which are copies of biologics that are not manufactured by the innovator company and are approved under an abbreviated regulatory process. Biosimila...
متن کاملBiosimilars: Implications for health-system pharmacists.
PURPOSE An update on scientific and regulatory challenges in the rapidly evolving field of biosimilar product development is presented. SUMMARY The U.S. market for biosimilar products (i.e., highly similar "follow-on" versions of approved biological drugs) is expected to expand with establishment of an expedited-approval pathway for biosimilars similar to that implemented in European Union co...
متن کاملRegulatory guidelines for biosimilars in Malaysia.
The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing pro...
متن کاملHealth Canada/BIOTECanada Summit on regulatory and clinical topics related to subsequent entry biologics (biosimilars), Ottawa, Canada, 14 May 2012.
In May 2012, Health Canada and other participants held a National Summit on Subsequent Entry Biologics (SEBs). Health Canada released a guidance document in March 2010 describing policy positions and data requirements for approval of SEBs. While Health Canada and health agencies in other regulatory jurisdictions are aligned on many scientific principles related to biosimilar drugs, Health Canad...
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ورودعنوان ژورنال:
- P & T : a peer-reviewed journal for formulary management
دوره 42 4 شماره
صفحات -
تاریخ انتشار 2017