Description

Book Synopsis
A biologic is a preparation, such as a drug or a vaccine, that is made from living organisms. A follow-on biologic, or biosimilar, is similar to the brand-name (innovator) product made by the pharmaceutical or biotechnology industry. In contrast to a biologic, most commonly used drugs are synthesised via a chemical process. Biologics often require special handling (such as refrigeration) and are usually administered to patients via injection or infused directly into the bloodstream. This book provides a brief introduction to the relevant law, the regulatory framework at the FDA, the scientific challenges for the FDA in considering the approval of follow-on biologics, and a brief description of the biologics provisions in the new healthcare reform bill signed into law under President Obama, entitled the Patient Protection and Affordable Care Act (PPACA).

Follow-On Biologics: Background & Issues

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    A Hardback by Daniel J Gutiérrez

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      Book details

      Publisher Nova Science Publishers Inc
      Published 14 June 2011
      ISBN-13 9781611220766
      978-1611220766
      ISBN-10 1611220769
      Also in:
      Technology, Engineering & Agriculture Biotechnology

      Description

      Book Synopsis
      A biologic is a preparation, such as a drug or a vaccine, that is made from living organisms. A follow-on biologic, or biosimilar, is similar to the brand-name (innovator) product made by the pharmaceutical or biotechnology industry. In contrast to a biologic, most commonly used drugs are synthesised via a chemical process. Biologics often require special handling (such as refrigeration) and are usually administered to patients via injection or infused directly into the bloodstream. This book provides a brief introduction to the relevant law, the regulatory framework at the FDA, the scientific challenges for the FDA in considering the approval of follow-on biologics, and a brief description of the biologics provisions in the new healthcare reform bill signed into law under President Obama, entitled the Patient Protection and Affordable Care Act (PPACA).

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