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Follow-On Biologics: Background and Issues
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Editors: Daniel J. Gutiérrez
Book Description:
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 synthesized 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). (Imprint: Nova Biomedical Press)

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Table of Contents:

FDA Regulation of Follow-On Biologics;pp. 1-16
(Judith A. Johnson)

P.L. 111-148: Intellectual Property Provisions for Follow-On Biologics;pp. 17-23
(Wendy H. Schacht, John R. Thomas)

Follow-On Biologics: Intellectual Property and Innovation Issues;pp. 25-53
(Wendy H. Schacht, John R. Thomas)

Emerging Health Care Issues: Follow-On Biologic Drug Competition;pp. 55-140
(Federal Trade Commission Report)


      Biotechnology in Agriculture, Industry and Medicine
      Health Care Issues, Costs and Access
   Binding: Hardcover
   Pub. Date: 2011 1st quarter
   Pages: 7 x10 (NBC -G)148pp.
   ISBN: 978-1-61122-076-6
   Status: AV
Status Code Description
AN Announcing
FM Formatting
PP Page Proofs
FP Final Production
EP Editorial Production
PR At Prepress
AP At Press
AV Available
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Follow-On Biologics: Background and Issues