Follow-On Biologics

Name: Follow-On Biologics
Brand: Nova Science Publishers, Inc (US)
Price: 139.49 GBP
Availability: InStock

Background & Issues

Written by Daniel J Gutiérrez

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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).

ISBN-13: 9781611220766
Publisher: Nova Science Publishers Inc
Imprint: Nova Science Publishers, Inc (US)
Publication date: 14 June 2011
Format: Hardback
Pages: 148
Dimensions: 180 x 260 mm
Illustrations: tables
Language: English