£58.10

Follow-On Biologics: Background & Issues (Biotechnology in Agriculture Industry and Medicine)

Biotechnology

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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 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).

Product Specifications

Format: hardcover
ASIN: 1611220769
Category: Books > Subjects > Science, Nature & Maths > Biological Sciences > Biotechnology
Domain: Amazon UK
Release Date: 01 March 2011
Listed Since: 05 November 2010

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Follow-On Biologics: Background & Issues (Biotechnology in Agriculture Industry and Medicine)

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