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Pharmaceuticals policy / Pharmaceutical industry / Biosimilar / Biotechnology / Drugs / Biologic / Drug Price Competition and Patent Term Restoration Act / Generic drug / Abbreviated New Drug Application / Pharmaceutical sciences / Pharmacology / Clinical research


Generic Versions of Biologics: The Problem and a Possible Solution By Paul F. Prestia This article is reprinted with permission from The Legal Intelligencer. © 2008 ALM Properties Inc. Further duplication without permis
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Document Date: 2013-03-31 19:00:47


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Company

ALM Properties Inc. / /

Continent

Europe / /

Country

United States / /

Event

FDA Phase / /

Facility

Court of Appeals for the Federal Circuit / /

IndustryTerm

biological tools / follow-on product / auxiliary new drug applications / biologic pharmaceuticals / follow-on biologic pharmaceuticals / pharmaceutical / intellectual property law / Present case law / patent law reform / manufacturing process / /

Organization

FDA / Congress / Court of Appeals / /

Person

Paul F. Prestia / /

Product

Europe / /

Technology

drug development / /

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