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Year: 2018 Publisher: [Washington, D.C.] : Congressional Research Service,
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Pharmaceutical policy --- Drugs --- Pharmaceutical industry --- Drug development --- Patent laws and legislation --- Patents. --- United States.
Year: 2019 Publisher: [Washington, D.C.] : Congressional Research Service,
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Pharmaceutical policy --- Drugs --- Law and legislation --- United States.
ISBN: 0314147519 Year: 2004 Publisher: Saint Paul Thomson West
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ISBN: 9780314147523 Year: 2021 Publisher: St. Paul West-Academic
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ISBN: 9780314276681 Year: 2019 Publisher: St. Paul West Academic Publishing
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Year: 2018 Publisher: [Washington, D.C.] : Congressional Research Service,
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Year: 2018 Publisher: [Washington, D.C.] : Congressional Research Service,
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ISBN: 9780314147509 Year: 2010 Publisher: Saint Paul Thomson West
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Year: 2019 Publisher: [Washington, D.C.] : Congressional Research Service,
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Drugs --- Purchasing
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Year: 2014 Publisher: Washington, District of Columbia : Congressional Research Service,
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Reviews intellectual property and innovations issues within context of the Biologics Price Competition and Innovation Act (BPCIA) of 2009, which established expedited licensor pathway for competing versions of previously marketed biologics, created FDA-administered periods of data protection and marketing exclusivity for certain brand-name drugs and follow-on products, and provided a patent dispute resolution procedure for use by brand-name and follow-on biologic manufacturers. Provides introduction to biologics industry, which includes biotechnology and biopharmaceutical industries; reviews regulatory and intellectual property provisions of BPCIA; and considers potential market for biosimilars and possible responses that may arise in wake of this legislation.
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