Follow-On Biologics [electronic resource] : The Law and Intellectual Property Issues
- Corporate Author:
- Library of Congress. Congressional Research Service. Resources, Science, and Industry Division
- [Place of publication not identified] : [publisher not identified], 2011.
- Physical Description:
- 1 online resource (23 pages), digital, PDF file
- 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.
- Related Titles:
- ProQuest U.S. Congressional Research Digital Collection
- CRS Report.
Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Apr. 2014). Reuse except for individual research requires license from ProQuest, LLC.
- Technical Details:
- System requirements: PDF reader software.
View MARC record | catkey: 18406547