BPCI Act definition

BPCI Act means the Biologics Price Competition and Innovation Act of 2009 within the Patient Protection and Affordable Care Act, as set forth in Section 351(k) of the PHS Act (42 U.S.C. 262), which was signed into law in the United States in March 2010, and as may be subsequently amended.
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BPCI Act means the Biologics Price Competition and Innovation Act of 2009, Public Law 111-148, title VII, subtitle A, as may be amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto).
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BPCI Act means the Biologics Price Competition and Innovation Act of 2009, and applicable regulations promulgated thereunder, as amended from time to time;
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Examples of BPCI Act in a sentence

  • However, the BPCI Act does provide a mechanism for a competitor to challenge the validity of an innovator’s patents as early as four years after initial marketing approval of the innovator biologic.

  • FDA believes that guidance for industry that provides answers to commonly asked questions regarding FDA’s interpretation of the BPCI Act will enhance transparency and facilitate the development and approval of biosimilar and interchangeable products.

  • BACKGROUND The BPCI Act was enacted as part of the Affordable Care Act on March 23, 2010.

  • The objectives of the BPCI Act are conceptually similar to those of the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub.

  • The BPCI Act amended the PHS Act and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product (see sections 7001 through 7003 of the ACA).

  • The BPCI Act amended the Public Health Service Act (PHS Act) and other statutes to create an abbreviated licensure pathway in section 351(k) of the PHS Act for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product (see sections 7001 through 7003 of the Patient Protection and Affordable Care Act (Pub.

  • The patent litigation scheme under the BPCI Act is complex, and interpretation of the BPCI Act is currently the subject of ongoing litigation.

  • FDA is also issuing a draft guidance document entitled New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).

  • BACKGROUND The BPCI Act The BPCI Act was enacted as part of the ACA on March 23, 2010.

  • The objectives of the BPCI Act are conceptually similar to those of the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (commonly referred to as the “Hatch-Waxman Amendments”), which established abbreviated pathways for the approval of drug products under section 505(b)(2) and 505(j) of the FD&C Act.


More Definitions of BPCI Act

BPCI Act means the Biologics Price Competition and Innovation Act of 2009 within the Patient Protection and Affordable Care Act, signed into law in March 2010, and as may be subsequently amended.
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BPCI Act means the Biologics Price Competition and Innovation Act.
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Related to BPCI Act

  • FOI Act means the Freedom of Information Xxx 0000 and any subordinate legislation made under this Act from time to time together with any guidance and/or codes of practice issued by the Information Commissioner in relation to such legislation;

  • POPI Act means the Protection of Personal Information Act 4 of 2013 as may be amended from time to time;

  • SEBI Act or “Act” means the Securities and Exchange Board of India Act, 1992;

  • S.A.F.E. Act means the secure and fair enforcement for mortgage licensing act of 2008, Title V of the housing and economic recovery act of 2008 ("HERA"), P.L. 110-289, effective July 30, 2008.

  • the 1992 Act means the Local Government Finance Act 1992;

  • WHS Act means the Work Health and Safety (National Uniform Legislation) Act 2011 (NT) and includes subordinate legislation made under that Act including regulations and approved codes of practice as well as any amendment, re-enactment or replacement of such Act ; and

  • 2012 Act means the Health and Social Care Act 2012;

  • CER Act means the Canadian Energy Regulator Act (Canada), and regulations thereunder, all as amended or replaced from time to time.

  • FAIS Act means the Financial Advisory and Intermediary Services Act, 2002 (Act No. 37 of 2002);

  • HITECH Act means the Health Information Technology for Economic and Clinical Health Act, TitleXIII, Subtitle D, Part 1 & 2 of the American Recovery and Reinvestment Act of 2009.

  • the 1981 Act which means the Compulsory Purchase (Vesting Declarations) Act 1981.

  • PPS Act means the Personal Property Securities Act 2009 (Cth).

  • the 1993 Act means the Pension Schemes Act 1993; “the 1995 Act” means the Pensions Act 1995;

  • 1990 Act means the Town and Country Planning Act 1990 (as amended);