BPCI Act definition

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 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 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. *** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. CONFIDENTIAL TREATMENT REQUESTED
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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.

  • Specifically, the Biologics Price Competition and Innovation Act of 2009, or the BPCI Act, amended the Public Health Service Act to provide an abbreviated licensure pathway for biological products, or 351(k) application, shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.

  • 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.

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

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

  • 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.

  • Q.II.1. [This question and answer have been withdrawn and moved to FDA’s draft guidance for industry, New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).] Q.

  • FDA is also issuing a draft guidance document entitled New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).

  • Specifically, courts have now held that biosimilar applicants are not required to engage in the BPCI Act litigation scheme.


More Definitions of BPCI Act

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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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, Act 4 of 2013;

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

  • FMC Act means the Financial Markets Conduct Act 2013.

  • ACNC Act means the Australian Charities and Not-for-profits Commission Act 2012 (Cth).

  • PBR Act means the Plant Breeder’s Rights Xxx 0000 (Cth) as amended from time to time.

  • 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;

  • the 1998 Act (“Deddf 1998”) means the Teaching and Higher Education Act 1998;

  • OHS Act means the Occupational Health and Safety Act 2004;

  • 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 1991 Act means the Water Industry Act 1991(a);

  • Cannabis Act means An Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts, S.C. 2018, c. 16, as amended from time to time.

  • the 1988 Act means the Local Government Finance Act 1988.

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

  • the 1974 Act means the Health and Safety at Work etc. Act 1974;

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

  • Public Works Act means the Public Works Xxx 0000;

  • BC Act means the Securities Act (British Columbia);

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

  • 1990 Act means the Companies Act 1990.

  • EP Act means the Environmental Protection Xxx 0000;