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

  • 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.

  • On March 23, 2010, the BPCI Act was enacted as part of the Patient Protection and Affordable Care Act (Public Law 111-148).

  • The BPCI Act amended the 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 BPCI Act).

  • 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 [This question and answer have been withdrawn and moved to FDA’s draft guidance for industry, New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).]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 proposing to amend its regulations to implement certain aspects of the BPCI Act.

  • The BPCI Act requires that marketing applications for “biological products” needs to be submitted as a biologic licence application, or BLA.

  • Section 351(k) of the PHS Act (42U.S.C. 262(k)), added by the BPCI Act, sets forth the requirements for a biosimilar product application.

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

  • Formalizing these interpretations would reduce regulatory uncertainty introduced by the BPCI Act.


More Definitions of BPCI Act

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 Act 2000 and any subordinate legislation made under that Act or any code issued pursuant to sections 45 or 46 of that Act or any guidance issued by the Information Commissioner;

  • POPI Act means the Protection of Personal Information Act, 4 of 2013;

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

  • FW Act means the Fair Work Act 2009, as amended from time to time.

  • 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.

  • FDI Act means the Federal Deposit Insurance Act, as amended or recodified.

  • 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 Act 2011 (Qld) or the Work Health and Safety (National Uniform Legislation) Act 2012 (NT), where applicable. WHS EPH means Workplace Health and Safety Entry Permit Holders under the WHS Act. Workplace Impairment Policy and Procedures means the Workplace Impairment Policy and Procedures found in APPENDIX 4.

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

  • 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 Town and Country Planning Act 1990;