Concepedia

Biologic Exclusivity

Biologic Exclusivity is a form of regulatory data exclusivity that grants the holder of an approved biologic product exclusive rights to rely on the sponsor’s preclinical and clinical trial data for a defined period, thereby preventing regulatory agencies from accepting or approving generic or biosimilar applications for a specified duration following the original product’s approval.

11

Publications

508

Citations

37

Authors

24

Institutions

Publications per year

2017–2026

4

Parents

Publications

11

Where excludability matters: Material versus intellectual property in academic biomedical research

John P. Walsh, Wesley M. Cohen, Charlene Cho · Research Policy · 2007 · 217 citations

, , +16

Fresh from the biotech pipeline: fewer approvals, but biologics gain share

Melanie Senior · Nature Biotechnology · 2023 · 64 citations · Full text

, , +14

Market Exclusivity Length for Drugs with New Generic or Biosimilar Competition, 2012–2018

Benjamin N. Rome, ChangWon C. Lee, Aaron S. Kesselheim · Clinical Pharmacology & Therapeutics · 2020 · 47 citations

, , +14

The Science Behind Biosimilars

S. Louis Bridges, Douglas W. White, Angus B. Worthing et al. · Arthritis & Rheumatology · 2018 · 41 citations

, , +15

The Benefits From Giving Makers Of Conventional ‘Small Molecule’ Drugs Longer Exclusivity Over Clinical Trial Data

Dana P. Goldman, Darius Lakdawalla, Jesse D. Malkin et al. · Health Affairs · 2011 · 38 citations

, , +16

1–5 of 11

Authors

37

  1. AS
    Aaron S. Kesselheim

    Brigham and Women's Hospital, United States

    2 publications · 60 citations

    2

    h-index

  2. HG
    Henry G. Grabowski

    Duke University, United States

    1 publications · 11 citations

    1

    h-index

  3. DL
    Darius Lakdawalla

    University of Southern California, United States

    1 publications · 38 citations

    1

    h-index

  4. JK
    Jonathan Kay

    University of Massachusetts Chan Medical School, United States

    1 publications · 41 citations

    1

    h-index

  5. WM
    Wesley M. Cohen

    Duke University, United States

    1 publications · 217 citations

    1

    h-index

1–5 of 37

Institutions

24

  1. Harvard University

    Cambridge, United States

    2 h-index

    6 publications

    146 citations

  2. Brigham and Women's Hospital

    Boston, United States

    2 h-index

    7 publications

    193 citations

  3. Innovation Strategies (Spain)

    Palma, Spain

    1 h-index

    2 publications

    36 citations

  4. Precision Research (United States)

    Des Plaines, United States

    1 h-index

    1 publications

    38 citations

  5. University of Massachusetts Chan Medical School

    Worcester, United States

    1 h-index

    2 publications

    82 citations

  6. Southern Wesleyan University

    Central, United States

    1 h-index

    1 publications

    38 citations

  7. Clinical Insights

    Glen Burnie, United States

    1 h-index

    1 publications

    18 citations

  8. Gundersen Health System

    La Crosse, United States

    1 h-index

    1 publications

    41 citations

1–8 of 24

Venues

  1. Clinical Pharmacology & Therapeutics

    CPT · 2 publications · 60 citations

    2

    h-index

  2. Generics and Biosimilars Initiative Journal

    2 publications · 40 citations

    2

    h-index

  3. Nature Biotechnology

    1 publications · 64 citations

    1

    h-index

  4. Arthritis & Rheumatology

    1 publications · 41 citations

    1

    h-index

  5. PubMed

    Repository · 1 publications · 19 citations

    1

    h-index

1–5