"Follow-On Biologic Competition in the Biopharmaceutical Marketplace
Abstract
To describe the implications of a follow-on biologic approval process with focus on current stakeholders, implications of the status quo, and recommendations for future policy. Data Sources: A search using MEDLINE, International Pharmaceutical Abstracts, MedAdNews, FDC-Pink Sheets, and Google index directories was conducted with terms such as biologic. The biopharmaccutical industry emerged in 1982 with the development and market approval of recombinant human insulin (Humulin - Eli Lilly). Since that time, the industry has led major advancements in the management and prevention of previously untreatable disease through the design of innovative compounds. Two examples include' thrombolytics for the treatment of acute myocardial infarction and recombinant erythropoietin for management of anemia during end-stage renal disease. Both products yielded significant improvements over previously available therapeutic alternatives for each condition.
Document Details
- Document Type
- Technical Report
- Publication Date
- Mar 17, 2005
- Accession Number
- ADA431410
Entities
People
- Joshua W. Devine
Organizations
- Air Force Institute of Technology