Developing the nation's biosimilars program

New England Journal of Medicine

Volumn 365, Issue 5, 2011, Pages 385-388

  Kozlowski, Steven ^a   Woodcock, Janet ^a   Midthun, Karen ^b   Sherman, Rachel Behrman ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b Center for Drug Evaluation and Research   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; BIOLOGICAL PRODUCT; BLOOD CLOTTING FACTOR; ENOXAPARIN; ENZYME; GENERIC DRUG; GROWTH FACTOR; INFLUENZA VACCINE; MONOCLONAL ANTIBODY; POLYCLONAL ANTIBODY; TOXIN;

ARTHRITIS; CELL THERAPY; DRUG APPROVAL; DRUG COST; DRUG MANUFACTURE; DRUG RESEARCH; EMPHYSEMA; FOOD AND DRUG ADMINISTRATION; GENETIC DISORDER; HEALTH PROGRAM; HEMOPHILIA; HEPATITIS C; HUMAN; IMMUNE DEFICIENCY; INFLUENZA; NEOPLASM; NONHUMAN; PRIORITY JOURNAL; SHORT SURVEY;

EID: 79961116944     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1107285     Document Type: Short Survey

References (5)

1. Biologics Price Competition and Innovation Act, 2009. (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ UCM216146.pdf.)
2. Emerging health care issues: follow-on biologic drug competition. Washington, DC: Federal Trade Commission, 2009. (http://www.ftc.gov/os/2009/06/ P083901biologicsreport.pdf.)
3. Woodcock J, Griffin J, Behrman R, et al. The FDA's assessment of follow-on protein products: a historical perspective. Nat Rev Drug Discov 2007;6:437-42. (Pubitemid 47078655)
4. Guideline on similar biological medicinal products. London: European Medicines Agency, 2005. (http://www.emea.europa.eu/pdfs/human/biosimilar/ 043704en.pdf.)
5. Draft: guideline on similar biological medicinal products containing monoclonal antibodies. London: European Medicines Agency, 2010. (http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2010/ 11/WC500099361.pdf.)