Biosimilars: Policy, clinical, and regulatory considerations

American Journal of Health-System Pharmacy

Volumn 65, Issue 14 SUPPL. 6, 2008, Pages

  Gottlieb, Scott ^a  

^a AMERICAN ENTERPRISE INSTITUTE   (United States)

Author keywords

Biologicals; Economics; Equivalency, therapeutic; European Union; Immunogenicity; Regulations; United States

Indexed keywords

BIOLOGICAL PRODUCT; BIOSIMILAR; GLYCOSYLATED PROTEIN; HUMAN GROWTH HORMONE; IMIGLUCERASE; INSULIN; INTERFERON; MONOCLONAL ANTIBODY; PROTEIN;

BIOEQUIVALENCE; CONFERENCE PAPER; COST CONTROL; DRUG EFFICACY; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG SAFETY; DRUG STRUCTURE; ECONOMIC ASPECT; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HEALTH CARE POLICY; IMMUNE RESPONSE; IMMUNOGENICITY; MEDICOLEGAL ASPECT; POLITICS; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROTEIN GLYCOSYLATION; PROTEIN STRUCTURE; UNITED STATES;

EID: 47349126691     PISSN: 10792082     EISSN: None     Source Type: Journal    
DOI: 10.2146/ajhp080210     Document Type: Conference Paper

References (13)

1. Frank RG. Regulation of follow-on biologies. N Engl J Med. 2007; 357:841-3.
2. 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.
3. Federal Food, Drug, and Cosmetic Act. New drugs. Sec. 505 [21 U.S.C. 355]. www.fda.gov/opacom/laws/fdcact/fdcact5a.htm#sec505 (accessed 2007 Dec 8).
4. Food and Drug Administration. Biological products regulated under section 351 of the Public Health Service Act; implementation of biologics license; elimination of establishment license and product license. www.fda.gov/cber/ rules/elapla.pdf (accessed 2007 Dec 8).
5. U.S. Food and Drug Administration. Omnitrope (somatropin [rDNA origin]) questions and answers. www.fda.gov/cder/drug/infopage/somatropin/qa.htm (accessed 2007 Dec 8).
6. Frank RG. The ongoing regulation of generic drugs. N Engl J Med. 2007; 357:1993-6.
7. Kuhlman M, Covic A. The protein science of biosimilars. Nephrol Dial Transplant. 2006; 21(Suppl5):v4-8.
8. Crommelin DJ, Storm G, Verrijk R et al. Shifting paradigms: biopharmaceuticals versus low molecular weight drugs. Int J Pharm. 2003; 266:3-16.
9. U.S. Food and Drug Administration. U.S. FDA considerations: discussion by national regulatory authorities with World Health Organization (WHO) on possible international non-proprietary name (INN) policies for biosimilars. September 1, 2006. www.fda.gov/cder/news/biosimilars.htm (accessed 2007 Dec 8).
10. European Medicines Agency Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. www.emea.europa.eu/pdfs/human/biosimilar/4934805en.pdf (accessed 2007 Dec 8).
11. Biotechnology Industry Organization (BIO). Follow on biologics (FOB). http://bio.org/healthcare/followonbkg/ (accessed 2008 May 30).
12. Wiecek A, Mikhail A. European regulatory guidelines for biosimilars. Nephrol Dial Transplant. 2006; 21(Suppl 5):v17-20.
13. Nowicki M. Basic facts about biosimilars. Kidney Blood Press Res. 2007; 30:267-72.