Innovation in biotechnology: Current and future states

Clinical Pharmacology and Therapeutics

Volumn 91, Issue 1, 2012, Pages 17-20

  Woollett, G R ^a  

^a LLP   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ENOXAPARIN; GENERIC DRUG; HUMAN GROWTH HORMONE; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

BIOTECHNOLOGY; DRUG MANUFACTURE; FOOD AND DRUG ADMINISTRATION; HUMAN; LICENCE; NONHUMAN; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; REVIEW;

ANIMALS; BIOLOGICAL AGENTS; BIOTECHNOLOGY; DIFFUSION OF INNOVATION; DRUG INDUSTRY; FORECASTING; HUMANS;

EID: 84055183559     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2011.219     Document Type: Review

References (14)

1. Title VII of Senate HR 3590 Patient Protection and Affordable Care Act. Biologics Price Competition and Innovation Act (BPCIA) 〈http://frwebgate. access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111-cong-bills&docid=f:h3590enr. txt.pdf〉 (enacted 23 March 2010).
2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline, comparability of biotechnological/biological products subject to changes in their manufacturing process 〈http://www.ich.org/fileadmin/ Public-Web-Site/ICH-Products/Guidelines/Quality/Q5E/Step4/Q5E-Guideline. pdf〉 (18 November 2004).
3. McCamish, M. Slide from presentation given for the Novartis Group, US Food and Drug Administration public meeting, "Approval Pathway for Biosimilar and Interchangeable Biological Products," 2-3 November 2010 〈http://www. regulations.gov/#!documentDetail;D=FDA-2010-N-0477-0064〉.
4. US Food and Drug Administration. Information on erythropoiesis- stimulating agents (ESA) epoetin alfa (marketed as Procrit, Epogen), darbepoetin alfa (marketed as Aranesp) 〈http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationfor PatientsandProviders/UCM109375〉.
5. Fradkin, J.E. et al. Creutzfeldt-Jakob disease in pituitary growth hormone recipients in the United States. JAMA 265, 880-884 (1991).
6. US Food and Drug Administration. Transmissible Spongiform Encephalopathies Advisory Committee 〈http://www.fda.gov/Advisory Committees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/ Transmissible SpongiformEncephalopathiesAdvisory Committee/default.htm〉.
7. US Food and Drug Administration. Advancing regulatory science for public health 〈http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/ RegulatoryScience/UCM228444.pdf〉 (October 2010).
8. US Food and Drug Administration. Critical Path Opportunities Report 〈http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/ CriticalPathInitiative/CriticalPathOpportunitiesReports/UCM077254.pdf〉 (March 2006).
9. US Food and Drug Administration. Critical Path Initiative updates 〈http://www.fda. gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/ default.htm〉.
10. PhRMA. 2011 profile: pharmaceutical industry 〈http://www.phrma.org/ sites/default/files/159/phrma-profile-2011-final.pdf〉 (April 2011).
11. US Food and Drug Administration. Presentations submitted to the FDA docket and presentations made at FDA public meeting, "Approval Pathway for Biosimilar and Interchangeable Biological Products," 2-3 November 2010 〈http://www.regulations. gov/#!searchResults;rpp=10;po=50;s=FDA-2010-N- 0477〉.
12. Usdin, S. Regulation: Myozyme's zig-zags. BioCentury 〈http://www. biocentury.com/biotech-pharma-news/coverstory/2008-10-27/regulationmyozymes-zig- zags-a1〉 (27 October 2008).
13. US Federal Trade Commission. The Federal Trade Commission's perspective on biosimilars. Current initiatives and longterm goals. Remarks of FTC Commissioner P.J. Harbour 〈http://www.ftc.gov/speeches/harbour/ 080923biosimilars.pdf〉 (23 September 2008).
14. US Federal Trade Commission. Emerging health care issues: follow-on biologic drug competition. FTC report on a workshop on biosimilars held fall 2008 〈http://www.ftc. gov/os/2009/06/P083901biologicsreport. pdf〉 (June 2009).