ACT;
DRUG EFFICACY;
DRUG NOMENCLATURE;
FOOD AND DRUG ADMINISTRATION;
HEALTH CARE POLICY;
HUMAN;
IMMUNOGENICITY;
LAW;
OVERALL SURVIVAL;
PHASE 3 CLINICAL TRIAL (TOPIC);
PRACTICE GUIDELINE;
PRIORITY JOURNAL;
PROTEIN PROCESSING;
PUBLICATION;
REVIEW;
Behrman R, FDA news release [online]. Available from URL: http://www. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm291232.htm [Accessed 2012 Feb 9]
U.S. Department of Health and Human Services Food and Drug Administration [online]. Available from URL: [Accessed Feb 9]
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US National Institute of Health. NCT01473420 [online].Available fromURL:Accessed Feb 14]
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US National Institute of Health. PIONEER) [online]. Available from URL:[Accessed Jan 24]
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Loeb J. FDA action on Teva's neutroval BLA causes some to question biosimilar route [online]. Available from URL: http://www.biolawgics.com/ fdaapproval/ fda-action-on-tevas-neutroval-bla-causes-some-to-question-bio similar-route. [Accessed 2011 Mar 29]
FDA Draft Guidance for Industry.online]. Available from URL: [Accessed Feb 20 ]
FDA Draft Guidance for Industry. Non inferiority clinical trials [online]. Available from URL: http://www.fda.gov/downloads/Drugs/GuidanceCom plianceRegulatoryInformation/Guidances/UCM202140.pdf [Accessed 2010 Feb 20 ]