Biosimilars clinical development program: Confirmatory clinical trials: A virtual/simulated case study comparing equivalence and non-inferiority approaches

Biologicals

Volumn 39, Issue 5, 2011, Pages 270-277

  Fletcher, Mark P ^a  

^a Applied Science International   (United States)

Author keywords

Biosimilar; Equivalence; Non inferiority; Reference biotherapeutic product; Similar biotherapeutic product

Indexed keywords

BIOLOGICAL PRODUCT; BIOSIMILAR; REFERENCE BIOTHERAPEUTIC PRODUCT; SIMILAR BIOTHERAPEUTIC PRODUCT; UNCLASSIFIED DRUG;

ARTICLE; CASE STUDY; CLINICAL DEVELOPMENT PLAN; CLINICAL EFFECTIVENESS; CLINICAL TRIAL (TOPIC); CONTROLLED CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; EQUIVALENCE DESIGN; NON INFERIORITY DESIGN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAMPLE SIZE; STATISTICAL MODEL; STUDY DESIGN; WORLD HEALTH ORGANIZATION;

CLINICAL TRIALS AS TOPIC; DRUG EVALUATION; GUIDELINES AS TOPIC; HUMANS; MODELS, THEORETICAL; RESEARCH DESIGN; WORLD HEALTH ORGANIZATION;

EID: 80053567603     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2011.06.004     Document Type: Article

References (4)

1. IFPMA points to consider in the drafting of WHO guidelines for biosimilar medicinal products, issued on November 22, 2007, http://www.ifpma.org/fileadmin/templates/ifpmaissues/pdfs/IFPMA_Pts_to_Consider_for_WHO_Biosimilar_GLs_Nov_2007.pdf.
2. Guidelines on evaluation of Similar Biotherapeutic Products (SBPs). EXPERT COMMITTEE ON BIOLOGICAL STANDARDIZATION Geneva, 19 to 23 October 2009. Adopted by the 60th meeting of the WHO Expert Committee on Biological Standardization; 19-23 October 2009.
3. Guideline On The Choice Of The Non-INFERIORITY MARGIN. EMEA/CPMP/EWP/2158/99 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE; 27 July 2005.
4. Guidance for Industry: Non-Inferiority Clinical Trials. DRAFT GUIDANCE. March 2010. Available at: Food and Drug Administration, Dockets home page, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM202140.pdf.