Evaluation of similar biotherapeutic products (SBPs): Scientific principles and their implementation

Biologicals

Volumn 39, Issue 5, 2011, Pages 256-261

  Knezevic, Ivana ^a  

^a WORLD HEALTH ORGANIZATION   (Switzerland)

Author keywords

Guidelines; Regulation of biologicals; Similar biotherapeutic products; WHO

Indexed keywords

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

ARTICLE; CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG EFFICACY; DRUG MANUFACTURE; DRUG QUALITY; DRUG SAFETY; DRUG SCREENING; DRUG SURVEILLANCE PROGRAM; LEGAL ASPECT; LICENSING; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; STANDARDIZATION; WORLD HEALTH ORGANIZATION;

DRUG INDUSTRY; GUIDELINES AS TOPIC; LEGISLATION, DRUG; PHARMACEUTICAL PREPARATIONS; WORLD HEALTH ORGANIZATION;

EID: 80053574167     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2011.08.008     Document Type: Article

References (5)

1. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs) 2010, World Health Organization. http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf.
2. Guidelines for assuring the quality of pharmaceutical and biological products prepared by recombinant DNA technology. WHO Expert Committee on Biological Standardization. Forty-first Report 1991, World Health Organization, Geneva, Annex 3 (WHO Technical Report Series No. 814).
3. Requirements for human interferons made by recombinant DNA techniques 1987, WHO TRS 771, Annex 7, adopted in. http://webitpreview.who.int/entity/biologicals/biotechnology/WHO_TRS_771_(part2)_A7.pdf.
4. Requirements for human interferons prepared from lymphoblastoid cells, WHO TRS 786, Annex 3, adopted in 1988. http://webitpreview.who.int/entity/biologicals/biotechnology/WHO_TRS_786_A3.pdf.
5. Guidelines for assuring the quality of monoclonal antibodies for use in humans, WHO 1991, TRS 822, Annex 3, adopted in, http://whqlibdoc.who.int/trs/WHO_TRS_822.pdf.