Regulatory guideline for biosimilar products in Korea

Biologicals

Volumn 39, Issue 5, 2011, Pages 336-338

  Suh, Soo Kyung ^a   Park, Younjoo ^a  

^a Korea Food and Drug Administration   (South Korea)

Author keywords

Biological products; Biosimilar products; Guidelines; Korea; Regulation

Indexed keywords

BIOLOGICAL PRODUCT;

ARTICLE; CLINICAL EVALUATION; CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG INFORMATION; DRUG LEGISLATION; DRUG QUALITY; DRUG RESEARCH; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HEALTH CARE SYSTEM; KOREA; METHODOLOGY; OUTCOME ASSESSMENT; PATIENT SELECTION; PRACTICE GUIDELINE; PRIORITY JOURNAL; TOXICITY TESTING; WORLD HEALTH ORGANIZATION;

CLINICAL TRIALS, PHASE I AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DRUG EVALUATION; DRUG EVALUATION, PRECLINICAL; DRUG INDUSTRY; GUIDELINES AS TOPIC; HUMANS; KOREA; LEGISLATION, DRUG; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; WORLD HEALTH ORGANIZATION;

EID: 80053573008     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2011.06.008     Document Type: Article

References (6)

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3. The FDA's assessment of follow-on protein products: a historical perspective. Nature Review Drug Discovery 2007 Jun, 6(6):437-442.
4. Schellekens H. Follow-on biologics: challenges of the 'next generation'. Nephrology Dialysis Transplantation 2005, 20(Suppl. 4):iv31-iv36.
5. WHO guidelines on evaluation of similar biotherapeutic products (SBPs) October 2009, http://who.int/biologicals.
6. Korean guidelines on the evaluation of biosimilar products July 2009, http://www.kfda.go.kr/index.kfda?mid=226&pageNo=1&seq=388&cmd=v.