On the regulatory approval pathway of biosimilar products

Pharmaceuticals

Volumn 5, Issue 4, 2012, Pages 353-368

  Wang, Jun ^a   Chow, Shein Chung ^a  

^a DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Biosimilarity; Biosimilars; EMA; FDA; Interchangeability; WHO

Indexed keywords

BIOLOGICAL PRODUCT;

BIOEQUIVALENCE; BIOLOGICAL ACTIVITY; CANADA; CLINICAL EVALUATION; DRUG APPROVAL; DRUG EFFICACY; DRUG MANUFACTURE; DRUG PURITY; DRUG QUALITY; DRUG RESEARCH; DRUG SAFETY; DRUG STABILITY; EUROPEAN MEDICINES AGENCY; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; JAPAN; KOREA; MEDICAL SOCIETY; ORGANIZATION; PHARMACODYNAMICS; PHARMACOKINETICS; PHYSICAL CHEMISTRY; POLITICAL PARTICIPATION; PRACTICE GUIDELINE; REVIEW; UNITED STATES; WORLD HEALTH ORGANIZATION;

EID: 84860285348     PISSN: None     EISSN: 14248247     Source Type: Journal    
DOI: 10.3390/ph5040353     Document Type: Review

References (31)

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