Regulatory aspects of biosimilars in Europe

Trends in Biotechnology

Volumn 27, Issue 7, 2009, Pages 385-387

  Zuñiga, Leyre ^a   Calvo, Begoña ^a  

^a UNIVERSITY OF THE BASQUE COUNTRY UPV EHU   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

BIOTECHNOLOGY;

BIOPHARMACEUTICALS; BIOSIMILARS; PATENT PROTECTION; PROTEIN CHARACTERIZATION; REGULATORY ASPECTS; STANDARDISED METHODS; STATE-OF-THE-ART TECHNOLOGY;

GENERIC DRUG; RECOMBINANT ERYTHROPOIETIN;

ARTICLE; BIOTECHNOLOGY; DRUG APPROVAL; DRUG EFFICACY; DRUG FORMULATION; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG QUALITY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; PATENT; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROTEIN ANALYSIS; STANDARDIZATION;

EID: 67549097000     PISSN: 01677799     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.tibtech.2009.03.005     Document Type: Note

References (14)

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