Review on the worldwide regulatory framework for biosimilars focusing on the Mexican case as an emerging market in Latin America

Biotechnology Advances

Volumn 31, Issue 8, 2013, Pages 1333-1343

  Ibarra Cabrera, Ricardo ^a   Mena Pérez, Sandra Carolina ^b   Bondani Guasti, Augusto ^c   García Arrazola, Roeb ^b  

^a INBIOXICA   (Mexico)

^b SCHOOL OF ENGINEERING AND SCIENCES   (Mexico)

^c Pharmaceutical Industry   (Mexico)

Author keywords

Biopharmaceuticals; Biosimilars; Comparability; Evaluation guidelines; Mexican law; Regulatory framework

Indexed keywords

BIOPHARMACEUTICALS; BIOSIMILARS; COMPARABILITY; EVALUATION GUIDELINES; MEXICAN LAW; REGULATORY FRAMEWORKS;

COMMERCE; SYNTHESIS (CHEMICAL);

LAWS AND LEGISLATION;

BIOTECHNOLOGY; COMMERCIALIZATION; MARKET; PHARMACEUTICAL INDUSTRY; REGULATORY FRAMEWORK;

LATIN AMERICA;

BIOSIMILAR AGENT;

BIOLOGICS PRICE COMPETITION AND INNOVATION ACT; BIOPHARMACEUTICALS; BPCI ACT; COFEPRIS; COMISIÓN FEDERAL PARA LA PROTECCIÓN CONTRA RIESGOS SANITARIOS; COMPARABILITY; DRUG LEGISLATION; EVALUATION GUIDELINES; MEXICAN LAW; MEXICO; PAHO; PAN-AMERICAN HEALTH ORGANIZATION; REGULATORY FRAMEWORK; REVIEW; WORLD HEALTH ORGANIZATION;

BIOLOGICS PRICE COMPETITION AND INNOVATION ACT; BIOPHARMACEUTICALS; BIOSIMILARS; BPCI ACT; COFEPRIS; COMISIÓN FEDERAL PARA LA PROTECCIÓN CONTRA RIESGOS SANITARIOS; COMPARABILITY; EVALUATION GUIDELINES; MEXICAN LAW; PAHO; PAN-AMERICAN HEALTH ORGANIZATION; REGULATORY FRAMEWORK;

BIOSIMILAR PHARMACEUTICALS; LEGISLATION, DRUG; MEXICO; WORLD HEALTH ORGANIZATION;

EID: 84887860699     PISSN: 07349750     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.biotechadv.2013.05.005     Document Type: Review

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