Biosimilars: Regulatory status for approval;Biosimilares: situación regulatoria para su autorización

Farmacia Hospitalaria

Volumn 34, Issue SUPPL. 1, 2010, Pages 16-18

  Ambrosio, A Herrero ^a  

^a HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

Author keywords

Approval process; Biosimilars; EMEA

Indexed keywords

BIOSIMILAR DRUG; DRUG; UNCLASSIFIED DRUG;

BIOTECHNOLOGY; EUROPEAN MEDICINES EVALUATION AGENCY; HEALTH CARE ORGANIZATION; PATIENT SAFETY; PRACTICE GUIDELINE; SHORT SURVEY; WORLD HEALTH ORGANIZATION;

BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; EUROPEAN UNION; HUMANS; LEGISLATION, DRUG;

EID: 77957594771     PISSN: 11306343     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1130-6343(10)70004-0     Document Type: Article

References (5)

1. Guidelines on similar biological medicinal products. Disponible en: www.emea.europa.eu
2. European centralised procedure to approved medicines. Disponible en: www.ec.europa.eu/enterprise/pharmaceuticals/
3. Procedimientos de autorización de medicamentos. Disponible en: www.agemed.es
4. P. Declerck Biologicals in the era of biosimilars: implications for naming and prescribing EJHP Practice 13 2007 51 53
5. M. Timón, and S. Ruiz Bases regulatorias de los medicamentos de origen biotecnológico Revista Española de Economía de la Salud 61 2008 346 351