Review of biosimilar regulatory guidelines and scientific principles:Experiences from Europe-an Medicines Agency (EMA) guidelines / 中国卫生政策研究
Chinese Journal of Health Policy
; (12): 21-26, 2014.
Article
in Zh
| WPRIM
| ID: wpr-459857
Responsible library:
WPRO
ABSTRACT
In this study, a literature review was adopted to specify terminology of biosimilars and demonstrate the basic characteristic of biologics and relevant research and development ( R&D) procedures. The regulatory frame-work of the European Medicines Agency ( EMA ) guidelines on biosimilars was introduced. Explicitly, regulatory guidelines and scientific principles, regarding biosimilarity, safety and immunogenicity, extrapolation, labels and names, data protection, were systematically introduced, as well as interchangeability and pharmacovigilance, respec-tively. The purpose of the study is to provide regulatory references for Chinese legislators and recommendations on the R&D of biosimilars in the biopharmaceutical industry.
Full text:
1
Index:
WPRIM
Type of study:
Guideline
Language:
Zh
Journal:
Chinese Journal of Health Policy
Year:
2014
Type:
Article