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Labeling of Biosimilars.
- Source :
- BioPharm International; Feb2015, Vol. 28 Issue 2, p12-48, 3p
- Publication Year :
- 2015
-
Abstract
- The article reports on the European Medicines Agency's (EMA) revised overarching guideline on principles of biosimilars approval and labelling to be implemented in April 2015. It mentions that the critics of the EMA's policy has been led by two trade bodies including the European Association of Bio-industries (EuropeBio) and the European Biopharmaceutical Enterprises (EBE). It highlights how the biosimilars' summary of product characteristics (SmPC) has been derived from reference product.
- Subjects :
- DRUG labeling laws
BIOLOGICALS -- Law & legislation
BIOLOGICAL products
Subjects
Details
- Language :
- English
- ISSN :
- 1542166X
- Volume :
- 28
- Issue :
- 2
- Database :
- Complementary Index
- Journal :
- BioPharm International
- Publication Type :
- Periodical
- Accession number :
- 101102412