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- Title
EMEA Guidelines on Biosimilars and Their Clinical Implications.
- Authors
Rossert, Jerome
- Abstract
The article summarizes the guidelines on recombinant human erythropoietin issued by the European Agency for the Evaluation of Medicinal Products and their implications. Various studies on recombinant human erythropoietin still need to be conducted, including human pharmacokinetic and pharmacodynamic and efficacy studies. Several questions are still pending regarding the guidelines, such as issues about naming, labeling, possibility of automatic substitution and traceability of biosimilars of epoietin.
- Subjects
RECOMBINANT erythropoietin; ERYTHROPOIETIN; RECOMBINANT blood proteins; PHARMACODYNAMICS; MEDICINE
- Publication
Kidney & Blood Pressure Research, 2007, Vol 30, Issue S1, p13
- ISSN
1420-4096
- Publication type
Article
- DOI
10.1159/000107276