Article ID Journal Published Year Pages File Type
10852764 Biologicals 2011 4 Pages PDF
Abstract
In order to review the current situation in each country, a survey was planned in line with the implementation workshop of the guidelines in August 2010. The results show that the diversity of regulatory framework for licensing SBPs and the ambiguous use of the terms, 'similar' or 'generic', present considerable challenges for the future use of SBPs.
Keywords
Related Topics
Life Sciences Biochemistry, Genetics and Molecular Biology Biochemistry, Genetics and Molecular Biology (General)
Preview
Summary of the diverse situation of similar biotherapeutic products in the selected countries (August 2010)
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