Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2500242 | Farmacia Hospitalaria | 2010 | 6 Pages |
Abstract
Authorisation according to the EMEA guidelines for biosimilars by centralized approval procedure, to demonstrate quality, efficacy and safety compared to the reference product Neupogen®. Comprehensive phase I and phase III clinical studies involving 880 subjects and patients have been completed (table 1).
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Authors
P. GarcÃa Alfonso,