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3. World Health Organization (WHO) (2005) Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability – Draft Revision. Geneva, Switzerland. 4–39.
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5. US Food and Drug Administration (FDA) (2012) Draft Guidance on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD, U.S.A. 12–20.