1. The current EU legal definition for generic products is found in Directive 2001/83/EC, Article 10(2)(b)
2. QRD general principles regarding the SmPC information for a generic/hybrid/biosimilar product, EMA/627621/2011, 3 May 2012
3. Compilation of individual product-specific guidance on demonstration of bioequivalence rev 2, EMA/CHMP/736403/2014 Rev 2, 7 July 2015
4. Chow S-C, Liu J-P (1992) Design and analysis of bioavailability and bioequivalence studies. Marcel Dekker Inc., New York
5. Guideline on the investigation of bioequivalence, CHMP/EWP/QWP/1401/98 Rev. 1,29 January 2010