1. Health C. 2010. Guidance for sponsors: Information and submission requirements for subsequent entry biologics (SEBs), 10-10569-330 ed. Ministry of Health, Canada.
2. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. 2005. Comparability of biotechnological/biological products subject to changes in their manufacturing process: Q5E. Federal Register. Silver Spring, Maryland: US FDA, p 37861.
3. ‘Biosimilar’ drugs poised to penetrate market;Ledford;Nature,2010
4. Comparative testing and pharmacovigilance of biosimilars;Locatelli;Nephrol Dial Transplant,2006
5. Follow-on biologics: Challenges of the “next generation”;Schellekens;Nephrol Dial Transplant,2005