1. US FDA. Information on Biosimilars. 2017. https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ . Accessed 01 Sept 2017.
2. European Medicines Agency. Questions and answers on biosimilar medicines: EMA2012 27 Sept 2012.
3. US Public Health Service Act. Section 7002(b)(3) of the Affordable Care Act, adding section 351(i)(2).
4. Comment from Biosimilars Medicines Group, A Medicines for Europe sector group. Docket submission and presentaton to the Oncologic Drugs Advisory Committee meeting of 13 July 2017. https://www.regulations.gov/document?D=FDA-2017-N-2732-0006 . Accesed 21 Nov 2017.
5. ICH Harmonised Tripartite Quality Guideline 5E (Q5E). Comparability of biotechnological/biological products subject to changes in their manufacturing process. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf ; and http://www.ich.org/products/guidelines/quality/quality-single/article/comparabilityof-biotechnologicalbiological . Accessed 30 Aug 2017.