1. European Commission . Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use, 2001.
2. United States Food and Drug Administration . Biosimilar and interchangeable products, 2018a. Available: www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm [Accessed 27 Jun 2019].
3. Worldwide experience with biosimilar development
4. European Medicines Agency . Biosimilar medicines: overview, 2018a. Available: www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines [Accessed 27 Jun 2019].
5. QuintilesIMS . 2017 IMS Biosimilar Report—The Impact of Biosimilar Competition in Europe, 2017. Available: http://ec.europa.eu/DocsRoom/documents/23102 [Accessed 27 Jun 2019].