1. EMA: Medicines | European Medicines Agency (europa.eu). [Internet]. Amsterdam. [cited 2023 Nov 15]. Available from: https://www. ema.europa.eu/en/medicines searched <“monoclonal” between 2013 November 14 and 2023 November 14 excluded “biosimilars” + “withdrawn products”>
2. ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Harmonised guideline. Organisation of the common technical document for the registration of pharmaceuticals for human use (M4). Current Step 4 Version. 2016 Jun 15 [cited 2023 Nov 15].
3. CHMP: Committee for Medicinal Products for Human Use (CHMP) Guideline on non-clinical and clinical development of similar biological medicinal products containing low molecular-weight-heparins [internet]. 2016 Nov 10 [cited 2023 Nov 15]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-non-clinical-and-clinical-development-similar-biological-medicinal-products-containing-low-molecular-weight-heparins-revision-1_en.pdf
4. FDA: “deemed to be a license” provision of the BPCI Act. 2020 Apr 4 [cited 2023 Nov 15]. Available from: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/deemed-be-license-provision-bpci-act#:~:text=The%20Biologics%20Price%20Competition%20and biologics%20license%20application%20(BLA)%20under
5. CHMP: Assessment report: Remsima® (INN: infliximab). Procedure No. EMEA/H/C/002576/000. 2013 June 27 [cited 2024 Feb 12]. Available at: https://www.ema.europa.eu/en/documents/assessment-report/remsima-epar-public-assessment-report_en.pdf