References
- Lee JF, Litten JB, Grampp G. Comparability and biosimilarity: considerations for the healthcare provider. Curr Med Res Opin 2012;28:1053–8
- Bennett CL, Chen B, Hermanson T, et al. Regulatory and clinical considerations for biosimilar oncology drugs. Lancet Oncol 2014;15:e594–605
- Schneider CK. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis 2013;72:315–18
- European Medicines Agency. Guideline on similar biological medicinal products, CHMP/437/04 Rev 1. Available at: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500176768 [Last accessed November 2015]
- European Medicines Agency. European Medicines Agency recommends approval of first two monoclonal antibody biosimilars. 2013. Available at: www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/06/WC500144941.pdf. [Last accessed January 2016]
- Beck A, Reichert JM. Approval of the first biosimilar antibodies in Europe. mAbs 2013;5:621–3
- Alten R, Cronstein BN. Clinical trial development for biosimilars. Semin Arthritis Rheum 2015;44:S2–8
- FDA Press Announcement/ucm436648, March 6, 2015. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm [Last accessed September 2015]
- International Conference on Harmonisation (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process Q5E. 2004. Available at: www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf [Last accessed July 2015]
- European Medicines Agency. European public assessment reports. Available at: www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d125 [Last accessed July 2015]
- World Health Organization. Guidelines on evaluation of similar biotherapeutic products (SBPs) 2009. Available at: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf [Last accessed January 2016]
- Schiestl M, Stangler T, Torella C, et al. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol 2011;29:310–12
- Zrubka Zs, Vezer B, Sebeszta M, Authorised manufacturing changes of therapeutic monoclonal antibodies in EPAR documents. Poster A8.31 at 23th European Workshop for Rheumatology Research, 5–7 March 2015, Budapest, Hungary