Biosimilar regulation in the EU

References

• Walsh G. Biopharmaceutical benchmarks 2014. Nat Biotechnol 2014;32:992-1000
   PubMed Web of Science ®Google Scholar
• PhRMA 2013. 2013 Report: Medicines in Development : BIOLOGICS. Available from: www.phrma.org/sites/default/files/pdf/biologicsoverview2013.pdf [Last accessed 9 June 2015]
   Google Scholar
• Anonymous 2014. Biologicals dominate Europe’s best sellers. www.gabionline.net. Posted 27/06/2014. Available from: http://gabionline.net/Reports/Biologicals-dominate-Europe-s-best-sellers [Last accessed 9 June 2015]
   Google Scholar
• Anonymous 2015. The global biologicals market. www.gabionline.net. Posted 13/06/2014. Available from: www.gabionline.net/Reports/The-global-biologicals-market [Last accessed 9 June 2015]
   Google Scholar
• EMA 2014a. The European regulatory system for medicines. A consistent approach to medicines regulation across the European Union (EMA/437313/2014). 2014. Available from: www.ema.europa.eu/docs/en_GB/document_library/Brochure/2014/08/WC500171674.pdf [Last accessed 9 June 2015]
   Google Scholar
• Schiestl M, Stangler T, Torella C, et al. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol 2011;29:310-12
   PubMed Web of Science ®Google Scholar
• ICH Q5E. ICH Harmonised Tripartite Guideline on Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process Q5E, 2004. Available from: www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf [Last accessed 9 June 2015]
   Google Scholar
• Lee JF, Litten JB, Gramp G. Comparability and biosimilarity: considerations for the health care provider. Current Med Res Opin 2012;28:1053-8
   PubMed Web of Science ®Google Scholar
• EMA, Guideline on similar biological medicinal products (CHMP/437/04 Rev 1). Available from: www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000408.jsp&mid=WC0b01ac058002958c#Overarchingbiosimilarguidelines [Last accessed 9 June 2015]
   Google Scholar
• EMA 1998. Concept paper: Development of a Committee for Proprietary Medicinal Products guideline on comparability of biotechnology-derived products. Available from: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003966.pdf [Last accessed 9 June 2015]
   Google Scholar
• Wiecek A, Mikhail A. European regulatory guidelines for biosimilars. Nephrol Dial Transplant 2006;21(Suppl 5):v17-20
   PubMed Web of Science ®Google Scholar
• Schellekens H, Moors E. Clinical comparability and European biosimilar regulations. Nat Biotechnol 2010;28:28-31
   PubMed Web of Science ®Google Scholar
• Commission Directive 2003/63/EC amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:159:0046:0094:en:PDF [Last accessed 9 June 2015]
   Google Scholar
• Tsiftsoglou AS, Ruiz S, Schneider CK. Development and regulation of biosimilars: current status and future challenges. BioDrugs 2013;27:203-11
   PubMed Web of Science ®Google Scholar
• EMA. Biological guidelines. Available from: www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000082.jsp&mid=WC0b01ac0580027547 [Last accessed 9 June 2015]
   Google Scholar
• EMA 2014. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1) (EMA/CHMP/BWP/247713/2012). Available from: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/06/WC500167838.pdf [Last accessed 9 June 2015]
   Google Scholar
• EMA. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CHMP/BMWP/42832/2005 Rev1). 2015. Available from: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf [Last accessed 9 June 2015]
   Google Scholar
• EMA. Similar-biological-medicine applications: questions and answers. Available from: www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000529.jsp&mid=WC0b01ac0580533e0b [Last accessed 9 June 2015]
   Google Scholar
• EMA. European Public Assessment Reports. Available from: www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124 [Last accessed 9 June 2015]
   Google Scholar
• Kurki P. Biosimilars for prescribers. Generics and Biosimilars Initiative Journal (GaBI Journal) 2015.4(1). Available from: http://gabi-journal.net/biosimilars-for-prescribers.html [Last accessed 9 June 2015]
   Google Scholar
• Beck A, Debaene F, Diemer H, et al. Cutting-edge mass spectrometry characterization of originator, biosimilar and biobetter antibodies. J Mass Spectrom 2015;50:285-97
   PubMed Web of Science ®Google Scholar
• Berkowitz SA, Engen JR, Mazzeo JR, Jones GB. Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nat Rev Drug Discov 2012;11:527-40
   PubMed Web of Science ®Google Scholar
• Kálmán-Szekeres Z, Olajos M, Ganzler K. Analytical aspects of biosimilarity issues of protein drugs. J Pharm Biomed Anal 2012;69:185-95
   PubMed Web of Science ®Google Scholar
• FDA 2015: Guidance for Industry. Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product. Available from: www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291134.pdf [Last accessed 9 June 2015]
   Google Scholar
• EMA 2013. European Public Assessment Report of Remsima. Available from: www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002576/human_med_001682.jsp&mid=WC0b01ac058001d124 [Last accessed 9 June 2015]
   Google Scholar
• Jung SK, Lee KH, Jeon JW, et al. Physicochemical characterization of Remsima. MAbs 2014;6:1163-77
   PubMed Web of Science ®Google Scholar
• Beck A, Reichert JM. Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry. MAbs 2013;5:621-3
   PubMed Web of Science ®Google Scholar
• van Aerts L, De Smet K, Reichmann G, et al. Biosimilars entering the clinic without animal studies – A paradigm shift in the European Union. mAbs 2014;6:1155-62
   PubMed Web of Science ®Google Scholar
• European Parliament and the Council. Directive 2010/63/EU on the protection of animals used for scientific purposes. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:276:0033:0079:en:PDF [Last accessed 9 June 2015]
   Google Scholar
• Brinks V. Immunogenicity of biosimilar monoclonal antibodies. GaBI Journal 2013;2:188-93
   Google Scholar
• Wolbink G, Aarden L, and Dijkmans B. Dealing with Immunogenicity of Biologicals: Assessment and Clinical Relevance. Curr Opin Rheumatol 2009;21:211-15
   PubMed Web of Science ®Google Scholar
• Schellekens H. The immunogenicity of therapeutic proteins. Discov Med 2010;49:560-4
   Google Scholar
• EMA 2008. Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic Proteins (EMEA/CHMP/BMWP/14327/2006). Available from: www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000408.jsp&mid=WC0b01ac058002958c#Otherguidelinesrelevantforbiosimilars [Last accessed 9 June 2015]
   Google Scholar
• EMA 2012. Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use (EMA/CHMP/BMWP/86289/2010). Available from: www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000408.jsp&mid=WC0b01ac058002958c#Otherguidelinesrelevantforbiosimilars [Last accessed 9 June 2015]
   Google Scholar
• United States Pharmacopeia 37. General Information/ Immunogenicity Assays (1106). Immunogenicity assays – design and validation of immunoassays to detect anti-drug antibodies. USP; Rockville, MD: 2013
   Google Scholar
• FDA: Guidance for Industry. Assay development for immunogenicity testing of protein therapeutics. Available from: www.fda.gov/downloads/Drugs/Guidances/UCM192750.pdf [Last accessed 9 June 2015]
   Google Scholar
• EMA 2007. Clinical investigation of the pharmacokinetics of therapeutic proteins (CPMP/EWP/89249/04). Available from: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003029.pdf [Last accessed 9 June 2015]
   Google Scholar
• Weise M, Kurki P, Wolff-Holz E, et al. Biosimilars: the science of extrapolation. Blood 2014;124:3191-6
   PubMed Web of Science ®Google Scholar
• Vermeer N, Straus S, Mantel-Teeuwisse A, et al. Traceability of biopharmaceuticals in spontaneous reporting systems: A cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and Eudravigilance databases. Drug Saf 2013;36:617-25
   PubMed Web of Science ®Google Scholar
• Endrenyi L, Chang C, Chow SC, Tothfalusi L. On the interchangeability of biological drug products. Statistics Med 2013;32:434-41
   PubMed Web of Science ®Google Scholar
• Ebbers H, Münzenberg M, Schellekens H. The safety of switching between therapeutic proteins. Expert Opin Biol Ther 2012;12:1473-85
   PubMed Web of Science ®Google Scholar
• Ebbers H, Crow S, Vulto A, Schellekens H. Interchangeability, immunogenicity and biosimilars. Nat Biotechnol 2012;30:1186-90
   PubMed Web of Science ®Google Scholar
• Weise M, Bielsky M-C, De Smet K, et al. Biosimilars – what clinicians should know. Blood 2012;120:5111-17
   PubMed Web of Science ®Google Scholar