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Editorial

Approval of the first biosimilar antibodies in Europe

A major landmark for the biopharmaceutical industry

&
Pages 621-623 | Received 23 Jul 2013, Accepted 23 Jul 2013, Published online: 24 Jul 2013

References

  • Beck A, Carter PJ, Gerber HP, Lugovskoy AA, Wurch T, Junutula JR, et al. 8th Annual European Antibody Congress 2012: November 27-28, 2012, Geneva, Switzerland. MAbs 2013; 5:339 - 57; http://dx.doi.org/10.4161/mabs.24105
  • Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Narayanan G, et al. Biosimilars-why terminology matters. Nat Biotechnol 2011; 29:690 - 3; http://dx.doi.org/10.1038/nbt.1936; PMID: 21822237
  • Visser J, Feuerstein I, Stangler T, Schmiederer T, Fritsch C, Schiestl M. Physicochemical and functional comparability between the proposed biosimilar rituximab GP2013 and originator rituximab. BioDrugs 2013; http://dx.doi.org/10.1007/s40259-013-0036-3; PMID: 23649935
  • Beck A, Wurch T, Bailly C, Corvaia N. Strategies and challenges for the next generation of therapeutic antibodies. Nat Rev Immunol 2010; 10:345 - 52; http://dx.doi.org/10.1038/nri2747; PMID: 20414207
  • Beck A. Biosimilar, biobetter and next generation therapeutic antibodies. MAbs 2011; 3:107 - 10; http://dx.doi.org/10.4161/mabs.3.2.14785; PMID: 21285536
  • Beck A. Glycosylation Engineering of Biopharmaceuticals. Methods in Molecular Biology, Vol. 988. Beck, Alain (Ed.) Springer, 2013.
  • Beck A, Sanglier-Cianférani S, Van Dorsselaer A. Biosimilar, biobetter, and next generation antibody characterization by mass spectrometry. Anal Chem 2012; 84:4637 - 46; http://dx.doi.org/10.1021/ac3002885; PMID: 22510259
  • Schneider CK, Kalinke U. Toward biosimilar monoclonal antibodies. Nat Biotechnol 2008; 26:985 - 90; http://dx.doi.org/10.1038/nbt0908-985; PMID: 18779806
  • Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Giezen TJ, et al. Biosimilars: what clinicians should know. Blood 2012; 120:5111 - 7; http://dx.doi.org/10.1182/blood-2012-04-425744; PMID: 23093622
  • Reichert JM, Beck A, Iyer H. European Medicines Agency workshop on biosimilar monoclonal antibodies: July 2, 2009, London, UK. MAbs 2009; 1:394 - 416; http://dx.doi.org/10.4161/mabs.1.5.9630; PMID: 20065643
  • Beck A, Reichert JM. Therapeutic Fc-fusion proteins and peptides as successful alternatives to antibodies. MAbs 2011; 3:415 - 6; http://dx.doi.org/10.4161/mabs.3.5.17334; PMID: 21785279
  • Schneider CK, Vleminckx C, Gravanis I, Ehmann F, Trouvin JH, Weise M, et al. Setting the stage for biosimilar monoclonal antibodies. Nat Biotechnol 2012; 30:1179 - 85; http://dx.doi.org/10.1038/nbt.2447; PMID: 23222783
  • Scientific considerations in demonstrating biosimilarity to a reference product [Internet]. Washington (DC); US Food and Drug Administration: c2012 [cited 23 July 2013]. Available from: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf
  • Quality considerations in demonstrating biosimilarity to a reference protein product [Internet]. Washington (DC); US Food and Drug Administration: c2012. [cited 23 July 2013]. Available from: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf
  • Kálmán-Szekeres Z, Olajos M, Ganzler K. Analytical aspects of biosimilarity issues of protein drugs. J Pharm Biomed Anal 2012; 69:185 - 95; http://dx.doi.org/10.1016/j.jpba.2012.04.037; PMID: 22633839
  • 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; http://dx.doi.org/10.1038/nrd3746; PMID: 22743980
  • Beck A, Wagner-Rousset E, Ayoub D, Van Dorsselaer A, Sanglier-Cianférani S. Characterization of therapeutic antibodies and related products. Anal Chem 2013; 85:715 - 36; http://dx.doi.org/10.1021/ac3032355; PMID: 23134362
  • Xie H, Chakraborty A, Ahn J, Yu YQ, Dakshinamoorthy DP, Gilar M, et al. Rapid comparison of a candidate biosimilar to an innovator monoclonal antibody with advanced liquid chromatography and mass spectrometry technologies. MAbs 2010; 2:379 - 94; PMID: 20458189
  • Gahoual R, Burr A, Busnel JM, Kuhn L, Hammann P, Beck A, et al. Rapid and multi-level characterization of trastuzumab using sheathless capillary electrophoresis-tandem mass spectrometry. MAbs 2013; 5:479 - 90; http://dx.doi.org/10.4161/mabs.23995; PMID: 23563524
  • Chen SL, Wu SL, Huang LJ, Huang JB, Chen SH. A global comparability approach for biosimilar monoclonal antibodies using LC-tandem MS based proteomics. J Pharm Biomed Anal 2013; 80:126 - 35; http://dx.doi.org/10.1016/j.jpba.2013.02.040; PMID: 23563225
  • Tan Q, Guo Q, Fang C, Wang C, Li B, Wang H, et al. Characterization and comparison of commercially available TNF receptor 2-Fc fusion protein products. MAbs 2012; 4:761 - 74; http://dx.doi.org/10.4161/mabs.22276; PMID: 23032066
  • Beck A, Diemer H, Ayoub D, Debaene F, Wagner-Rousset E, Carapito C, et al. Analytical characterization of biosimilar antibodies and Fc-fusion proteins. Trends Analyt Chem 2013; 48:81 - 95; http://dx.doi.org/10.1016/j.trac.2013.02.014
  • Ayoub D, Jabs W, Resemann A, Evers W, Evans C, Main L, et al. Correct primary structure assessment and extensive glyco-profiling of cetuximab by a combination of intact, middle-up, middle-down and bottom-up ESI and MALDI mass spectrometry techniques. MAbs 2013; 5; http://dx.doi.org/10.4161/mabs.25423; PMID: 23255090
  • Cheraghali AM. Current status of biopharmaceuticals in Iran’s pharmaceutical market. GaBI J 2013; 2:26 - 9; http://dx.doi.org/10.5639/gabij.2013.0201.008
  • McCamish M, Woollett G. The continuum of comparability extends to biosimilarity: how much is enough and what clinical data are necessary?. Clin Pharmacol Ther 2013; 93:315 - 7; http://dx.doi.org/10.1038/clpt.2013.17; PMID: 23443756
  • Damen CW, Chen W, Chakraborty AB, van Oosterhout M, Mazzeo JR, Gebler JC, et al. Electrospray ionization quadrupole ion-mobility time-of-flight mass spectrometry as a tool to distinguish the lot-to-lot heterogeneity in N-glycosylation profile of the therapeutic monoclonal antibody trastuzumab. J Am Soc Mass Spectrom 2009; 20:2021 - 33; http://dx.doi.org/10.1016/j.jasms.2009.07.017; PMID: 19744865
  • Schiestl M, Stangler T, Torella C, Cepeljnik T, Toll H, Grau R. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol 2011; 29:310 - 2; http://dx.doi.org/10.1038/nbt.1839; PMID: 21478841
  • Sundaram S, Matathia A, Qian J, Zhang J, Hsieh MC, Liu T, et al. An innovative approach for the characterization of the isoforms of a monoclonal antibody product. MAbs 2011; 3:505 - 12; http://dx.doi.org/10.4161/mabs.3.6.18090; PMID: 22123057
  • Janin-Bussat MC, Tonini L, Huillet C, Colas O, Klinguer-Hamour C, Corvaïa N, et al. Cetuximab Fab and Fc N-glycan fast characterization using IdeS digestion and liquid chromatography coupled to electrospray ionization mass spectrometry. Methods Mol Biol 2013; 988:93 - 113; http://dx.doi.org/10.1007/978-1-62703-327-5_7; PMID: 23475716
  • Toyama A, Nakagawa H, Matsuda K, Sato TA, Nakamura Y, Ueda K. Quantitative structural characterization of local N-glycan microheterogeneity in therapeutic antibodies by energy-resolved oxonium ion monitoring. Anal Chem 2012; 84:9655 - 62; http://dx.doi.org/10.1021/ac3023372; PMID: 23004563
  • McCamish M, Woollett G. The rise of the biosimilar. Expert Rev Clin Pharmacol 2012; 5:597 - 9; http://dx.doi.org/10.1586/ecp.12.60; PMID: 23234317
  • McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther 2012; 91:405 - 17; http://dx.doi.org/10.1038/clpt.2011.343; PMID: 22318617
  • McCamish M, Woollett G. Worldwide experience with biosimilar development. MAbs 2011; 3:209 - 17; http://dx.doi.org/10.4161/mabs.3.2.15005; PMID: 21441787