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Mediterr J Rheumatol 2019;30(Supp 1):54-8
From Basic Immunology to Clinical Practice: Bio-Originators versus Bio-Similars
Authors Information

1Division of Rheumatology, Department of Internal Medicine, Patras University Hospital, Rion, Patras, Greece
2University of Patras Medical School, Rion, Patras, Greece

References
  1. Scheinberg MA, Kay J. The advent of biosimilar therapies in rheumatology—“O brave new world”. Nat Rev Rheumatol 2012;8:430-6. [https://doi.org/10.1038/nrrheum.2012.84] [PMID: 22664834]
  2. Kay J, Smolen JS. Biosimilars to treat inflammatory arthritis: the challenge of proving identity. Ann Rheum Dis 2013;72:1589-93. [https://doi.org/10.1136/annrheumdis-2012-203198] [PMID: 23897773]
  3. Dorner T, Strand V, Castaneda-Hernandez G, Ferraccioli G, Isaacs JD, Kvien TK, et al. The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis 2013;72:322-8. [https://doi.org/10.1136/annrheumdis-2012-202715] [PMID: 23253920]
  4. Morrow T, Felcone LH. Defining the difference: What makes biologics unique. Biotechnol Health 2004;1:24-9. [PMID: 23393437] [PMCID: PMC3564302]
  5. Kuhlmann M, Covic A The protein science of biosimilars. Nephrol Dial Transplant 2006;21(Suppl 5):v4-8. [https://doi.org/10.1093/ndt/gfl474] [PMID: 16959791]
  6. Azevedo V, Hassett B, Fonseca JE, Atsumi T, Coindreau J, Jacobs I, et al. Differentiating biosimilarity and comparability in biotherapeutics. Clin Rheumatol 2016;35(12):2877-86. [https://doi.org/10.1007/s10067-016-3427-2] [PMID: 27734233]
  7. US Food and Drug Administration. Information for consumers (biosimilars). http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241718.htm; 2014. [Accessed on May 20, 2016].
  8. Pasina L, Casadei G, Nobili A. Biological agents and biosimilars: Essential information for the internist. Eur J Intern Med 2016;33:28-35. [https://doi.org/10.1016/j.ejim.2016.06.005] [PMID: 27342030]
  9. Declerck P, Farouk-Rezk M, Rudd P. Biosimilarity Versus Manufacturing Change: Two Distinct Concepts. Pharm Res 2016;33(2):261-8. [https://doi.org/10.1007/s11095-015-1790-3] [PMID: 26381277]
  10. McCamish M, Woollett G. Worldwide experience with biosimilar development. MAbs 2011;209-17. [https://doi.org/10.4161/mabs.3.2.15005] [PMID: 21441787] [PMCID: PMC3092622]
  11. Kvamme MK, Lie E, Uhlig T, Moger TA, Kvien TK, Kristiansen IS. Cost-effectiveness of TNF inhibitors versus synthetic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis: a Markov model study based on two longitudinal observational studies. Rheumatology (Oxford) 2015;54(7):1226-35. [https://doi.org/10.1093/rheumatology/keu460] [PMID: 25573840]
  12. 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. [https://doi.org/10.1038/nbt.2447] [PMID: 23222783]
  13. Hulse J, Cox C. In vitro functional testing methods for monoclonal antibody biosimilars. Bioprocess Int 2013;11:24-7.
  14. Kuhlmann M, Covic A. The protein science of biosimilars. Nephrol Dial Transplant 2006; 21(Suppl 5):v4-8. [https://doi.org/10.1093/ndt/gfl474] [PMID: 16959791]
  15. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol 2008; 19:411-9. [https://doi.org/10.1093/annonc/mdm345] [PMID: 17872902]
  16. Dranitsaris G, Dorward K, Hatzimichael E, Amir E. Clinical trial design in biosimilar drug development. Invest New Drugs 2013;31:479-87. [https://doi.org/10.1007/s10637-012-9899-2] [PMID: 23161336]
  17. Bendtzen K. Immunogenicity of anti-TNF-α biotherapies: I. Individualized medicine based on immunopharmacological evidence. Front Immunol 2015;6:152. [https://doi.org/10.3389/fimmu.2015.00152] [PMID: 25904915] [PMCID: PMC4389569]
  18. Scott C. A Decade of Characterization. Bioprocess Int 2012;10:58-61.
  19. Tsuruta LR, Lopes Dos Santos M, Moro AM. Biosimilars advancements: moving on to the future. Biotechnol Prog 2015;31:1139-49. [https://doi.org/10.1002/btpr.2066] [PMID: 25708573]
  20. Conlon HD, Thompson M, Ng CK, Rouse JC, Porter TJ. Analytical challenges during the development of a biosimilar. Presented at: Annual Meeting of the IBC Bioprocess International Conference; October 20-23, 2014; Boston, MA.
  21. European Medicines Agency. Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use, (http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128688.pdf; Accessed 15.05.15).
  22. European Medicines Agency (2013) Guideline on similar biological medicinal products.(http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500142978.pdf; Accessed 23.04.14).
  23. US Food and Drug Administration (2012) Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf; Accessed 23.04.14).
  24. Chow SC, Endrenyi L, Lachenbruch PA, Yang L-Y, Chi E. Scientific factors for assessing biosimilarity and drug interchangeability of follow-on biologics. Biosimilars 2011;1:13-26. [https://doi.org/10.2147/BS.S20577]
  25. Schellekens H. Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov 2002;1:457-62. [https://doi.org/10.1038/nrd818] [PMID: 12119747]
  26. Schellekens H. Biosimilar therapeutic agents: issues with bioequivalence and immunogenicity. Eur J Clin Invest 2004;34:797-9. [https://doi.org/10.1111/j.1365-2362.2004.01428.x] [PMID: 15606720]
  27. Kessler M, Goldsmith D, Schellekens H. Immunogenicity of biopharmaceuticals. Nephrol Dial Transplant 2006;21 Suppl 5:v9-12. [https://doi.org/10.1093/ndt/gfl476] [PMID: 16959792]
  28. Schellekens H, Casadevall N. Immunogenicity of recombinant human proteins: causes and consequences. J Neurol 2004;251 Suppl 2:II4-9. [https://doi.org/10.1007/s00415-004-1202-9] [PMID: 15264106]
  29. Schellekens H. Immunogenicity of therapeutic proteins: clinical implications and future prospects. Clin Ther 2002;24:1720-40; discussion 1719. [PMID: 12501870]
  30. Van Schouwenburg PA, Van De Stadt LA, De Jong RN, Van Buren EE, Kruithof S, De Groot E, et al. Adalimumab elicits a restricted anti-idiotypic antibody response in autoimmune patients resulting in functional neutralisation. Ann Rheum Dis 2013;72(1):104-9. [https://doi.org/10.1136/annrheumdis-2012-201445] [PMID: 22759910]
  31. Fasanmade AA, Adedokun OJ, Ford J, Hernandez D, Johanns J, Hu C, et al. Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis. Eur J Clin Pharmacol 2009;65:1211-28. [https://doi.org/10.1007/s00228-009-0718-4] [PMID: 19756557] [PMCID: PMC2778780]
  32. Klotz U, Teml A, Schwab M. Clinical pharmacokinetics and use of infliximab. Clin Pharmacokinet 2007;46,64-60. [https://doi.org/10.2165/00003088-200746080-00002] [PMID: 17655372]
  33. Reinisch W, Smolen J. Biosimilar safety factors in clinical practice. Semin Arthritis Rheum 2015;44(6)S9-15. [https://doi.org/10.1016/j.semarthrit.2015.04.005] [PMID: 26058551]
  34. Lie G, Sciascia S, Cuadrado M. Biosimilar vs biological agents in rheumatology: When are biosimilar agents similar enough? Int Immunopharmacol 2015;27(2):220-3. [https://doi.org/10.1016/j.intimp.2015.04.022] [PMID: 25907240]
  35. Mendes De Abreu M, Strand V, Levy R, Araujo DV. Putting the value into biosimilar decision making. The judgment value criteria. Autoimmun Rev 2014;13(6):678-84. [https://doi.org/10.1016/j.autrev.2014.01.051] [PMID: 24440285]
  36. Garattini L, Curto A, Van De Vooren K. Western European markets for biosimilar and generic drugs: worth differentiating. Eur J Health Econ 2015;16:683-7. [https://doi.org/10.1007/s10198-015-0684-y] [PMID: 25791078]
  37. 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. [https://doi.org/10.1038/nbt.1936] [PMID: 21822237]
  38. Beck A, Debaene F, Diemer H, Wagner-Rousset E, Colas O, Van Dorsselaer A, et al. Cutting-edge mass spectrometry characterization of originator, biosimilar and biobetter antibodies. J Mass Spectrom 2015;50:285-97. [https://doi.org/10.1002/jms.3554] [PMID: 25800010]