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Volumn 38, Issue 8, 2013, Pages 914-924

Review article: Biosimilars are the next generation of drugs for liver and gastrointestinal diseases

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; ANTINEOPLASTIC AGENT; AVENT; B 1695501; BIOSIMILAR AGENT; CT P 13; EP 2006; ETANERCEPT; FOLIC ACID; GLYCERYL TRINITRATE; GP 2013; HD 203; HEMOGLOBIN; HEXAL; HUMAN GROWTH HORMONE; INFLIXIMAB; INTERFERON; LBEC 0101; METHOTREXATE; NEUTRALIZING ANTIBODY; PEGINTERFERON; PF 06410293; PLD 108; PR X 106; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RIBAVIRIN; RITUXIMAB; SB 309; SILAPRO; TUNEX; UNCLASSIFIED DRUG; XM 02;

EID: 84884910025     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.12477     Document Type: Review
Times cited : (61)

References (58)
  • 1
    • 48949117123 scopus 로고    scopus 로고
    • Pharmacy and pharmacology of biosimilars
    • Krämer I,. Pharmacy and pharmacology of biosimilars. J Endocrinol Invest 2008; 31: 479-88.
    • (2008) J Endocrinol Invest , vol.31 , pp. 479-488
    • Krämer, I.1
  • 2
    • 51349137409 scopus 로고    scopus 로고
    • Toward biosimilar monoclonal antibodies
    • Schneider CK, Kalinke U,. Toward biosimilar monoclonal antibodies. Nat Biotechnol 2008; 26: 985-90.
    • (2008) Nat Biotechnol , vol.26 , pp. 985-990
    • Schneider, C.K.1    Kalinke, U.2
  • 4
    • 70450195261 scopus 로고    scopus 로고
    • Controlling the cost of innovative cancer therapeutics
    • Malik NN,. Controlling the cost of innovative cancer therapeutics. Nat Rev Clin Oncol 2009; 6: 550-2.
    • (2009) Nat Rev Clin Oncol , vol.6 , pp. 550-552
    • Malik, N.N.1
  • 5
    • 84884909992 scopus 로고    scopus 로고
    • Accessed July 10, 2013
    • 2010 report generic savings GPhA. Available at: http://www. prescriptionaccess.org/2010-Report-Generic-Savings-GPhA.pdf. Accessed July 10, 2013.
    • 2010 Report Generic Savings GPhA
  • 6
    • 84884904506 scopus 로고    scopus 로고
    • Accessed July 10, 2013
    • Congressional budget office cost estimate. Available at: http://www.cbo.gov/sites/default/files/cbofiles/ftpdocs/94xx/doc9496/s1695.pdf. Accessed July 10, 2013.
    • Congressional Budget Office Cost Estimate
  • 7
    • 77957723026 scopus 로고    scopus 로고
    • Biosimilar epoetins and other 'follow-on' biologics: Update on the European experiences
    • Jelkmann W,. Biosimilar epoetins and other 'follow-on' biologics: update on the European experiences. Am J Hematol 2010; 85: 771-80.
    • (2010) Am J Hematol , vol.85 , pp. 771-780
    • Jelkmann, W.1
  • 9
    • 84871492817 scopus 로고    scopus 로고
    • Biosimilars: What clinicians should know
    • Weise M, Bielsky M-C, De Smet K, et al,. Biosimilars: what clinicians should know. Blood 2012; 120: 5111-7.
    • (2012) Blood , vol.120 , pp. 5111-5117
    • Weise, M.1    Bielsky, M.-C.2    De Smet, K.3
  • 11
    • 0036598634 scopus 로고    scopus 로고
    • Bioequivalence and the immunogenicity of biopharmaceuticals
    • Schellekens H,. Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov 2002; 1: 457-62.
    • (2002) Nat Rev Drug Discov , vol.1 , pp. 457-462
    • Schellekens, H.1
  • 12
    • 0036499495 scopus 로고    scopus 로고
    • 'Biogenerics': The off-patent biotech products
    • Schellekens H, Ryff J-C,. 'Biogenerics': the off-patent biotech products. Trends Pharmacol Sci 2002; 23: 119-21.
    • (2002) Trends Pharmacol Sci , vol.23 , pp. 119-121
    • Schellekens, H.1    Ryff, J.-C.2
  • 13
    • 80054922640 scopus 로고    scopus 로고
    • NCCN Biosimilars White Paper: Regulatory, scientific, and patient safety perspectives
    • Zelenetz AD, Ahmed I, Braud EL, et al,. NCCN Biosimilars White Paper: regulatory, scientific, and patient safety perspectives. J Natl Compr Cancer Netw Jnccn 2011; 9 (Suppl. 4): S1-22.
    • (2011) J Natl Compr Cancer Netw Jnccn , vol.9 , Issue.SUPPL. 4
    • Zelenetz, A.D.1    Ahmed, I.2    Braud, E.L.3
  • 15
    • 20544470983 scopus 로고    scopus 로고
    • Biosimilars, generic versions of the first generation of therapeutic proteins: Do they exist?
    • Crommelin D, Bermejo T, Bissig M, et al,. Biosimilars, generic versions of the first generation of therapeutic proteins: do they exist? Contrib Nephrol 2005; 149: 287-94.
    • (2005) Contrib Nephrol , vol.149 , pp. 287-294
    • Crommelin, D.1    Bermejo, T.2    Bissig, M.3
  • 16
    • 0141922918 scopus 로고    scopus 로고
    • Shifting paradigms: Biopharmaceuticals versus low molecular weight drugs
    • Crommelin DJA, Storm G, Verrijk R, et al,. Shifting paradigms: biopharmaceuticals versus low molecular weight drugs. Int J Pharm 2003; 266: 3-16.
    • (2003) Int J Pharm , vol.266 , pp. 3-16
    • Crommelin, D.J.A.1    Storm, G.2    Verrijk, R.3
  • 17
    • 79953861167 scopus 로고    scopus 로고
    • Acceptable changes in quality attributes of glycosylated biopharmaceuticals
    • Schiestl M, Stangler T, Torella C, et al,. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol 2011; 29: 310-2.
    • (2011) Nat Biotechnol , vol.29 , pp. 310-312
    • Schiestl, M.1    Stangler, T.2    Torella, C.3
  • 18
    • 84857233319 scopus 로고    scopus 로고
    • The state of the art in the development of biosimilars
    • McCamish M, Woollett G,. The state of the art in the development of biosimilars. Clin Pharmacol Ther 2012; 91: 405-17.
    • (2012) Clin Pharmacol Ther , vol.91 , pp. 405-417
    • McCamish, M.1    Woollett, G.2
  • 19
    • 84884907874 scopus 로고    scopus 로고
    • Accessed July 12, 2013
    • GPhAcomments. Available at: http://www.elsevierbi.com/∼/media/ Supporting%20Documents/The%20Pink%20Sheet/74/17/GPhAcomments.pdf. Accessed July 12, 2013.
    • GPhAcomments
  • 20
    • 84872382872 scopus 로고    scopus 로고
    • Scientific considerations for assessing biosimilar products
    • Chow S-C, Wang J, Endrenyi L, et al,. Scientific considerations for assessing biosimilar products. Stat Med 2013; 32: 370-81.
    • (2013) Stat Med , vol.32 , pp. 370-381
    • Chow, S.-C.1    Wang, J.2    Endrenyi, L.3
  • 21
    • 33644952525 scopus 로고    scopus 로고
    • Accessed July 11, 2013
    • Guideline on similar biological medicinal products. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/ 09/WC500003517.pdf. Accessed July 11, 2013.
    • Guideline on Similar Biological Medicinal Products
  • 23
    • 84884909536 scopus 로고    scopus 로고
    • Accessed July 11, 2013
    • CHAPTER 1 marketing authorisation rev, 2005. Available at: http://ec.europa.eu/health/files/eudralex/vol-2/a/vol2a-chap1-2005-11-en.pdf. Accessed July 11, 2013.
    • (2005) CHAPTER 1 Marketing Authorisation Rev
  • 29
    • 79952749322 scopus 로고    scopus 로고
    • Biosimilar agents in oncology/haematology: From approval to practice
    • Niederwieser D, Schmitz S,. Biosimilar agents in oncology/haematology: from approval to practice. Eur J Haematol 2011; 86: 277-88.
    • (2011) Eur J Haematol , vol.86 , pp. 277-288
    • Niederwieser, D.1    Schmitz, S.2
  • 32
    • 0346554747 scopus 로고    scopus 로고
    • Accessed July 11, 2013
    • WHO expert committee on biological standardization. Available at: http://www.who.int/biologicals/areas/biological-therapeutics/ BIOTHERAPEUTICS-FOR-WEB-22APRIL2010.pdf. Accessed July 11, 2013.
    • WHO Expert Committee on Biological Standardization
  • 33
    • 84879555074 scopus 로고    scopus 로고
    • Clinical trial design in biosimilar drug development
    • Dranitsaris G, Dorward K, Hatzimichael E, et al,. Clinical trial design in biosimilar drug development. Invest New Drugs 2013; 31: 479-87.
    • (2013) Invest New Drugs , vol.31 , pp. 479-487
    • Dranitsaris, G.1    Dorward, K.2    Hatzimichael, E.3
  • 34
    • 79955510087 scopus 로고    scopus 로고
    • Through the looking glass: Understanding non-inferiority
    • Schumi J, Wittes JT,. Through the looking glass: understanding non-inferiority. Trials 2011; 12: 106.
    • (2011) Trials , vol.12 , pp. 106
    • Schumi, J.1    Wittes, J.T.2
  • 35
    • 0037472909 scopus 로고    scopus 로고
    • Design and analysis of non-inferiority mortality trials in oncology
    • Rothmann M, Li N, Chen G, et al,. Design and analysis of non-inferiority mortality trials in oncology. Stat Med 2003; 22: 239-64.
    • (2003) Stat Med , vol.22 , pp. 239-264
    • Rothmann, M.1    Li, N.2    Chen, G.3
  • 36
  • 37
    • 0020308864 scopus 로고
    • 'Proving the null hypothesis' in clinical trials
    • Blackwelder WC,. 'Proving the null hypothesis' in clinical trials. Control Clin Trials 1982; 3: 345-53.
    • (1982) Control Clin Trials , vol.3 , pp. 345-353
    • Blackwelder, W.C.1
  • 38
    • 79952488808 scopus 로고    scopus 로고
    • Quality of original and biosimilar epoetin products
    • Brinks V, Hawe A, Basmeleh AHH, et al,. Quality of original and biosimilar epoetin products. Pharm Res 2011; 28: 386-93.
    • (2011) Pharm Res , vol.28 , pp. 386-393
    • Brinks, V.1    Hawe, A.2    Basmeleh, A.H.H.3
  • 39
    • 67650067226 scopus 로고    scopus 로고
    • Bioequivalence of HX575 (recombinant human epoetin alfa) and a comparator epoetin alfa after multiple intravenous administrations: An open-label randomised controlled trial
    • Sörgel F, Thyroff-Friesinger U, Vetter A, et al,. Bioequivalence of HX575 (recombinant human epoetin alfa) and a comparator epoetin alfa after multiple intravenous administrations: an open-label randomised controlled trial. BMC Clin Pharmacol 2009; 9: 10.
    • (2009) BMC Clin Pharmacol , vol.9 , pp. 10
    • Sörgel, F.1    Thyroff-Friesinger, U.2    Vetter, A.3
  • 40
    • 70350776252 scopus 로고    scopus 로고
    • Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis
    • Haag-Weber M, Vetter A, Thyroff-Friesinger U, et al,. Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis. Clin Nephrol 2009; 72: 380-90.
    • (2009) Clin Nephrol , vol.72 , pp. 380-390
    • Haag-Weber, M.1    Vetter, A.2    Thyroff-Friesinger, U.3
  • 41
    • 84864558128 scopus 로고    scopus 로고
    • Prospective multicenter study of HX575 (biosimilar epoetin-α) in patients with chronic kidney disease applying a target hemoglobin of 10-12 g/dl
    • Hörl WH, Locatelli F, Haag-Weber M, et al,. Prospective multicenter study of HX575 (biosimilar epoetin-α) in patients with chronic kidney disease applying a target hemoglobin of 10-12 g/dl. Clin Nephrol 2012; 78: 24-32.
    • (2012) Clin Nephrol , vol.78 , pp. 24-32
    • Hörl, W.H.1    Locatelli, F.2    Haag-Weber, M.3
  • 42
    • 84884901120 scopus 로고    scopus 로고
    • Epoetin biosimilars in Europe: Five years on
    • Mikhail A, Farouk M,. Epoetin biosimilars in Europe: five years on. Adv Ther 2013; 30: 28-40.
    • (2013) Adv Ther , vol.30 , pp. 28-40
    • Mikhail, A.1    Farouk, M.2
  • 43
    • 79958824101 scopus 로고    scopus 로고
    • Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies
    • Praditpornsilpa K, Tiranathanagul K, Kupatawintu P, et al,. Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies. Kidney Int 2011; 80: 88-92.
    • (2011) Kidney Int , vol.80 , pp. 88-92
    • Praditpornsilpa, K.1    Tiranathanagul, K.2    Kupatawintu, P.3
  • 44
    • 84884910324 scopus 로고    scopus 로고
    • Accessed July 15, 2013
    • European Medicines Agency. Assessment report for ratiograstim. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Public-assessment- report/human/000825/WC500047793.pdf. Accessed July 15, 2013.
    • Assessment Report for Ratiograstim
  • 45
    • 84880228272 scopus 로고    scopus 로고
    • Mobilization of PBSC for allogeneic transplantation by the use of the G-CSF biosimilar XM02 in healthy donors
    • Schmitt M, Xu X, Hilgendorf I, et al,. Mobilization of PBSC for allogeneic transplantation by the use of the G-CSF biosimilar XM02 in healthy donors. Bone Marrow Transplant 2013; 48: 922-5.
    • (2013) Bone Marrow Transplant , vol.48 , pp. 922-925
    • Schmitt, M.1    Xu, X.2    Hilgendorf, I.3
  • 46
    • 84879080850 scopus 로고    scopus 로고
    • Use of a biosimilar granulocyte colony-stimulating factor for peripheral blood stem cell mobilization: An analysis of mobilization and engraftment
    • Publicover A, Richardson DS, Davies A, et al,. Use of a biosimilar granulocyte colony-stimulating factor for peripheral blood stem cell mobilization: an analysis of mobilization and engraftment. Br J Haematol 2013; 162: 107-11.
    • (2013) Br J Haematol , vol.162 , pp. 107-111
    • Publicover, A.1    Richardson, D.S.2    Davies, A.3
  • 47
    • 84883879484 scopus 로고    scopus 로고
    • Physicochemical and functional comparability between the proposed biosimilar rituximab GP2013 and originator rituximab
    • (in press). PMID: 23649935
    • Visser J, Feuerstein I, Stangler T, et al,. Physicochemical and functional comparability between the proposed biosimilar rituximab GP2013 and originator rituximab. Biodrugs Clin Immunother Biopharm Gene Ther 2013 (in press). PMID: 23649935.
    • (2013) Biodrugs Clin Immunother Biopharm Gene Ther
    • Visser, J.1    Feuerstein, I.2    Stangler, T.3
  • 48
    • 84862012415 scopus 로고    scopus 로고
    • Therapeutic effectiveness of biosimilar standard interferon versus pegylated interferon for chronic hepatitis C genotypes 2 or 3
    • Vigani AG, Gonçales ES, Pavan MHP, et al,. Therapeutic effectiveness of biosimilar standard interferon versus pegylated interferon for chronic hepatitis C genotypes 2 or 3. Braz J Infect Dis Off Publ Braz Soc Infect Dis 2012; 16: 232-6.
    • (2012) Braz J Infect Dis off Publ Braz Soc Infect Dis , vol.16 , pp. 232-236
    • Vigani, A.G.1    Gonçales, E.S.2    Pavan, M.H.P.3
  • 49
    • 85041196657 scopus 로고    scopus 로고
    • Therapy: Biosimilar CT-P13 comparable to infliximab in active RA
    • Therapy: biosimilar CT-P13 comparable to infliximab in active RA. Nat Rev Rheumatol 2013; 9: 382.
    • (2013) Nat Rev Rheumatol , vol.9 , pp. 382
  • 50
    • 84884907878 scopus 로고    scopus 로고
    • Accessed July 11, 2013
    • Appendix A PLANETAS study Ann Rheum Dis, 2013. Available at: http://ard.bmj.com.gate2.inist.fr/content/suppl/2013/05/16/annrheumdis-2012- 203091.DC1/annrheumdis-2012-203091supp-appendixA.pdf. Accessed July 11, 2013.
    • (2013) Appendix A PLANETAS Study Ann Rheum Dis
  • 51
    • 84883746909 scopus 로고    scopus 로고
    • A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: The PLANETAS study
    • (in press). PMID: 23687259
    • Park W, Hrycaj P, Jeka S, et al,. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 2013 (in press). PMID: 23687259.
    • (2013) Ann Rheum Dis
    • Park, W.1    Hrycaj, P.2    Jeka, S.3
  • 52
    • 84883752718 scopus 로고    scopus 로고
    • A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: The PLANETRA study
    • (in press). PMID: 23687260
    • Yoo DH, Hrycaj P, Miranda P, et al,. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 2013 (in press). PMID: 23687260.
    • (2013) Ann Rheum Dis
    • Yoo, D.H.1    Hrycaj, P.2    Miranda, P.3
  • 53
    • 84878624235 scopus 로고    scopus 로고
    • ECCO position statement: The use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD)
    • Governing Board and Operational Board of ECCO.
    • Danese S, Gomollon F,; Governing Board and Operational Board of ECCO. ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J Crohns Colitis 2013; 7: 586-589.
    • (2013) J Crohns Colitis , vol.7 , pp. 586-589
    • Danese, S.1    Gomollon, F.2
  • 54
    • 84876938678 scopus 로고    scopus 로고
    • Biosimilars in IBD: Hope or expectation?
    • Gecse KB, Khanna R, van den Brink GR, et al,. Biosimilars in IBD: hope or expectation? Gut 2013; 62: 803-7.
    • (2013) Gut , vol.62 , pp. 803-807
    • Gecse, K.B.1    Khanna, R.2    Van Den Brink, G.R.3
  • 55
    • 84884908508 scopus 로고    scopus 로고
    • Accessed July 11, 2013
    • EMA inflectra initial MAA-summary of opinion. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Summary-of-opinion-Initial- authorisation/human/002778/WC500144831.pdf. Accessed July 11, 2013.
    • EMA Inflectra Initial MAA - Summary of Opinion
  • 56
    • 83455201580 scopus 로고    scopus 로고
    • Comparative pharmacokinetics and tolerability of branded etanercept (25 mg) and its biosimilar (25 mg): A randomized, open-label, single-dose, two-sequence, crossover study in healthy Korean male volunteers
    • Gu N, Yi S, Kim T-E, et al,. Comparative pharmacokinetics and tolerability of branded etanercept (25 mg) and its biosimilar (25 mg): a randomized, open-label, single-dose, two-sequence, crossover study in healthy Korean male volunteers. Clin Ther 2011; 33: 2029-37.
    • (2011) Clin Ther , vol.33 , pp. 2029-2037
    • Gu, N.1    Yi, S.2    Kim, T.-E.3
  • 58
    • 79952715351 scopus 로고    scopus 로고
    • Biosimilar, biobetter and next generation therapeutic antibodies
    • Beck A,. Biosimilar, biobetter and next generation therapeutic antibodies. MAbs 2011; 3: 107-10.
    • (2011) MAbs , vol.3 , pp. 107-110
    • Beck, A.1


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