메뉴 건너뛰기




Volumn 31, Issue 12, 2015, Pages 2325-2330

Biosimilars – terms of use

Author keywords

Biologics; Biosimilars; Interchangeability; Pharmacovigilance

Indexed keywords

BIOSIMILAR AGENT; DRUG ANTIBODY; GENERIC DRUG;

EID: 84977763676     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007995.2015.1098601     Document Type: Review
Times cited : (14)

References (42)
  • 2
    • 84872383751 scopus 로고    scopus 로고
    • Statistical methods for assessing interchangeability of biosimilars
    • Erratum in: Stat Med 2013;32:3234
    • Chow SC, Yang LY, Starr A, Chiu ST. Statistical methods for assessing interchangeability of biosimilars. Stat Med 2013;32:442-8. Erratum in: Stat Med 2013;32:3234
    • (2013) Stat Med , vol.32 , pp. 442-448
    • Chow, S.C.1    Yang, L.Y.2    Starr, A.3    Chiu, S.T.4
  • 4
    • 84871492817 scopus 로고    scopus 로고
    • Biosimilars: What clinicians should know
    • Weise M, Bielsky MC, De Smet K, et al. Biosimilars: what clinicians should know. Blood 2012;120:5111-17
    • (2012) Blood , vol.120 , pp. 5111-5117
    • Weise, M.1    Bielsky, M.C.2    De Smet, K.3
  • 6
    • 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 Network 2011;9(Suppl 4):S1-22
    • (2011) J Natl Compr Cancer Network , vol.9 , pp. S1-S22
    • Zelenetz, A.D.1    Ahmed, I.2    Braud, E.L.3
  • 7
    • 84878035306 scopus 로고    scopus 로고
    • Pharmacist perception of biosimilar agents in the U.S
    • Rana JB, Chang DY. Pharmacist perception of biosimilar agents in the U.S. Pharmacy Purchas Prod 2012;9:8
    • (2012) Pharmacy Purchas Prod , vol.9 , pp. 8
    • Rana, J.B.1    Chang, D.Y.2
  • 8
    • 33644952525 scopus 로고    scopus 로고
    • European Medicines Agency, [Last accessed June 2015]
    • European Medicines Agency. Guideline on similar biological medicinal products. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500142978.pdf [Last accessed June 2015]
    • Guideline on Similar Biological Medicinal Products
  • 9
    • 84893082014 scopus 로고    scopus 로고
    • Different pharmaceutical products need similar terminology
    • Crommelin DJA, de Vlieger JSB, Weinstein V, et al. Different pharmaceutical products need similar terminology. AAPS J 2014;16:11-14
    • (2014) AAPS J , vol.16 , pp. 11-14
    • Crommelin, D.1    De Vlieger, J.2    Weinstein, V.3
  • 10
    • 84860285348 scopus 로고    scopus 로고
    • On the regulatory approval pathway of biosimilar products
    • Wang J, Chow S. On the regulatory approval pathway of biosimilar products. Pharmaceuticals 2012;5:353-68
    • (2012) Pharmaceuticals , vol.5 , pp. 353-368
    • Wang, J.1    Chow, S.2
  • 11
    • 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
  • 12
    • 33748685217 scopus 로고    scopus 로고
    • Comparative testing and pharmacovigilance of biosimilars
    • Locatelli F, Roger S. Comparative testing and pharmacovigilance of biosimilars. Nephrol Dial Transplant 2006;21(Suppl 5):13-516
    • (2006) Nephrol Dial Transplant , vol.21 , pp. 13-516
    • Locatelli, F.1    Roger, S.2
  • 13
    • 60549104490 scopus 로고    scopus 로고
    • European Medicines Agency, European Medicines Agency – Europa, Last accessed June 2015
    • European Medicines Agency. EMEA CHMP Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins. European Medicines Agency – Europa 2007. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC 500003946.pdf [Last accessed June 2015]
    • (2007) EMEA CHMP Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins
  • 14
    • 84986898773 scopus 로고    scopus 로고
    • World Health Organization, World Health Organization, Last accessed June 2015
    • World Health Organization. World Health Organization Programme for International Drug Monitoring. World Health Organization. Available at: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/National_PV_Centres_Map/en/index.html#.UD3w-rOzzNM.email [Last accessed June 2015]
    • World Health Organization Programme for International Drug Monitoring
  • 15
    • 84896860472 scopus 로고    scopus 로고
    • EU’s new pharmacovigilance legislation: Considerations for biosimilars
    • Calvo B, Zuñiga L. EU’s new pharmacovigilance legislation: considerations for biosimilars. Drug Saf 2014;37:9-18
    • (2014) Drug Saf , vol.37 , pp. 9-18
    • Calvo, B.1    Zuñiga, L.2
  • 16
    • 84986875421 scopus 로고    scopus 로고
    • European Medicines Agency Public Assessment Reports, Last accessed June 2015
    • European Medicines Agency Public Assessment Reports. List of Medicines under Additional Monitoring. Available at: http://www.ema.europa.eu/ema/index.jsp?curl¼pages/regulation/document_listing/document_listing_0003 66.jsp&mid=WC0b01ac058067c852 [Last accessed June 2015]
    • List of Medicines under Additional Monitoring
  • 17
    • 84878900689 scopus 로고    scopus 로고
    • Pharmacovigilance and biosimilars: Considerations, needs and challenges
    • Casadevall N, Edwards IR, Felix T, et al. Pharmacovigilance and biosimilars: considerations, needs and challenges. Expert Opin Biol Ther 2013;13:1039-47
    • (2013) Expert Opin Biol Ther , vol.13 , pp. 1039-1047
    • Casadevall, N.1    Edwards, I.R.2    Felix, T.3
  • 18
    • 84878088510 scopus 로고    scopus 로고
    • The biosimilar pathway: Where will it lead us?
    • American Pharmacists Association, Dec
    • American Pharmacists Association. The biosimilar pathway: where will it lead us? Pharmacy Today 2011;Dec:67-76
    • (2011) Pharmacy Today , pp. 67-76
  • 19
    • 36448974120 scopus 로고    scopus 로고
    • Biotherapeutics in the era of biosimilars
    • Declerck P. Biotherapeutics in the era of biosimilars. Drug Safety 2007;30:1087-92
    • (2007) Drug Safety , vol.30 , pp. 1087-1092
    • Declerck, P.1
  • 20
    • 84960456112 scopus 로고    scopus 로고
    • World Health Organization Programme on International Nonproprietary Names (INN), Last accessed June 2015
    • World Health Organization Programme on International Nonproprietary Names (INN). Biological Qualifier – An INN Proposal. Available at: http://www.who.int/medicines/services/inn/bq_innproposal201407.pdf [Last accessed June 2015]
    • Biological Qualifier – an INN Proposal
  • 21
    • 84879129159 scopus 로고    scopus 로고
    • Potential concerns and challenges for P&T committees
    • Ventola CL. Potential concerns and challenges for P&T committees. P&T 2013;38:329-35
    • (2013) P&T , vol.38 , pp. 329-335
    • Ventola, C.L.1
  • 22
    • 84986916946 scopus 로고    scopus 로고
    • FDA Information for Healthcare Professionals on Biosimilars, Last accessed June 2015
    • FDA Information for Healthcare Professionals on Biosimilars. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241719.htm [Last accessed June 2015]
  • 23
  • 24
    • 84923353114 scopus 로고    scopus 로고
    • Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation
    • Scott BJ, Klein AV, Wang J. Biosimilar monoclonal antibodies: a Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation. J Clin Pharmacol 2015;55(Suppl 3):S123-32
    • (2015) J Clin Pharmacol , vol.55 , pp. SS32-S123
    • Scott, B.J.1    Klein, A.V.2    Wang, J.3
  • 25
    • 84871480483 scopus 로고    scopus 로고
    • Biosimilars might not measure up to health plan expectations
    • Reinke T. Biosimilars might not measure up to health plan expectations. Manag Care 2012;21:12-13
    • (2012) Manag Care , vol.21 , pp. 12-13
    • Reinke, T.1
  • 26
    • 84872423673 scopus 로고    scopus 로고
    • On the interchangeability of biologic drug products
    • Endrenyi L, Chang C, Chow SC, Tothfalusi L. On the interchangeability of biologic drug products. Stat Med 2013;32:434-41
    • (2013) Stat Med , vol.32 , pp. 434-441
    • Endrenyi, L.1    Chang, C.2    Chow, S.C.3    Tothfalusi, L.4
  • 27
    • 84883165568 scopus 로고    scopus 로고
    • NOR-SWITCH study, Last accessed June 2015
    • NOR-SWITCH study. Clinical Trials database. Available at: http://clinicaltrials.gov/ct2/show/record/NCT02148640 [Last accessed June 2015]
    • Clinical Trials Database
  • 28
    • 84986914922 scopus 로고    scopus 로고
    • Allen and Ovary, The Lawyer 2014, Last accessed June 2015
    • Allen and Ovary. Biosimilar substitution in France: no way back? The Lawyer 2014. Available at: http://www.thelawyer.com/briefings/biosimilarsubstitution-in-france-no-way-back/3014733.article [Last accessed June 2015]
    • Biosimilar Substitution in France: No Way Back?
  • 29
    • 84986874978 scopus 로고    scopus 로고
    • AIFA. Position paper, Last accessed June 2015
    • AIFA. Position paper. I farmaci biosimilari. Rome. Available at: http://www.agenziafarmaco.gov.it/sites/default/files/AIFA_POSITION_PAPER_FARMACI_BIOSIMILARI.pdf [Last accessed June 2015]
    • I Farmaci Biosimilari
  • 30
    • 84933675083 scopus 로고    scopus 로고
    • The challenging definition of naı¨ve patient for biological drug use
    • Biggioggero M, Danova M, Genovese U, et al. The challenging definition of naı¨ve patient for biological drug use. Autoimmun Rev 2015;14:543-6
    • (2015) Autoimmun Rev , vol.14 , pp. 543-546
    • Biggioggero, M.1    Danova, M.2    Genovese, U.3
  • 31
    • 84923998513 scopus 로고    scopus 로고
    • Biosimilars in oncology: Current and future perspectives
    • Aapro M. Biosimilars in oncology: current and future perspectives. Generics and Biosimilars Initiative Journal 2013;2:91-3
    • (2013) Generics and Biosimilars Initiative Journal , vol.2 , pp. 91-93
    • Aapro, M.1
  • 32
    • 84865461168 scopus 로고    scopus 로고
    • Clinical safety of biosimilar recombinant human erythropoietins
    • Abraham I, MacDonald K. Clinical safety of biosimilar recombinant human erythropoietins. Expert Opin Drug Saf 2012;11:819-40
    • (2012) Expert Opin Drug Saf , vol.11 , pp. 819-840
    • Abraham, I.1    Macdonald, K.2
  • 33
    • 79953154625 scopus 로고    scopus 로고
    • Comparison of the pharmacokinetic and pharmacodynamic profiles of one US-marketed and two European marketed epoetin alfas: A randomized prospective study
    • Lissy M, Ode M, Roth K. Comparison of the pharmacokinetic and pharmacodynamic profiles of one US-marketed and two European marketed epoetin alfas: a randomized prospective study. Drugs R D 2011;11:61-75
    • (2011) Drugs R D , vol.11 , pp. 61-75
    • Lissy, M.1    Ode, M.2    Roth, K.3
  • 34
    • 84986874962 scopus 로고    scopus 로고
    • Binocrit European Public Assessment Report, Last accessed in June 2015
    • Binocrit European Public Assessment Report. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-Conditions_imposed_on_member_states_for_safe_and_effective_use/human/000725/WC500053681.pdf [Last accessed in June 2015]
  • 35
    • 84900459730 scopus 로고    scopus 로고
    • Biosimilars in the therapy of inflammatory bowel diseases
    • Hlvaaty T, Letkovsky J. Biosimilars in the therapy of inflammatory bowel diseases. Eur J Gastroenterol Hepatol 2014;26:581-7
    • (2014) Eur J Gastroenterol Hepatol , vol.26 , pp. 581-587
    • Hlvaaty, T.1    Letkovsky, J.2
  • 36
    • 84883752718 scopus 로고    scopus 로고
    • A randomised, double-blind, parallelgroup 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
    • Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallelgroup 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;72:1613-20
    • (2013) Ann Rheum Dis , vol.72 , pp. 1613-1620
    • Yoo, D.H.1    Hrycaj, P.2    Miranda, P.3
  • 37
    • 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
    • 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;72:1605-12
    • (2013) Ann Rheum Dis , vol.72 , pp. 1605-1612
    • Park, W.1    Hrycaj, P.2    Jeka, S.3
  • 38
    • 84902275395 scopus 로고    scopus 로고
    • The biosimilar road in inflammatory bowel disease: The right way?
    • Fiorino G, Danese S. The biosimilar road in inflammatory bowel disease: the right way? Best Pract Res Clin Gastroenterol 2014;28:465-71
    • (2014) Best Pract Res Clin Gastroenterol , vol.28 , pp. 465-471
    • Fiorino, G.1    Danese, S.2
  • 39
    • 84884263009 scopus 로고    scopus 로고
    • Biosimilars: The paradox of sharing the same pharmacological action without full chemical identity
    • Pani L, Montilla S, Pimpinella G, Malgarini RB. Biosimilars: the paradox of sharing the same pharmacological action without full chemical identity. Expert Opin Biol Ther 2013;13:1343-6
    • (2013) Expert Opin Biol Ther , vol.13 , pp. 1343-1346
    • Pani, L.1    Montilla, S.2    Pimpinella, G.3    Malgarini, R.B.4
  • 40
    • 84905920752 scopus 로고    scopus 로고
    • First results from the phase III ALTTO trial (BIG 2-06; NCCTG [Alliance] N063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone (T), their sequence (T→L), or their combination (T+L) in the adjuvant treatment of HER2-positive early breast cancer (EBC)
    • abstr LBA4
    • Piccart-Gebhart MJ, Holmes AP, Baselga J, et al. First results from the phase III ALTTO trial (BIG 2-06; NCCTG [Alliance] N063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone (T), their sequence (T→L), or their combination (T+L) in the adjuvant treatment of HER2-positive early breast cancer (EBC). J Clin Oncol 2014;32:5s(abstr LBA4)
    • (2014) J Clin Oncol , vol.32
    • Piccart-Gebhart, M.J.1    Holmes, A.P.2    Baselga, J.3
  • 41
    • 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;7:586-9
    • (2013) J Crohns Colitis , vol.7 , pp. 586-589
    • Danese, S.1    Gomollon, F.2
  • 42
    • 84878532312 scopus 로고    scopus 로고
    • Joint position statement by Spanish Society of Gastroenterology and Spanish Society of Pharmacology on biosimilar therapy for inflammatory bowel disease
    • Arguelles-Arias F, Barreiro-de-Acosta M, Carballo F, et al. Joint position statement by Spanish Society of Gastroenterology and Spanish Society of Pharmacology on biosimilar therapy for inflammatory bowel disease. Rev Esp Enferm Dig 2013;105:37-43
    • (2013) Rev Esp Enferm Dig , vol.105 , pp. 37-43
    • Arguelles-Arias, F.1    Barreiro-De-Acosta, M.2    Carballo, F.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.