메뉴 건너뛰기




Volumn 52, Issue 3, 2015, Pages 423-431

The advent of biosimilars for the treatment of diabetes: current status and future directions

Author keywords

Biosimilar; Insulin; Pharmacovigilance; Substitution

Indexed keywords

BIOSIMILAR AGENT; HUMAN INSULIN; INSULIN; INSULIN DERIVATIVE; ISOPHANE INSULIN; RECOMBINANT HUMAN INSULIN; SHORT ACTING INSULIN;

EID: 84930092437     PISSN: 09405429     EISSN: 14325233     Source Type: Journal    
DOI: 10.1007/s00592-015-0771-7     Document Type: Article
Times cited : (17)

References (46)
  • 2
    • 84930087840 scopus 로고    scopus 로고
    • CHMP: guideline on similar biological medicinal products. Accessed 15 Feb 201
    • CHMP: guideline on similar biological medicinal products. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500142978.pdf. Accessed 15 Feb 2015
  • 3
    • 84913578640 scopus 로고    scopus 로고
    • Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
    • Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. London: EMA, 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf. Accessed 15 Feb 2015
    • (2014) London: EMA
  • 4
    • 84871639510 scopus 로고    scopus 로고
    • Opportunities and Challenges for Biosimilars: what’s on the horizon in the global insulin market?
    • Rotenstein LS, Ran N, Shivers JP, Yarchoan M, Close KL (2012) Opportunities and Challenges for Biosimilars: what’s on the horizon in the global insulin market? Clin Diabetes 30:138–150
    • (2012) Clin Diabetes , vol.30 , pp. 138-150
    • Rotenstein, L.S.1    Ran, N.2    Shivers, J.P.3    Yarchoan, M.4    Close, K.L.5
  • 5
    • 84930090593 scopus 로고    scopus 로고
    • European Medicines Agency. Pending EC Decision. Accessed 15 Feb 201
    • European Medicines Agency. Pending EC Decision. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002835/smops/Positive/human_smop_000706.jsp&mid=WC0b01ac058001d127. Accessed 15 Feb 2015
  • 6
    • 84929463818 scopus 로고    scopus 로고
    • Profitability in the biosimilars market: can you translate scientific excellence into a healthy commercial return?
    • Emerton DA (2013) Profitability in the biosimilars market: can you translate scientific excellence into a healthy commercial return? BioProcess Int 11(6–14):23
    • (2013) BioProcess Int , vol.11 , Issue.6-14 , pp. 23
    • Emerton, D.A.1
  • 7
    • 84900554442 scopus 로고    scopus 로고
    • Drug development and potential regulatory paths for insulin biosimilars
    • COI: 1:CAS:528:DC%2BC2cXhslCnsbzO, PID: 2487653
    • Minocha M, Gobburu J (2014) Drug development and potential regulatory paths for insulin biosimilars. J Diabetes Sci Technol 8:14–19
    • (2014) J Diabetes Sci Technol , vol.8 , pp. 14-19
    • Minocha, M.1    Gobburu, J.2
  • 8
    • 36348937220 scopus 로고    scopus 로고
    • Biosimilar drugs: concerns and opportunities
    • Genazzani AA, Biggio G, Caputi AP et al (2007) Biosimilar drugs: concerns and opportunities. Bio Drugs 21:351–356
    • (2007) Bio Drugs , vol.21 , pp. 351-356
    • Genazzani, A.A.1    Biggio, G.2    Caputi, A.P.3
  • 9
    • 84925047451 scopus 로고    scopus 로고
    • Why is there no generic insulin? Historical origins of a modern problem
    • COI: 1:CAS:528:DC%2BC2MXlsVars7o%3D, PID: 2578597
    • Greene JA, Riggs KR (2015) Why is there no generic insulin? Historical origins of a modern problem. N Engl J Med 372:1171–1175
    • (2015) N Engl J Med , vol.372 , pp. 1171-1175
    • Greene, J.A.1    Riggs, K.R.2
  • 10
    • 84930087371 scopus 로고    scopus 로고
    • Directive 2001/83/CE, modified by the Directive 2003/63/CE and by the Directive 2004/27/CE. Accessed 15 Feb 201
    • Directive 2001/83/CE, modified by the Directive 2003/63/CE and by the Directive 2004/27/CE. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/document_listing/document_listing_000349.jsp&mid=WC0b01ac05805083eblara. Accessed 15 Feb 2015
  • 11
    • 84979862938 scopus 로고    scopus 로고
    • Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)
    • Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1). London: EMA, 2012. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/05/WC500127960.pdf. Accessed 15 Feb 2015
    • (2012) London: EMA
  • 12
    • 0036598634 scopus 로고    scopus 로고
    • Bioequivalence and the immunogenicity of biopharmaceuticals
    • COI: 1:CAS:528:DC%2BD38Xkt1Cmur8%3D, PID: 1211974
    • Schellekens H (2002) Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov 1:457–462
    • (2002) Nat Rev Drug Discov , vol.1 , pp. 457-462
    • Schellekens, H.1
  • 13
    • 67349088299 scopus 로고    scopus 로고
    • How to systematically evaluate immunogenicity of therapeutic proteins—regulatory considerations
    • COI: 1:CAS:528:DC%2BD1MXms1Omt78%3
    • Jahn EM, Schneider CK (2009) How to systematically evaluate immunogenicity of therapeutic proteins—regulatory considerations. New Biotechnol 25:280–286
    • (2009) New Biotechnol , vol.25 , pp. 280-286
    • Jahn, E.M.1    Schneider, C.K.2
  • 14
    • 84921032525 scopus 로고    scopus 로고
    • Washington
    • Biologics Price Competition and Innovation Act of 2009 in the Patient Protection and Affordable Care Act (Public Law 111–148). Washington, D.C., 2010. http://www.gpo.gov/fdsys/pkg/PLAW-111publ148/content-detail.html. Accessed 15 Feb 2015
    • (2010) D.C
  • 15
    • 84979863447 scopus 로고    scopus 로고
    • Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues
    • Committee for Medicinal Products for Human Use. Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues. London: EMA, 2012. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/12/WC500136392.pdf. Accessed 15 Feb 2015
    • (2012) London: EMA
  • 16
    • 84930086365 scopus 로고    scopus 로고
    • Food and Drug Administration. Diabetes mellitus: developing drugs and therapeutic biologics for treatment and prevention. 2008. Accessed 15 Feb 201
    • Food and Drug Administration. Diabetes mellitus: developing drugs and therapeutic biologics for treatment and prevention. 2008. http://www.fda.gov/downloads/Drugs/Guidances/ucm071624.pdf. Accessed 15 Feb 2015
  • 17
    • 79961116944 scopus 로고    scopus 로고
    • Developing the nation’s biosimilars program
    • COI: 1:CAS:528:DC%2BC3MXpvFSitL8%3D, PID: 2181266
    • Kozlowski S, Woodcock J, Midthun K, Sherman RB (2011) Developing the nation’s biosimilars program. N Engl J Med 365:385–388
    • (2011) N Engl J Med , vol.365 , pp. 385-388
    • Kozlowski, S.1    Woodcock, J.2    Midthun, K.3    Sherman, R.B.4
  • 18
    • 19044374719 scopus 로고    scopus 로고
    • Biosimilar epoetins: how similar are they?
    • Schellekens H (2004) Biosimilar epoetins: how similar are they? Eur J Hosp Pharm 3:243–247
    • (2004) Eur J Hosp Pharm , vol.3 , pp. 243-247
    • Schellekens, H.1
  • 19
    • 77952509288 scopus 로고    scopus 로고
    • Lessons learned from biosimilar epoetins and insulins
    • COI: 1:CAS:528:DC%2BC3cXhtlKisL7
    • Kuhlmann M, Marre M (2010) Lessons learned from biosimilar epoetins and insulins. Br J Diabetes Vasc Dis 10:90–97
    • (2010) Br J Diabetes Vasc Dis , vol.10 , pp. 90-97
    • Kuhlmann, M.1    Marre, M.2
  • 20
    • 33748687181 scopus 로고    scopus 로고
    • The protein science of biosimilars
    • COI: 1:CAS:528:DC%2BD28XhtlSkt7%2FI, PID: 1695979
    • Kuhlmann M, Covic A (2006) The protein science of biosimilars. Nephrol Dial Transplant 21(Suppl 5):v4–v8
    • (2006) Nephrol Dial Transplant , vol.21 , pp. 4-8
    • Kuhlmann, M.1    Covic, A.2
  • 21
    • 19044395847 scopus 로고    scopus 로고
    • Follow-on biologics: challenges of the ‘‘next generation’’
    • PID: 1582705
    • Schellekens H (2005) Follow-on biologics: challenges of the ‘‘next generation’’. Nephrol Dial Transplant 20:iv31–iv36
    • (2005) Nephrol Dial Transplant , vol.20 , pp. 31-36
    • Schellekens, H.1
  • 23
    • 84979854585 scopus 로고    scopus 로고
    • London: EMEA, 2008
    • European Medicines Agency. Pre-authorisation evaluation of medicines for human use. Withdrawal Assessment Report for Insulin Human Rapid Marvel. 21 February 2008. London: EMEA, 2008. Document reference EMEA/CHMP/317778/2007. www.emea.europa.eu/humandocs/PDFs/EPAR/insulinhumanrapidmarvel/31777807en.pdf. Accessed 15 Feb 2015
    • (2008) Document reference EMEA/CHMP/317778/2007
  • 24
    • 84979862790 scopus 로고    scopus 로고
    • London: EMEA, 2008
    • European Medicines Agency. Pre-authorisation evaluation of medicines for human use. Withdrawal Assessment Report for Insulin Human Long Marvel. 21 February 2008. London: EMEA, 2008. Document reference EMEA/CHMP/70349/2008. www.emea.europa.eu/humandocs/PDFs/EPAR/insulinhumanrapidmarvel/7034908en.pdf. Accessed 15 Feb 2015
    • (2008) Document reference EMEA/CHMP/70349/2008
  • 25
    • 84979862287 scopus 로고    scopus 로고
    • London: EMEA, 2008
    • European Medicines Agency. Pre-authorisation evaluation of medicines for human use. Withdrawal Assessment Report for Insulin Human 30/70 Mixed Marvel. 21 February 2008. London: EMEA, 2008. Document reference EMEA/CHMP/70179/2008. www.emea.europa.eu/humandocs/PDFs/EPAR/insulinhumanrapidmarvel/701790en.pdf. Accessed 15 Feb 2015
    • (2008) Document reference EMEA/CHMP/70179/2008
  • 26
    • 84930088941 scopus 로고    scopus 로고
    • European Medicines Agency. Press release: Marvel LifeSciences Ltd withdraws its marketing authorisation applications for Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel. 16 January 2008. London: EMEA, 2008. EMEA/2435/200
    • European Medicines Agency. Press release: Marvel LifeSciences Ltd withdraws its marketing authorisation applications for Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel. 16 January 2008. London: EMEA, 2008. EMEA/2435/2008
  • 27
    • 84979854584 scopus 로고    scopus 로고
    • EMA/940451/2011
    • EMA Procedural advice for users of the centralized procedure for similar biological medicinal products applications. March 2013. EMA/940451/2011. Committee for Human Medicinal Products (CHMP) http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/04/WC500125166.pdf. Accessed 15 Feb 2015
    • (2013) Committee for Human Medicinal Products (CHMP)
  • 28
    • 84861679272 scopus 로고    scopus 로고
    • Allergy to human insulin and specific immunotherapy with glargine; case report with review of literature
    • COI: 1:CAS:528:DC%2BC38XhsV2qsrk%3D, PID: 2127952
    • Hasani-Ranjbar S, Fazlollahi MR, Mehri A, Larijani B (2012) Allergy to human insulin and specific immunotherapy with glargine; case report with review of literature. Acta Diabetol 49:69–73
    • (2012) Acta Diabetol , vol.49 , pp. 69-73
    • Hasani-Ranjbar, S.1    Fazlollahi, M.R.2    Mehri, A.3    Larijani, B.4
  • 29
    • 38749140300 scopus 로고    scopus 로고
    • The first biosimilar epoetin: but how similar is it?
    • PID: 1805730
    • Schellekens H (2008) The first biosimilar epoetin: but how similar is it? Clin J Am Soc Nephrol 3:174–178
    • (2008) Clin J Am Soc Nephrol , vol.3 , pp. 174-178
    • Schellekens, H.1
  • 30
    • 3042761213 scopus 로고    scopus 로고
    • Structure-immunogenicity relationships of therapeutic proteins
    • COI: 1:CAS:528:DC%2BD2cXktlykurY%3D, PID: 1521215
    • Hermeling S, Crommelin DJ, Schellekens H, Jiskoot W (2004) Structure-immunogenicity relationships of therapeutic proteins. Pharm Res 21:897–903
    • (2004) Pharm Res , vol.21 , pp. 897-903
    • Hermeling, S.1    Crommelin, D.J.2    Schellekens, H.3    Jiskoot, W.4
  • 32
    • 80052019009 scopus 로고    scopus 로고
    • Diabetic ketosis caused by the insulin analog aspart-induced anti-insulin antibody: successful treatment with the newest insulin analog glulisine
    • PID: 2161710
    • Yanai H, Adachi H, Hamasaki H (2011) Diabetic ketosis caused by the insulin analog aspart-induced anti-insulin antibody: successful treatment with the newest insulin analog glulisine. Diabetes Care 34:e108
    • (2011) Diabetes Care , vol.34 , pp. 108
    • Yanai, H.1    Adachi, H.2    Hamasaki, H.3
  • 33
    • 77951548027 scopus 로고    scopus 로고
    • Anti-infliximab and anti-adalimumab antibodies in relation to response to adalimumab in infliximab switchers and anti-tumour necrosis factor naive patients: a cohort study
    • COI: 1:CAS:528:DC%2BC3cXntlOks7w%3D, PID: 1958127
    • Bartelds GM, Wijbrandts CA, Nurmohamed MT, Stapel S, Lems WF, Aarden L, Dijkmans BA, Tak PP, Wolbink GJ (2010) Anti-infliximab and anti-adalimumab antibodies in relation to response to adalimumab in infliximab switchers and anti-tumour necrosis factor naive patients: a cohort study. Ann Rheum Dis 69:817–821
    • (2010) Ann Rheum Dis , vol.69 , pp. 817-821
    • Bartelds, G.M.1    Wijbrandts, C.A.2    Nurmohamed, M.T.3    Stapel, S.4    Lems, W.F.5    Aarden, L.6    Dijkmans, B.A.7    Tak, P.P.8    Wolbink, G.J.9
  • 34
    • 77955636779 scopus 로고    scopus 로고
    • Biosimilars: pharmacovigilance and risk management
    • PID: 2058320
    • Zuniga L, Calvo B (2010) Biosimilars: pharmacovigilance and risk management. Pharmacoepidemiol Drug Saf 19:661–669
    • (2010) Pharmacoepidemiol Drug Saf , vol.19 , pp. 661-669
    • Zuniga, L.1    Calvo, B.2
  • 35
    • 84979853426 scopus 로고    scopus 로고
    • Regulation (EU) No. 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No. 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No. 1394/2007 on advanced therapy medicinal products. Official Journal of the European Union L 348/1, 31/12/201
    • Regulation (EU) No. 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No. 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No. 1394/2007 on advanced therapy medicinal products. Official Journal of the European Union L 348/1, 31/12/2010
  • 36
    • 84930085658 scopus 로고    scopus 로고
    • Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official Journal of the European Union L 348/74, 31/12/201
    • Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official Journal of the European Union L 348/74, 31/12/2010
  • 37
    • 84930084969 scopus 로고    scopus 로고
    • Amendments to the pharmacovigilance legislation: new notification requirements for marketing-authorisation holders. 2013. Accessed 15 Feb 201
    • Amendments to the pharmacovigilance legislation: new notification requirements for marketing-authorisation holders. 2013. http://www.ema.europa.eu. Accessed 15 Feb 2015
  • 38
    • 72849136780 scopus 로고    scopus 로고
    • Biosimilar medicines and safety: new challenges for pharmacovigilance
    • Pharmacovigilance Focus. Biosimilar medicines and safety: new challenges for pharmacovigilance. WHO Drug Inf. 2009; 23:87–94. http://www.who.int/druginformation. Accessed 15 Feb 2015
    • (2009) WHO Drug Inf , vol.23 , pp. 87-94
  • 40
    • 17844366885 scopus 로고    scopus 로고
    • Therapeutic insulins and their large-scale manufacture
    • COI: 1:CAS:528:DC%2BD2MXjtlartrw%3D, PID: 1558049
    • Walsh G (2005) Therapeutic insulins and their large-scale manufacture. Appl Microbiol Biotechnol 67:151–159
    • (2005) Appl Microbiol Biotechnol , vol.67 , pp. 151-159
    • Walsh, G.1
  • 41
    • 36048991061 scopus 로고    scopus 로고
    • Insulin: history, biochemistry, physiology and pharmacology
    • PID: 1792700
    • Joshi SR, Parikh RM, Das AK (2007) Insulin: history, biochemistry, physiology and pharmacology. J Assoc Physicians India 55(suppl):19–25
    • (2007) J Assoc Physicians India , vol.55 , pp. 19-25
    • Joshi, S.R.1    Parikh, R.M.2    Das, A.K.3
  • 42
    • 78549247886 scopus 로고    scopus 로고
    • Insulin and its analogs: actions via insulin and IGF receptors
    • COI: 1:CAS:528:DC%2BC3cXhtlClu7nK, PID: 2073045
    • Vigneri R, Squatrito S, Sciacca L (2010) Insulin and its analogs: actions via insulin and IGF receptors. Acta Diabetol 47:271–278
    • (2010) Acta Diabetol , vol.47 , pp. 271-278
    • Vigneri, R.1    Squatrito, S.2    Sciacca, L.3
  • 43
    • 78349269200 scopus 로고    scopus 로고
    • Evolution of diabetes insulin delivery devices
    • PID: 2051331
    • Selam J-L (2010) Evolution of diabetes insulin delivery devices. J Diabetes Sci Technol 4:505–513
    • (2010) J Diabetes Sci Technol , vol.4 , pp. 505-513
    • Selam, J.-L.1
  • 44
    • 84979865860 scopus 로고    scopus 로고
    • Guideline on the suitability of the graduation of delivery devices for liquid dosage forms. Doc Ref EMEA/CHMP/QWP/178621/2004
    • European Medicines Agency. Guideline on the suitability of the graduation of delivery devices for liquid dosage forms. Doc Ref EMEA/CHMP/QWP/178621/2004. London: EMA, 2005. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003660.pdf. Accessed 15 Feb 2015
    • (2005) London: EMA
  • 45
    • 84979854601 scopus 로고    scopus 로고
    • Pen-injectors for medical use. Part 1: pen-injectors. Requirements and test methods (ISO 11608–1:2000)
    • International Organization for Standardization. Pen-injectors for medical use. Part 1: pen-injectors. Requirements and test methods (ISO 11608–1:2000). Geneva: ISO, 2000
    • (2000) Geneva: ISO


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.