-
2
-
-
84930087840
-
-
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
-
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
-
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
-
-
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
-
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
-
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
-
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
-
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
-
-
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
-
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
-
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
-
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
-
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
-
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
-
-
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
-
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
-
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
-
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
-
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
-
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
-
22
-
-
35348948534
-
Immunological responses to exogenous insulin
-
COI: 1:CAS:528:DC%2BD2sXht1yit7rF, PID: 1778542
-
Fineberg SE, Kawabata TT, Finco-Kent D, Fountaine RJ, Finch GL, Krasner AS (2007) Immunological responses to exogenous insulin. Endocr Rev 28:625–652
-
(2007)
Endocr Rev
, vol.28
, pp. 625-652
-
-
Fineberg, S.E.1
Kawabata, T.T.2
Finco-Kent, D.3
Fountaine, R.J.4
Finch, G.L.5
Krasner, A.S.6
-
23
-
-
84979854585
-
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
-
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
-
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
-
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
-
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
-
-
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
-
-
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
-
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
-
-
-
39
-
-
84918524651
-
Traceability of biologicals: present challenges in pharmacovigilance
-
COI: 1:CAS:528:DC%2BC2cXitFahtLvP, PID: 2536976
-
Vermeer NS, Spierings I, Mantel-Teeuwisse AK, Straus SM, Giezen TJ, Leufkens HG, Egberts TC, De Bruin ML (2015) Traceability of biologicals: present challenges in pharmacovigilance. Expert Opin Drug Saf. 14:63–72
-
(2015)
Expert Opin Drug Saf
, vol.14
, pp. 63-72
-
-
Vermeer, N.S.1
Spierings, I.2
Mantel-Teeuwisse, A.K.3
Straus, S.M.4
Giezen, T.J.5
Leufkens, H.G.6
Egberts, T.C.7
De Bruin, M.L.8
-
40
-
-
17844366885
-
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
-
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
-
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
-
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
-
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
-
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
-
-
|