-
2
-
-
80051984166
-
Biosimilars of biological drug therapies: Regulatory, clinical and commercial considerations
-
Dranitsaris G, Amir E, Dorward K: Biosimilars of biological drug therapies: regulatory, clinical and commercial considerations. Drugs 2011;71:1527-1536.
-
(2011)
Drugs
, vol.71
, pp. 1527-1536
-
-
Dranitsaris, G.1
Amir, E.2
Dorward, K.3
-
3
-
-
77957122152
-
The new world of biosimilars: What diabetologists need to know about biosimilar insulins
-
Krämer I, Sauer T: The new world of biosimilars: what diabetologists need to know about biosimilar insulins. Br J Diabetes Vasc Dis 2010;10:163-171.
-
(2010)
Br J Diabetes Vasc Dis
, vol.10
, pp. 163-171
-
-
Krämer, I.1
Sauer, T.2
-
4
-
-
0037075272
-
Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin
-
DOI 10.1056/NEJMoa011931
-
Casadevall N, Nataf J, Viron B Kolta A, Kiladjian JJ, Martin- Dupont P, Michaud P, Papo T, Ugo V, Teyssandier I, Varet B, Mayeux P: Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med 2002;346:469-475. (Pubitemid 34441737)
-
(2002)
New England Journal of Medicine
, vol.346
, Issue.7
, pp. 469-475
-
-
Casadevall, N.1
Nataf, J.2
Viron, B.3
Kolta, A.4
Kiladjian, J.-J.5
Martin-Dupont, P.6
Michaud, P.7
Papo, T.8
Ugo, V.9
Teyssandier, I.10
Varet, B.11
Mayeux, P.12
-
5
-
-
33745096842
-
Eprex-associated pure red cell aplasia and leachates [1]
-
DOI 10.1038/nbt0606-613, PII N0606613
-
Schellekens H, Jiskoot W: Eprex-associated pure red cell aplasia and leachates. Nat Biotechnol 2006;24:613-614. (Pubitemid 43884419)
-
(2006)
Nature Biotechnology
, vol.24
, Issue.6
, pp. 613-614
-
-
Schellekens, H.1
Jiskoot, W.2
-
6
-
-
84868033485
-
-
U.S. Food and Drug Administration, U.S. Department of Health and Human Services (accessed August 2012)
-
U.S. Food and Drug Administration: Facts about generic drugs. U.S. Department of Health and Human Services. 2012. www.fda.gov/Drugs/ ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ ucm167991.htm (accessed August 2012).
-
(2012)
Facts about Generic Drugs
-
-
-
7
-
-
33644952525
-
-
Committee for Medicinal Products for Human Use (accessed August 2012)
-
Committee for Medicinal Products for Human Use: Guideline on similar biological medicinal products. CHMP/437/04 2005. 2005. www.ema.europa.eu/docs/ en-GB/document-library/Scientific-guideline/2009/09/WC500003517.pdf (accessed August 2012).
-
(2005)
Guideline on similar biological medicinal products. CHMP/437/04 2005
-
-
-
10
-
-
79961203419
-
Biosimilars - Why terminology matters
-
Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Narayanan G, Heim HK, Heinonen E, Ho K, Thorpe R, Vleminckx C, Wadhwa M, Schneider CK: Biosimilars - why terminology matters. Nat Biotechnol 2011;29:690-693.
-
(2011)
Nat Biotechnol
, vol.29
, pp. 690-693
-
-
Weise, M.1
Bielsky, M.C.2
De Smet, K.3
Ehmann, F.4
Ekman, N.5
Narayanan, G.6
Heim, H.K.7
Heinonen, E.8
Ho, K.9
Thorpe, R.10
Vleminckx, C.11
Wadhwa, M.12
Schneider, C.K.13
-
11
-
-
84858760623
-
Biosimilar insulins: How similar is similar?
-
Heinemann L, Hompesch M: Biosimilar insulins: how similar is similar? J Diabetes Sci Technol 2011;5:741-754.
-
(2011)
J Diabetes Sci Technol
, vol.5
, pp. 741-754
-
-
Heinemann, L.1
Hompesch, M.2
-
12
-
-
77952509288
-
Lessons learned from biosimilar epoetins and insulins
-
Kuhlmann M, Marre M: Lessons learned from biosimilar epoetins and insulins. Br J Diabetes Vasc Dis 2010;10:90-97.
-
(2010)
Br J Diabetes Vasc Dis
, vol.10
, pp. 90-97
-
-
Kuhlmann, M.1
Marre, M.2
-
13
-
-
0036598634
-
Bioequivalence and the immunogenicity of biopharmaceuticals
-
Schellekens H: Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov 2002;1:457-462. (Pubitemid 37361488)
-
(2002)
Nature Reviews Drug Discovery
, vol.1
, Issue.6
, pp. 457-462
-
-
Schellekens, H.1
-
14
-
-
38749140300
-
The first biosimilar epoetin: But how similar is it?
-
Schellekens H: The first biosimilar epoetin: but how similar is it? Clin J Am Soc Nephrol 2008;3:174-178.
-
(2008)
Clin J Am Soc Nephrol
, vol.3
, pp. 174-178
-
-
Schellekens, H.1
-
16
-
-
80052019009
-
Diabetic ketosis caused by the insulin analog aspart-induced anti-insulin antibody: Successful treatment with the newest insulin analog glulisine
-
Yanai H, Adachi H, Hamasaki H: Diabetic ketosis caused by the insulin analog aspart-induced anti-insulin antibody: successful treatment with the newest insulin analog glulisine. Diabetes Care 2011;34:e108.
-
(2011)
Diabetes Care
, vol.34
-
-
Yanai, H.1
Adachi, H.2
Hamasaki, H.3
-
17
-
-
35348948534
-
Immunological responses to exogenous insulin
-
DOI 10.1210/er.2007-0002
-
Fineberg SE, Kawabata TT, Finco-Kent D, Fountaine RJ, Finch GL, Krasner AS: Immunological responses to exogenous insulin. Endocr Rev 2007;28:625-652. (Pubitemid 47606649)
-
(2007)
Endocrine Reviews
, vol.28
, Issue.6
, 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
-
18
-
-
3042761213
-
Structure-immunogenicity relationships of therapeutic proteins
-
DOI 10.1023/B:PHAM.0000029275.41323.a6
-
Hermeling S, Crommelin DJ, Schellekens H, Jiskoot W: Structure- immunogenicity relationships of therapeutic proteins. Pharm Res 2004;21:897-903. (Pubitemid 38870136)
-
(2004)
Pharmaceutical Research
, vol.21
, Issue.6
, pp. 897-903
-
-
Hermeling, S.1
Crommelin, D.J.A.2
Schellekens, H.3
Jiskoot, W.4
-
19
-
-
33748041958
-
Effects of protein aggregates: An Immunologic perspective
-
DOI 10.1208/aapsj080359, 59
-
Rosenberg A: Effects of protein aggregates: an immunologic perspective. AAPS J 2006;8:E501-E507. (Pubitemid 44294011)
-
(2006)
AAPS Journal
, vol.8
, Issue.3
-
-
Rosenberg, A.S.1
-
21
-
-
84876163180
-
-
Pharmeuropa Online (accessed August 2012)
-
EDQM: Insulin glargine [draft monograph]. Pharmeuropa Online 2011;23:327-328. www.edqm.eu/store/images/majbdd/201103071151570. Contents%20of%20Phpa2302E.pdf (accessed August 2012).
-
(2011)
EDQM: Insulin Glargine [Draft Monograph]
, vol.23
, pp. 327-328
-
-
-
23
-
-
63449096194
-
A tandem mass spectrometric approach to the identification of O-glycosylated glargine glycoforms in active pharmaceutical ingredient expressed in Pichia pastoris
-
Kannan V, Narayanaswamy P, Gadamsetty D, Hazra P, Khedkar A, Iyer H: A tandem mass spectrometric approach to the identification of O-glycosylated glargine glycoforms in active pharmaceutical ingredient expressed in Pichia pastoris. Rapid Commun Mass Spectrom 2009;23:1035-1042.
-
(2009)
Rapid Commun Mass Spectrom
, vol.23
, pp. 1035-1042
-
-
Kannan, V.1
Narayanaswamy, P.2
Gadamsetty, D.3
Hazra, P.4
Khedkar, A.5
Iyer, H.6
-
24
-
-
84868032924
-
Structu al identification and qualitative analysis of recombinant insulin glargine-related impurities [in Chinese; English abstract]
-
Li J, Liang C, Zhang H, Yang H, Wang D: Structu al identification and qualitative analysis of recombinant insulin glargine-related impurities [in Chinese; English abstract]. Chin Pharm J 2008;43:1-12.
-
(2008)
Chin Pharm J
, vol.43
, pp. 1-12
-
-
Li, J.1
Liang, C.2
Zhang, H.3
Yang, H.4
Wang, D.5
-
25
-
-
84876177307
-
-
Committee For Medicinal Products For Human Use: Annex Guideline On Similar Biological Medicinal Products Containing Biotechnology-derived Proteins As Active Substance: Nonclinical And Clinical Issues (accessed August 2012)
-
Committee for Medicinal Products for Human Use: Annex guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: nonclinical and clinical issues. Guidance on similar medicinal products containing recombinant human insulin. EMEA/CHMP/32775/2005. www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/ WC500003957.pdf (accessed August 2012).
-
(2005)
Guidance on Similar Medicinal Products Containing Recombinant Human Insulin. EMEACHMP32775
-
-
-
28
-
-
0020684912
-
Human insulin from recombinant DNA technology
-
Johnson IS: Human insulin from recombinant DNA technology. Science 1983;219:632-637. (Pubitemid 13185414)
-
(1983)
Science
, vol.219
, Issue.4585
, pp. 632-637
-
-
Johnson, I.S.1
-
29
-
-
0041733061
-
Insulin glargine: An updated review of its use in the management of diabetes mellitus
-
DOI 10.2165/00003495-200363160-00007
-
Dunn CJ, Plosker GL, Keating GM, McKeage K, Scott LJ: Insulin glargine: an updated review of its use in the management of diabetes mellitus. Drugs 2003;63:1743-1778. (Pubitemid 36999964)
-
(2003)
Drugs
, vol.63
, Issue.16
, pp. 1743-1778
-
-
Dunn, C.J.1
Plosker, G.L.2
Keating, G.M.3
McKeage, K.4
Scott, L.J.5
-
30
-
-
84863809693
-
Studies of pharmacokinetic, pharmacodynamic properties and bioequivalence of recombinant insulin glargine injection in healthy man [in Chinese]
-
Cheng SW, Lu JM, Pan CU, Wang BA, Wang YZ, Li YJ, Yang G, Zuo WH: Studies of pharmacokinetic, pharmacodynamic properties and bioequivalence of recombinant insulin glargine injection in healthy man [in Chinese]. Chin J Diabetes 2010;18:387-393.
-
(2010)
Chin J Diabetes
, vol.18
, pp. 387-393
-
-
Cheng, S.W.1
Lu, J.M.2
Pan, C.U.3
Wang, B.A.4
Wang, Y.Z.5
Li, Y.J.6
Yang, G.7
Zuo, W.H.8
-
31
-
-
84964007640
-
A study on the control of fasting and postprandial hyperglycemia by glargine insulin combined with oral hypoglycemic agent [in Chinese]
-
Zhu L, He L, Gu Q, Zhang Y, Zou D: A study on the control of fasting and postprandial hyperglycemia by glargine insulin combined with oral hypoglycemic agent [in Chinese]. Chin J Diabetes 2009;17:690-692.
-
(2009)
Chin J Diabetes
, vol.17
, pp. 690-692
-
-
Zhu, L.1
He, L.2
Gu, Q.3
Zhang, Y.4
Zou, D.5
-
32
-
-
79954433316
-
Basalog is similar to Lantus in producing glycemic control in patients with type 1 diabetes mellitus on multiple daily insulin regimens
-
Verma M, Hazra P, Iyer H, Arun A, Akundi S, Dixit M, Eswaraiah A, Prasanna C, Atigna A: Basalog is similar to Lantus in producing glycemic control in patients with type 1 diabetes mellitus on multiple daily insulin regimens. Int J Diabetes Dev Countries 2011;31:26-31.
-
(2011)
Int J Diabetes Dev Countries
, vol.31
, pp. 26-31
-
-
Verma, M.1
Hazra, P.2
Iyer, H.3
Arun, A.4
Akundi, S.5
Dixit, M.6
Eswaraiah, A.7
Prasanna, C.8
Atigna, A.9
-
33
-
-
84876182524
-
-
Instituto Nacionalde Vigilanciade Medicamentosy Alimentos, Ministerio de la Proteccio'n Social, Bogata, Repú blicade Colombia (accessed August 2012)
-
Instituto Nacionalde Vigilanciade Medicamentosy Alimentos: Sala especializada de medicamentos y productos bioló gicos de la comisio'n revisora, Acta No. 31. Ministerio de la Proteccio'n Social, Bogata, Repú blicade Colombia. 2009. http://web.invima.gov.co/portal/documents/portal/ documents/root/acta312009-medicamentos.pdf (accessed August 2012).
-
(2009)
Sala Especializada de Medicamentos y Productos Bioló Gicos de la Comisio'n Revisora Acta No 31
-
-
-
39
-
-
85061953777
-
FDA regulation of follow-on biologics
-
(accessed August 2012)
-
Johnson JA: FDA regulation of follow-on biologics. RL34045. 2010. www.primaryimmune.org/advocacy-center/pdfs/health-care-reform/ Biosimilars-Congressional-Research-Service-Report.pdf (accessed August 2012).
-
(2010)
RL34045
-
-
Johnson, J.A.1
-
41
-
-
79952749322
-
Biosimilar agents in oncology/haemotology: From approval to practice
-
Niederwieser D, Schmitz S: Biosimilar agents in oncology/haemotology: from approval to practice. Eur J Haematol 2011;4:277-288.
-
(2011)
Eur J Haematol
, vol.4
, pp. 277-288
-
-
Niederwieser, D.1
Schmitz, S.2
-
43
-
-
84881418588
-
Global regulatory standards for the approval of biosimilars
-
Mounho B, Phillips A, Holcombe K, Grampp G, Lubiniecki T, Mollerup I, Jones C: Global regulatory standards for the approval of biosimilars. Food Drug Law J 2010;65:819-837.
-
(2010)
Food Drug Law J
, vol.65
, pp. 819-837
-
-
Mounho, B.1
Phillips, A.2
Holcombe, K.3
Grampp, G.4
Lubiniecki, T.5
Mollerup, I.6
Jones, C.7
-
44
-
-
80051570290
-
Biosimilar peptides: Need for pharmacovigilance
-
Joshi SR: Biosimilar peptides: need for pharmacovigilance. J Assoc Physicians India 2011;59(Suppl):44-47.
-
(2011)
J Assoc Physicians India
, vol.59
, Issue.SUPPL.
, pp. 44-47
-
-
Joshi, S.R.1
-
45
-
-
84876191559
-
No drug side effects reports india
-
(accesssed August 2012)
-
Shrivastava B: No drug side effects, reports India. OneWorld South Asia. 2008. http://southasia.oneworld.net/today sheadlines/no-drug-side-effects- reports-india/?searchterm = adverse drug reactions (accesssed August 2012).
-
(2008)
OneWorld South Asia
-
-
Shrivastava, B.1
|