-
1
-
-
19044395847
-
Follow-on biologics: challenges of the 'next generation'
-
Schellekens H. Follow-on biologics: challenges of the 'next generation'. Nephrol Dial Transplant 2005;20:31-6.
-
(2005)
Nephrol Dial Transplant
, vol.20
, pp. 31-36
-
-
Schellekens, H.1
-
5
-
-
79952755198
-
-
European Medicines Agency. Guideline on similar biological medicinal products (CHMP/437/04). Available from.
-
European Medicines Agency. Guideline on similar biological medicinal products (CHMP/437/04). Available from.
-
-
-
-
6
-
-
36448974120
-
Biotherapeutics in the era of biosimilars: what really matters is patient safety
-
Declerck P. Biotherapeutics in the era of biosimilars: what really matters is patient safety. Drug Saf 2007;30:1087-92.
-
(2007)
Drug Saf
, vol.30
, pp. 1087-1092
-
-
Declerck, P.1
-
7
-
-
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;3:174-8.
-
(2008)
Clin J Am Soc Nephrol
, vol.3
, pp. 174-178
-
-
Schellekens, H.1
-
8
-
-
79952769834
-
-
European Medicines Agency. Questions and Answers on biosimilar medicines (similar biological medicinal products) (EMEA/74562/2006). Available from.
-
European Medicines Agency. Questions and Answers on biosimilar medicines (similar biological medicinal products) (EMEA/74562/2006). Available from.
-
-
-
-
9
-
-
48949118412
-
Biologicals in the era of biosimilars: implications for naming and prescribing
-
Declerck P. Biologicals in the era of biosimilars: implications for naming and prescribing. Eur J Hosp Pharmacy Practice 2007;13:51-3.
-
(2007)
Eur J Hosp Pharmacy Practice
, vol.13
, pp. 51-53
-
-
Declerck, P.1
-
11
-
-
79952752835
-
-
European Medicines Agency. Procedures for marketing authorisation, Notice to Applicants, ENTR/F2/BL D(2002) Rev 3.(Chapt 1) Available from.
-
European Medicines Agency. Procedures for marketing authorisation, Notice to Applicants, ENTR/F2/BL D(2002) Rev 3.(Chapt 1) Available from.
-
-
-
-
12
-
-
79952768055
-
-
European Medicines Agency. Human Medicines - EMEA Procedural Advice for Users of the Centralised Procedure for Generic/Hybrid Applications (EMEA/CHMP/225411/2006). Available from.
-
European Medicines Agency. Human Medicines - EMEA Procedural Advice for Users of the Centralised Procedure for Generic/Hybrid Applications (EMEA/CHMP/225411/2006). Available from.
-
-
-
-
13
-
-
79952764190
-
-
European Medicines Agency. Topic 5QC - Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products (CPMP/ICH/138/95 ICH - Adopted December 1995). Available from.
-
European Medicines Agency. Topic 5QC - Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products (CPMP/ICH/138/95 ICH - Adopted December 1995). Available from.
-
-
-
-
14
-
-
79952767742
-
-
European Medicines Agency. ICH Topic S6, preclinical safety evaluation of biotechnology-derived pharmaceuticals (CPMP/ICH/302/95 - Adopted March 1998). Available from.
-
European Medicines Agency. ICH Topic S6, preclinical safety evaluation of biotechnology-derived pharmaceuticals (CPMP/ICH/302/95 - Adopted March 1998). Available from.
-
-
-
-
15
-
-
79952765862
-
-
European Medicines Agency. CPMP/QWP/328/99 - development pharmaceutics for biotechnological and biological products - Annex to Note for Guidance on Development Pharmaceutics (CPMP/QWP/155/96). Available from.
-
European Medicines Agency. CPMP/QWP/328/99 - development pharmaceutics for biotechnological and biological products - Annex to Note for Guidance on Development Pharmaceutics (CPMP/QWP/155/96). Available from.
-
-
-
-
16
-
-
79952771940
-
-
European Medicines Agency. ICH Topic Q6B, Step 4 Note For Guidance on Specifications: test Procedures and Acceptance Criteria for Biotechnological/Biological Products (CPMP/ICH/365/96 - Adopted March 1999). Available from.
-
European Medicines Agency. ICH Topic Q6B, Step 4 Note For Guidance on Specifications: test Procedures and Acceptance Criteria for Biotechnological/Biological Products (CPMP/ICH/365/96 - Adopted March 1999). Available from.
-
-
-
-
17
-
-
79952745630
-
-
European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (EMEA/CHMP/BWP/49348/2005). Available from.
-
European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (EMEA/CHMP/BWP/49348/2005). Available from.
-
-
-
-
18
-
-
79952743949
-
-
European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CHMP/BMWP/42832/2005). Available from.
-
European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CHMP/BMWP/42832/2005). Available from.
-
-
-
-
19
-
-
79952741044
-
-
European Medicines Agency. Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - guidance on similar medicinal products containing - somatropin (EMEA/CHMP/BMWP/94528/2005). Available from.
-
European Medicines Agency. Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - guidance on similar medicinal products containing - somatropin (EMEA/CHMP/BMWP/94528/2005). Available from.
-
-
-
-
20
-
-
79952746643
-
-
European Medicines Agency. Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Guidance on similar medicinal products containing recombinant human soluble insulin (EMEA/CHMP/BMWP/32775/2005). Available from.
-
European Medicines Agency. Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Guidance on similar medicinal products containing recombinant human soluble insulin (EMEA/CHMP/BMWP/32775/2005). Available from.
-
-
-
-
21
-
-
79952772302
-
-
European Medicines Agency. Guideline on similar medicinal products containing recombinant interferon alpha (EMEA/CHMP/BMWP/102046/2006). Available from.
-
European Medicines Agency. Guideline on similar medicinal products containing recombinant interferon alpha (EMEA/CHMP/BMWP/102046/2006). Available from.
-
-
-
-
22
-
-
79952759573
-
-
European Medicines Agency. Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Guidance on similar medicinal products containing recombinant erythropoietins (EMEA/CHMP/BMWP/94526/2005). Available from.
-
European Medicines Agency. Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Guidance on similar medicinal products containing recombinant erythropoietins (EMEA/CHMP/BMWP/94526/2005). Available from.
-
-
-
-
23
-
-
79952775203
-
-
European Medicines Agency. Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor (EMEA/CHMP/BMWP/31329/2005). Available from.
-
European Medicines Agency. Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor (EMEA/CHMP/BMWP/31329/2005). Available from.
-
-
-
-
24
-
-
79952749766
-
-
European Medicines Agency. Guideline on similar biological medicinal products containing low-molecular-weight-heparins (EMEA/CHMP/BMWP/118264/2007). Available from.
-
European Medicines Agency. Guideline on similar biological medicinal products containing low-molecular-weight-heparins (EMEA/CHMP/BMWP/118264/2007). Available from.
-
-
-
-
25
-
-
79952758769
-
-
European Medicines Agency. European Medicines Agency - Overview Website of Current Legislation on Biosimilars. Available from.
-
European Medicines Agency. European Medicines Agency - Overview Website of Current Legislation on Biosimilars. Available from.
-
-
-
-
26
-
-
79952774647
-
-
U.S.Government. Public Law No. 111-148 (formerly H.R. 3590), the Patient Protection and Affordable Care Act, TITLE VII-IMPROVING ACCESS TO INNOVATIVE MEDICAL THERAPIES, Subtitle A-Biologics Price Competition and Innovation. Available from.
-
U.S.Government. Public Law No. 111-148 (formerly H.R. 3590), the Patient Protection and Affordable Care Act, TITLE VII-IMPROVING ACCESS TO INNOVATIVE MEDICAL THERAPIES, Subtitle A-Biologics Price Competition and Innovation. Available from.
-
-
-
-
27
-
-
79952773509
-
-
WHO. Expert Committee on Biological Standardization, Geneva, 19 to 23 October 2009. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). Available from.
-
WHO. Expert Committee on Biological Standardization, Geneva, 19 to 23 October 2009. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). Available from.
-
-
-
-
28
-
-
79952747377
-
-
WHO. Guidance on INN. Available from.
-
WHO. Guidance on INN. Available from.
-
-
-
-
29
-
-
79952771349
-
-
WHO. WHO Informal Consultation on International Nonproprietary Names (INN) Policy for Biosimilar Products. INN Working Document 07.211. Geneva, 4-5 September 2006. Available from.
-
WHO. WHO Informal Consultation on International Nonproprietary Names (INN) Policy for Biosimilar Products. INN Working Document 07.211. Geneva, 4-5 September 2006. Available from.
-
-
-
-
30
-
-
79952745823
-
-
Australian Government Department of Health and Ageing and Therapeutic Goods Administration (TGA). European Union guidelines adopted in Australia - Similar Biological Medicinal Products. Available from.
-
Australian Government Department of Health and Ageing and Therapeutic Goods Administration (TGA). European Union guidelines adopted in Australia - Similar Biological Medicinal Products. Available from.
-
-
-
-
31
-
-
55549146824
-
Biosimilars: opinion of an expert panel in the Middle East
-
Bohlega S, Al-Shammri S, Al Sharoqi I, Dahdaleh M, Gebeily S, Inshasi J, Khalifa A, Pakdaman H, Szólics M, Yamout B. Biosimilars: opinion of an expert panel in the Middle East. Curr Med Res Opin 2008;24:2897-903.
-
(2008)
Curr Med Res Opin
, vol.24
, pp. 2897-2903
-
-
Bohlega, S.1
Al-Shammri, S.2
Al Sharoqi, I.3
Dahdaleh, M.4
Gebeily, S.5
Inshasi, J.6
Khalifa, A.7
Pakdaman, H.8
Szólics, M.9
Yamout, B.10
-
32
-
-
79952768566
-
-
Health Canada. Guidance for Sponsors: Information and submission requirements for subsequent entry biologics (SEBs). Available from.
-
Health Canada. Guidance for Sponsors: Information and submission requirements for subsequent entry biologics (SEBs). Available from.
-
-
-
-
33
-
-
79952770031
-
-
Health Canada. Questions & Answers To Accompany the Final Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs). Available from.
-
Health Canada. Questions & Answers To Accompany the Final Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs). Available from.
-
-
-
-
34
-
-
79952741770
-
-
Visiongain. Biosimilars and Follow-On Biologics: Global Market Outlook, 2010-2025. Available from.
-
Visiongain. Biosimilars and Follow-On Biologics: Global Market Outlook, 2010-2025. Available from.
-
-
-
-
35
-
-
79952766802
-
-
IHS Global Insight. Japan's Ministry of Health, Labour and Welfare (MHLW) Issues Guidelines on Biosimilars Development and Regulatory Applications. Available from.
-
IHS Global Insight. Japan's Ministry of Health, Labour and Welfare (MHLW) Issues Guidelines on Biosimilars Development and Regulatory Applications. Available from.
-
-
-
-
36
-
-
79952743235
-
-
Sandoz Press Release 5 October 2009. Sandoz launches somatropin, the first-ever Japanese biosimilar, increasing access to key medicines in second largest global market. Available from.
-
Sandoz Press Release 5 October 2009. Sandoz launches somatropin, the first-ever Japanese biosimilar, increasing access to key medicines in second largest global market. Available from.
-
-
-
-
37
-
-
79952745999
-
-
European Medicines Agency. Assessment Report for epoetin zeta Retacrit. Nonproprietary Name: epoetin zeta (EMEA/H/C/872). Available from.
-
European Medicines Agency. Assessment Report for epoetin zeta Retacrit. Nonproprietary Name: epoetin zeta (EMEA/H/C/872). Available from.
-
-
-
-
38
-
-
79952750314
-
-
European Medicines Agency. Assessment Report for epoetin zeta Silapo. Nonproprietary Name: epoetin zeta (EMEA/H/C/760). Available from.
-
European Medicines Agency. Assessment Report for epoetin zeta Silapo. Nonproprietary Name: epoetin zeta (EMEA/H/C/760). Available from.
-
-
-
-
39
-
-
79952764737
-
-
European Medicines Agency. Assessment Report for epoetin alfa Abseamed. Nonproprietary Name: epoetin alfa (EMEA/H/C/727). Available from.
-
European Medicines Agency. Assessment Report for epoetin alfa Abseamed. Nonproprietary Name: epoetin alfa (EMEA/H/C/727). Available from.
-
-
-
-
40
-
-
79952762313
-
-
European Medicines Agency. Assessment Report for epoetin alfa Binocrit. Nonproprietary Name: epoetin alfa (EMEA/H/C/725). Available from.
-
European Medicines Agency. Assessment Report for epoetin alfa Binocrit. Nonproprietary Name: epoetin alfa (EMEA/H/C/725). Available from.
-
-
-
-
41
-
-
79952750487
-
-
European Medicines Agency. Assessment Report for epoetin alfa Hexal. Nonproprietary Name: epoetin alfa (EMEA/H/C/726). Available from.
-
European Medicines Agency. Assessment Report for epoetin alfa Hexal. Nonproprietary Name: epoetin alfa (EMEA/H/C/726). Available from.
-
-
-
-
42
-
-
67349221747
-
Assessing the bioequivalence of biosimilars The Retacrit case
-
Schellekens H. Assessing the bioequivalence of biosimilars The Retacrit case. Drug Discov Today 2009;14:495-9.
-
(2009)
Drug Discov Today
, vol.14
, pp. 495-499
-
-
Schellekens, H.1
-
43
-
-
79952748850
-
-
European Medicines Agency. Assessment Report for Tevagrastim. Nonproprietary Name: filgrastim (EMEA/H/C/827). Available from.
-
European Medicines Agency. Assessment Report for Tevagrastim. Nonproprietary Name: filgrastim (EMEA/H/C/827). Available from.
-
-
-
-
44
-
-
79952762915
-
-
European Medicines Agency. Assessment Report for Ratiograstim. Nonproprietary Name: filgrastim (EMEA/H/C/825). Available from.
-
European Medicines Agency. Assessment Report for Ratiograstim. Nonproprietary Name: filgrastim (EMEA/H/C/825). Available from.
-
-
-
-
45
-
-
79952761810
-
-
European Medicines Agency. Assessment Report for Biograstim. Nonproprietary Name: filgrastim (EMEA/H/C/826). Available from.
-
European Medicines Agency. Assessment Report for Biograstim. Nonproprietary Name: filgrastim (EMEA/H/C/826). Available from.
-
-
-
-
46
-
-
79952763991
-
-
European Medicines Agency. Assessment Report for Filgrastim ratiopharm. Nonproprietary Name: filgrastim (EMEA/H/C/824). Available from.
-
European Medicines Agency. Assessment Report for Filgrastim ratiopharm. Nonproprietary Name: filgrastim (EMEA/H/C/824). Available from.
-
-
-
-
47
-
-
79952749211
-
-
European Medicines Agency. CHMP Assessment Report for Zarzio. International Nonproprietary Name: filgrastim (EMEA/H/C/000917). Available from.
-
European Medicines Agency. CHMP Assessment Report for Zarzio. International Nonproprietary Name: filgrastim (EMEA/H/C/000917). Available from.
-
-
-
-
48
-
-
79952741216
-
-
European Medicines Agency. CHMP Assessment Report for Filgrastim Hexal. International Nonproprietary Name: filgrastim (EMEA/H/C/918). Available from.
-
European Medicines Agency. CHMP Assessment Report for Filgrastim Hexal. International Nonproprietary Name: filgrastim (EMEA/H/C/918). Available from.
-
-
-
-
49
-
-
79952745073
-
-
European Medicines Agency. Assessment Report for Nivestim. Nonproprietary Name: filgrastim (EMEA/H/C/001142). Available from.
-
European Medicines Agency. Assessment Report for Nivestim. Nonproprietary Name: filgrastim (EMEA/H/C/001142). Available from.
-
-
-
-
50
-
-
79952744905
-
-
Amgen Inc. Data on file
-
Amgen Inc. Data on file, 2009.
-
(2009)
-
-
-
51
-
-
79952743420
-
-
® Summary of Product Characteristics. Available from.
-
® Summary of Product Characteristics. Available from.
-
-
-
-
52
-
-
33748974393
-
EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphomas and solid tumours
-
Aapro MS, Cameron DA, Pettengell R, et al. EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphomas and solid tumours. Eur J Cancer 2006;42:2433-53.
-
(2006)
Eur J Cancer
, vol.42
, pp. 2433-2453
-
-
Aapro, M.S.1
Cameron, D.A.2
Pettengell, R.3
-
53
-
-
0027269718
-
A randomized controlled phase III trial of recombinant human granulocyte colony-stimulating factor (filgrastim) for treatment of severe chronic neutropenia
-
Dale DC, Bonilla MA, Davis MW, et al. A randomized controlled phase III trial of recombinant human granulocyte colony-stimulating factor (filgrastim) for treatment of severe chronic neutropenia. Blood 1993;81:2496-502.
-
(1993)
Blood
, vol.81
, pp. 2496-2502
-
-
Dale, D.C.1
Bonilla, M.A.2
Davis, M.W.3
-
54
-
-
33749478463
-
The Severe Chronic Neutropenia International Registry: 10-Year Follow-up Report
-
Dale DC, Bolyard AA, Schwinzer BG, et al. The Severe Chronic Neutropenia International Registry: 10-Year Follow-up Report. Support Cancer Ther 2006;3:220-31.
-
(2006)
Support Cancer Ther
, vol.3
, pp. 220-231
-
-
Dale, D.C.1
Bolyard, A.A.2
Schwinzer, B.G.3
-
55
-
-
19044374719
-
Biosimilar epoetins: how similar are they?
-
Schellekens H. Biosimilar epoetins: how similar are they? Eur J Hosp Pharmacy 2004;3:43-7.
-
(2004)
Eur J Hosp Pharmacy
, vol.3
, pp. 43-47
-
-
Schellekens, H.1
-
56
-
-
79952748849
-
Feature on biopharmaceuticals: Views from the pharmaceutical industry - significant questions relating to efficacy and immunogenicity will remain at approval
-
Sheridan B, Fox A. Feature on biopharmaceuticals: Views from the pharmaceutical industry - significant questions relating to efficacy and immunogenicity will remain at approval. Eur J Hosp Pharmacy Practice 2007;13:70-3.
-
(2007)
Eur J Hosp Pharmacy Practice
, vol.13
, pp. 70-73
-
-
Sheridan, B.1
Fox, A.2
-
57
-
-
79952743593
-
-
European Group for Blood and Marrow Transplantation (EBMT). Position statement: biosimilar granulocyte-colony stimulating factor (G-CSF) for stem cell mobilization in related and unrelated donors. Available from.
-
European Group for Blood and Marrow Transplantation (EBMT). Position statement: biosimilar granulocyte-colony stimulating factor (G-CSF) for stem cell mobilization in related and unrelated donors. Available from.
-
-
-
-
58
-
-
79952756376
-
Biologicals, biosimilars, drug substitution: a mandatory sequence?
-
Sitte HH. Biologicals, biosimilars, drug substitution: a mandatory sequence? Eur J Hosp Pharmacy Practice 2007;13:49-51.
-
(2007)
Eur J Hosp Pharmacy Practice
, vol.13
, pp. 49-51
-
-
Sitte, H.H.1
-
59
-
-
79952749378
-
-
Health Canada. Interchangeability/Substitutability of Subsequent Entry Biologics (SEBs) - Letter to Provincial/Territorial Drug Plan Directors July 29 2010.
-
Health Canada. Interchangeability/Substitutability of Subsequent Entry Biologics (SEBs) - Letter to Provincial/Territorial Drug Plan Directors July 29 2010.
-
-
-
-
60
-
-
79952760162
-
-
European Medicines Agency. Summary of Product Characteristics - Retacrit 07/01/2009 Retacrit-H-C-872-II-16. Available from.
-
European Medicines Agency. Summary of Product Characteristics - Retacrit 07/01/2009 Retacrit-H-C-872-II-16. Available from.
-
-
-
-
61
-
-
79952750908
-
-
European Medicines Agency. Summary of Product Characteristics - Abseamed. 20/01/2010 Abseamed-H-C-727-II-18. Available from.
-
European Medicines Agency. Summary of Product Characteristics - Abseamed. 20/01/2010 Abseamed-H-C-727-II-18. Available from.
-
-
-
-
62
-
-
79952761809
-
-
European Medicines Agency. Summary of Product Characteristics - Binocrit. 20/01/2010 Binocrit-H-C-725-II-18. Available from.
-
European Medicines Agency. Summary of Product Characteristics - Binocrit. 20/01/2010 Binocrit-H-C-725-II-18. Available from.
-
-
-
-
63
-
-
79952766437
-
-
European Medicines Agency. Summary of Product Characteristics - Epoetin alfa Hexal. 20/01/2010 Epoetin alfa Hexal-H-C-726-II-18. Available from.
-
European Medicines Agency. Summary of Product Characteristics - Epoetin alfa Hexal. 20/01/2010 Epoetin alfa Hexal-H-C-726-II-18. Available from.
-
-
-
-
64
-
-
79952763990
-
-
European Medicines Agency. Summary of Product Characteristics - Silapo.16/12/2009 Silapo-H-C-760-II-15. Available from.
-
European Medicines Agency. Summary of Product Characteristics - Silapo.16/12/2009 Silapo-H-C-760-II-15. Available from.
-
-
-
-
65
-
-
79952743052
-
-
European Medicines Agency. Summary of Product Characteristics - Ratiograstim. 06/10/2009 Ratiograstim-H-C-825-IA-05. Available from.
-
European Medicines Agency. Summary of Product Characteristics - Ratiograstim. 06/10/2009 Ratiograstim-H-C-825-IA-05. Available from.
-
-
-
-
66
-
-
79952761441
-
-
European Medicines Agency. Summary of Product Characteristics - Tevagrastim. Tevagrastim-H-C-827-II-04. Available from.
-
European Medicines Agency. Summary of Product Characteristics - Tevagrastim. Tevagrastim-H-C-827-II-04. Available from.
-
-
-
-
67
-
-
79952762312
-
-
European Medicines Agency. Summary of Product Characteristics - Filgrastim Hexal. 21/10/2009 Filgrastim Hexal-H-C-918-II-02. Available from.
-
European Medicines Agency. Summary of Product Characteristics - Filgrastim Hexal. 21/10/2009 Filgrastim Hexal-H-C-918-II-02. Available from.
-
-
-
-
68
-
-
79952741043
-
-
European Medicines Agency. Summary of Product Characteristics - Filgrastim ratiopharm. 15/09/2008 Filgrastim ratiopharm-H-C-824-00-00. Available from.
-
European Medicines Agency. Summary of Product Characteristics - Filgrastim ratiopharm. 15/09/2008 Filgrastim ratiopharm-H-C-824-00-00. Available from.
-
-
-
-
69
-
-
79952742870
-
-
European Medicines Agency. Summary of Product Characteristics - Biograstim. 06/10/2009 Biograstim-H-C-826-IA-03. Available from.
-
European Medicines Agency. Summary of Product Characteristics - Biograstim. 06/10/2009 Biograstim-H-C-826-IA-03. Available from.
-
-
-
-
70
-
-
79952752834
-
-
European Medicines Agency. Summary of Product Characteristics - Zarzio. Zarzio-H-C-917-II-02. Available from.
-
European Medicines Agency. Summary of Product Characteristics - Zarzio. Zarzio-H-C-917-II-02. Available from.
-
-
-
-
71
-
-
79952767876
-
-
European Medicines Agency. Summary of Product Characteristics - Nivestim. Nivestim EMEA/H/C/001142. Available from.
-
European Medicines Agency. Summary of Product Characteristics - Nivestim. Nivestim EMEA/H/C/001142. Available from.
-
-
-
-
73
-
-
33748685217
-
Comparative testing and pharmacovigilance of biosimilars
-
Locatelli F, Roger S. Comparative testing and pharmacovigilance of biosimilars. Nephrol Dial Transplant 2006;21:v13-6.
-
(2006)
Nephrol Dial Transplant
, vol.21
-
-
Locatelli, F.1
Roger, S.2
-
74
-
-
79952761267
-
-
Medicines and Healthcare products Regulatory Agency (MHRA). Drugs under intensive surveillance (Black Triangle List) - September 2010. Available from.
-
Medicines and Healthcare products Regulatory Agency (MHRA). Drugs under intensive surveillance (Black Triangle List) - September 2010. Available from.
-
-
-
-
75
-
-
79952769326
-
-
French Gazette. LOI no 2006-3062 du 3 mai 2006. Projet de loi portant diverses dispositions d'adaptation au droit communautaire dans le domaine du médicament. Available from.
-
French Gazette. LOI no 2006-3062 du 3 mai 2006. Projet de loi portant diverses dispositions d'adaptation au droit communautaire dans le domaine du médicament. Available from.
-
-
-
-
76
-
-
79952755373
-
-
German Bundesministerium der Justiz. German Social Law book, Aut idem'§ 129 section 4 sentence 1, January 17th 2008. Regulation Rahmenvertrag 20080117. Available from.
-
German Bundesministerium der Justiz. German Social Law book, 'Aut idem'§ 129 section 4 sentence 1, January 17th 2008. Regulation Rahmenvertrag 20080117. Available from.
-
-
-
-
77
-
-
79952756001
-
-
ND96/1973, article 13 (section 3) - Greek law on the sales of pharmaceutical products.
-
ND96/1973, article 13 (section 3) - Greek law on the sales of pharmaceutical products. 1973.
-
(1973)
-
-
-
78
-
-
79952753189
-
-
PD 340/1993 (article 23) Code of Ethics for Pharmacists in Greece.
-
PD 340/1993 (article 23) Code of Ethics for Pharmacists in Greece. 1993.
-
(1993)
-
-
-
79
-
-
79952772301
-
-
Italian Council of State Opinion. Italian Council of State Opinion n.3992.07 based on a note by the Italian Ministry of Health.
-
Italian Council of State Opinion. Italian Council of State Opinion n.3992.07 based on a note by the Italian Ministry of Health, 2007.
-
(2007)
-
-
-
80
-
-
79952761630
-
-
FIRDPC Regulation on Interchangeability, September Available from.
-
FIRDPC Regulation on Interchangeability, September 2008. Available from.
-
(2008)
-
-
-
81
-
-
79952770773
-
-
Ministerio De Sanidad Y Consumo. 17420: ORDEN SCO/2874/2007, de 28 de septiembre, por la que se establecen los medicamentos que constituyen excepción a la posible sustitución por el farmacéutico con arreglo al articulo 86.4 de la Ley 29/2006, de 26 de Julio, de garantías y uso racional de los medicamentos y productos sanitarios. (Octubre 2007) Available from.
-
Ministerio De Sanidad Y Consumo. 17420: ORDEN SCO/2874/2007, de 28 de septiembre, por la que se establecen los medicamentos que constituyen excepción a la posible sustitución por el farmacéutico con arreglo al articulo 86.4 de la Ley 29/2006, de 26 de Julio, de garantías y uso racional de los medicamentos y productos sanitarios. (Octubre 2007) Available from.
-
-
-
-
82
-
-
79952775389
-
-
Swedish Medicines Agency (MPA) statement on substitution of biologics. Available from.
-
Swedish Medicines Agency (MPA) statement on substitution of biologics. Available from.
-
-
-
-
83
-
-
79952764930
-
-
Proposal to the Department of Health's Ministerial Industry Strategy Group (MISG) on the substitution of biological medicines. Available from.
-
Proposal to the Department of Health's Ministerial Industry Strategy Group (MISG) on the substitution of biological medicines. Available from.
-
-
-
-
84
-
-
79952759572
-
-
Czech Drug Law No 378/2007, sect; 83, article 2, valid as of January 1st, 2008. 2008 Jan 1.
-
Czech Drug Law No 378/2007, § 83, article 2, valid as of January 1st, 2008. 2008 Jan 1.
-
-
-
-
85
-
-
79952751284
-
-
Danish Medicines Agency. Approved Generic Substitution List. Available from.
-
Danish Medicines Agency. Approved Generic Substitution List. Available from.
-
-
-
-
86
-
-
79952757105
-
-
Finnish Medicines Agency (FIMEA). Principles for compiling the list of mutually substitutable medicinal products with marketing authorisation at the Finnish Medicines Agency. Available from.
-
Finnish Medicines Agency (FIMEA). Principles for compiling the list of mutually substitutable medicinal products with marketing authorisation at the Finnish Medicines Agency. 2009. Available from.
-
(2009)
-
-
-
87
-
-
79952763811
-
-
OGYI- Orzagos Gyogyszerezeti Intezet (Hungarian National Institute of Pharmacy). OGYI - Helyettesíthetõségi lista. A lista lezárásának idõpontja. Nov 2009. Available from.
-
OGYI- Orzagos Gyogyszerezeti Intezet (Hungarian National Institute of Pharmacy). OGYI - Helyettesíthetõségi lista. A lista lezárásának idõpontja. Nov 2009. Available from.
-
-
-
-
88
-
-
79952770195
-
-
NOMA. Norway's Medicines Agency (NOMA) - Biotilsvarende filgrastim tas midlertidig av Byttelisten. Available from.
-
NOMA. Norway's Medicines Agency (NOMA) - Biotilsvarende filgrastim tas midlertidig av Byttelisten. Available from.
-
-
-
-
89
-
-
79952772483
-
-
NOMA. Norway's Medicines Agency (NOMA) Automatic Substitution List. 1 October 2010. Available from.
-
NOMA. Norway's Medicines Agency (NOMA) Automatic Substitution List. 1 October 2010. Available from.
-
-
-
-
90
-
-
79952773508
-
-
Slovakian Ministry of Health. Act of Slovakian Ministry of Health no. 209/2008
-
Slovakian Ministry of Health. Act of Slovakian Ministry of Health no. 209/2008, 2008.
-
(2008)
-
-
-
91
-
-
79952745821
-
-
Austrian Medical Law. ökonomische Verschreibung, RÖF 2005
-
Austrian Medical Law. ökonomische Verschreibung, RÖF 2005, 2005.
-
(2005)
-
-
-
93
-
-
34548841437
-
The same but different
-
Ledford H. The same but different. Nature 2007;449:274-6.
-
(2007)
Nature
, vol.449
, pp. 274-276
-
-
Ledford, H.1
|