-
1
-
-
84925221941
-
Biosimilars: The need, the challenge, the future: The FDA perspective
-
M.S. Epstein, E.D. Ehrenpreis, and P.M. Kulkarni Biosimilars: the need, the challenge, the future: the FDA perspective Am J Gastroenterol 109 2014 1856 1859
-
(2014)
Am J Gastroenterol
, vol.109
, pp. 1856-1859
-
-
Epstein, M.S.1
Ehrenpreis, E.D.2
Kulkarni, P.M.3
-
2
-
-
84969691858
-
FDA advisers recommend approval of filgrastim biosimilar
-
GaBI Online - Generics and Biosimilars Initiative
-
GaBI Online - Generics and Biosimilars Initiative. FDA advisers recommend approval of filgrastim biosimilar. Mol: Pro Pharma Communications International. 2015;2015.
-
(2015)
Mol: Pro Pharma Communications International. 2015
-
-
-
3
-
-
80054922640
-
NCCN Biosimilars White Paper: Regulatory, scientific, and patient safety perspectives
-
A.D. Zelenetz, I. Ahmed, E.L. Braud, and et al. NCCN Biosimilars White Paper: regulatory, scientific, and patient safety perspectives J Natl Compr Cancer Netw 9 Suppl 4 2011 S1 22
-
(2011)
J Natl Compr Cancer Netw
, vol.9
, pp. S1-22
-
-
Zelenetz, A.D.1
Ahmed, I.2
Braud, E.L.3
-
4
-
-
79952749322
-
Biosimilar agents in oncology/haematology: From approval to practice
-
D. Niederwieser, and S. Schmitz Biosimilar agents in oncology/haematology: from approval to practice Eur J Haematol 86 2011 277 288
-
(2011)
Eur J Haematol
, vol.86
, pp. 277-288
-
-
Niederwieser, D.1
Schmitz, S.2
-
5
-
-
84894590924
-
Biosimilar safety considerations in clinical practice
-
E. Choy, and I.A. Jacobs Biosimilar safety considerations in clinical practice Semin Oncol 41 Suppl 1 2014 S3 14
-
(2014)
Semin Oncol
, vol.41
, pp. S3-14
-
-
Choy, E.1
Jacobs, I.A.2
-
6
-
-
84900459730
-
Biosimilars in the therapy of inflammatory bowel diseases
-
T. Hlavaty, and J. Letkovsky Biosimilars in the therapy of inflammatory bowel diseases Eur J Gastroenterol Hepatol 26 2014 581 587
-
(2014)
Eur J Gastroenterol Hepatol
, vol.26
, pp. 581-587
-
-
Hlavaty, T.1
Letkovsky, J.2
-
7
-
-
78049362302
-
-
World Health Organisation WHO Expert Committee on Biological Standardization, Sixtieth report (19-23 October 2009) WHO Technical Report Series No. 977, 2013 - Annex 2 2013
-
World Health Organisation. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). WHO Expert Committee on Biological Standardization, Sixtieth report (19-23 October 2009) WHO Technical Report Series No. 977, 2013 - Annex 2 2013.
-
Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)
-
-
-
8
-
-
84937913360
-
Challenges in global biosimilar development: A regulatory perspective
-
P. Hurley, J. Boren, and C. Congiatu Challenges in global biosimilar development: A regulatory perspective Contract Pharma 2015
-
(2015)
Contract Pharma
-
-
Hurley, P.1
Boren, J.2
Congiatu, C.3
-
10
-
-
84966283006
-
-
European Medicines Agency EMA/CHMP/437/04 Rev 1. Committee for Medicinal Products for Human Use (CHMP)
-
European Medicines Agency. Guideline on similar biological medicinal products. EMA/CHMP/437/04 Rev 1. Committee for Medicinal Products for Human Use (CHMP). 2014.
-
(2014)
Guideline on Similar Biological Medicinal Products
-
-
-
11
-
-
84969690690
-
-
International Conference on Harmonisation (ICH) Comparability of biotechnological/biological products subject to changes in their manufacturing process. Q5E
-
International Conference on Harmonisation (ICH). ICH Harmonised Tripartite Guideline. Comparability of biotechnological/biological products subject to changes in their manufacturing process. Q5E. 2004.
-
(2004)
ICH Harmonised Tripartite Guideline
-
-
-
12
-
-
84884901120
-
Epoetin biosimilars in Europe: Five years on
-
A. Mikhail, and M. Farouk Epoetin biosimilars in Europe: five years on Adv Ther 30 2013 28 40
-
(2013)
Adv Ther
, vol.30
, pp. 28-40
-
-
Mikhail, A.1
Farouk, M.2
-
13
-
-
84901920947
-
A review of CT-P13: An infliximab biosimilar
-
K. McKeage A review of CT-P13: an infliximab biosimilar BioDrugs 28 2014 313 321
-
(2014)
BioDrugs
, vol.28
, pp. 313-321
-
-
McKeage, K.1
-
14
-
-
84899132159
-
Epoetin zeta in the management of anemia associated with chronic kidney disease, differential pharmacology and clinical utility
-
M.L. Davis-Ajami, J. Wu, K. Downton, and et al. Epoetin zeta in the management of anemia associated with chronic kidney disease, differential pharmacology and clinical utility Biologics 8 2014 155 167
-
(2014)
Biologics
, vol.8
, pp. 155-167
-
-
Davis-Ajami, M.L.1
Wu, J.2
Downton, K.3
-
15
-
-
84896130442
-
-
European Medicines Agency (EMA) EPAR Scientific Discussion
-
European Medicines Agency (EMA). Epoetin alfa Hexal. EPAR Scientific Discussion. 2007.
-
(2007)
Epoetin Alfa Hexal
-
-
-
16
-
-
84969691592
-
-
European Medicines Agency (EMA) EPAR Scientific Discussion
-
European Medicines Agency (EMA). Retacrit. EPAR Scientific Discussion. 2007.
-
(2007)
Retacrit
-
-
-
17
-
-
84959520896
-
-
European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP)
-
European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Assessment report: Inflectra (infliximab). 2013.
-
(2013)
Assessment Report: Inflectra (Infliximab)
-
-
-
18
-
-
67650067226
-
Bioequivalence of HX575 (recombinant human epoetin alfa) and a comparator epoetin alfa after multiple intravenous administrations: An open-label randomised controlled trial
-
F. Sorgel, U. Thyroff-Friesinger, A. Vetter, and et al. Bioequivalence of HX575 (recombinant human epoetin alfa) and a comparator epoetin alfa after multiple intravenous administrations: an open-label randomised controlled trial BMC Clin Pharmacol 9 2009 10
-
(2009)
BMC Clin Pharmacol
, vol.9
, pp. 10
-
-
Sorgel, F.1
Thyroff-Friesinger, U.2
Vetter, A.3
-
19
-
-
44849097160
-
Evaluation of the pharmacokinetics of two recombinant human erythropoietin preparations: Epoetin zeta and epoetin alfa. 1st Communication: A monocentric, open, randomized, single dose, two-period crossover trial in healthy volunteers
-
V. Kirkov, V. Dimitrova, M. Siebert-Weigel, and et al. Evaluation of the pharmacokinetics of two recombinant human erythropoietin preparations: epoetin zeta and epoetin alfa. 1st Communication: A monocentric, open, randomized, single dose, two-period crossover trial in healthy volunteers Arzneimittelforschung 58 2008 215 219
-
(2008)
Arzneimittelforschung
, vol.58
, pp. 215-219
-
-
Kirkov, V.1
Dimitrova, V.2
Siebert-Weigel, M.3
-
20
-
-
44849143713
-
Evaluation of the pharmacokinetics of two recombinant human erythropoietin preparations: Epoetin zeta and epoetin alfa. 2nd Communication: A monocentric, double-blind, randomized, single dose, three-period crossover trial in healthy volunteers
-
V. Kirkov, V. Dimitrova, M. Siebert-Weigel, and et al. Evaluation of the pharmacokinetics of two recombinant human erythropoietin preparations: epoetin zeta and epoetin alfa. 2nd Communication: A monocentric, double-blind, randomized, single dose, three-period crossover trial in healthy volunteers Arzneimittelforschung 58 2008 220 224
-
(2008)
Arzneimittelforschung
, vol.58
, pp. 220-224
-
-
Kirkov, V.1
Dimitrova, V.2
Siebert-Weigel, M.3
-
21
-
-
70350776252
-
Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis
-
M. Haag-Weber, A. Vetter, and U. Thyroff-Friesinger Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis Clin Nephrol 72 2009 380 390
-
(2009)
Clin Nephrol
, vol.72
, pp. 380-390
-
-
Haag-Weber, M.1
Vetter, A.2
Thyroff-Friesinger, U.3
-
22
-
-
44349139462
-
Comparison of the therapeutic effects of epoetin zeta and epoetin alpha in the correction of renal anaemia
-
S. Krivoshiev, V.V. Todorov, J. Manitius, and et al. Comparison of the therapeutic effects of epoetin zeta and epoetin alpha in the correction of renal anaemia Curr Med Res Opin 24 2008 1407 1415
-
(2008)
Curr Med Res Opin
, vol.24
, pp. 1407-1415
-
-
Krivoshiev, S.1
Todorov, V.V.2
Manitius, J.3
-
23
-
-
41149131276
-
Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment
-
V. Wizemann, B. Rutkowski, C. Baldamus, and et al. Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment Curr Med Res Opin 24 2008 625 637
-
(2008)
Curr Med Res Opin
, vol.24
, pp. 625-637
-
-
Wizemann, V.1
Rutkowski, B.2
Baldamus, C.3
-
24
-
-
84883746909
-
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
-
W. Park, P. Hrycaj, S. Jeka, and 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 72 2013 1605 1612
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 1605-1612
-
-
Park, W.1
Hrycaj, P.2
Jeka, S.3
-
25
-
-
84883752718
-
A randomised, double-blind, parallel-group 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
-
D.H. Yoo, P. Hrycaj, P. Miranda, and et al. A randomised, double-blind, parallel-group 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 72 2013 1613 1620
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 1613-1620
-
-
Yoo, D.H.1
Hrycaj, P.2
Miranda, P.3
-
26
-
-
84922611724
-
Biopharmaceuticals for rheumatic diseases in Latin America, Europe, Russia, and India: Innovators, biosimilars, and intended copies
-
G. Castaneda-Hernandez, Z. Szekanecz, E. Mysler, and et al. Biopharmaceuticals for rheumatic diseases in Latin America, Europe, Russia, and India: Innovators, biosimilars, and intended copies Joint Bone Spine 81 2014 471 477
-
(2014)
Joint Bone Spine
, vol.81
, pp. 471-477
-
-
Castaneda-Hernandez, G.1
Szekanecz, Z.2
Mysler, E.3
-
27
-
-
69949150756
-
Long-term safety and tolerability of epoetin zeta, administered intravenously, for maintenance treatment of renal anemia
-
C. Baldamus, S. Krivoshiev, M. Wolf-Pflugmann, and et al. Long-term safety and tolerability of epoetin zeta, administered intravenously, for maintenance treatment of renal anemia Adv Ther 25 2008 1215 1228
-
(2008)
Adv Ther
, vol.25
, pp. 1215-1228
-
-
Baldamus, C.1
Krivoshiev, S.2
Wolf-Pflugmann, M.3
-
28
-
-
77950517325
-
The safety and side effects of monoclonal antibodies
-
T.T. Hansel, H. Kropshofer, T. Singer, and et al. The safety and side effects of monoclonal antibodies Nat Rev Drug Discov 9 2010 325 338
-
(2010)
Nat Rev Drug Discov
, vol.9
, pp. 325-338
-
-
Hansel, T.T.1
Kropshofer, H.2
Singer, T.3
-
29
-
-
84900486102
-
Optimized nonclinical safety assessment strategies supporting clinical development of therapeutic monoclonal antibodies targeting inflammatory diseases
-
F.R. Brennan, A. Cauvin, J. Tibbitts, and A. Wolfreys Optimized nonclinical safety assessment strategies supporting clinical development of therapeutic monoclonal antibodies targeting inflammatory diseases Drug Dev Res 75 2014 115 161
-
(2014)
Drug Dev Res
, vol.75
, pp. 115-161
-
-
Brennan, F.R.1
Cauvin, A.2
Tibbitts, J.3
Wolfreys, A.4
-
30
-
-
0942287103
-
Anti-erythropoietin antibodies and pure red cell aplasia
-
J. Rossert, N. Casadevall, and K.U. Eckardt Anti-erythropoietin antibodies and pure red cell aplasia J Am Soc Nephrol 15 2004 398 406
-
(2004)
J Am Soc Nephrol
, vol.15
, pp. 398-406
-
-
Rossert, J.1
Casadevall, N.2
Eckardt, K.U.3
-
31
-
-
77957723026
-
Biosimilar epoetins and other "follow-on" biologics: Update on the European experiences
-
W. Jelkmann Biosimilar epoetins and other "follow-on" biologics: update on the European experiences Am J Hematol 85 2010 771 780
-
(2010)
Am J Hematol
, vol.85
, pp. 771-780
-
-
Jelkmann, W.1
-
34
-
-
84904069611
-
The challenge of indication extrapolation for infliximab biosimilars
-
B.G. Feagan, D. Choquette, S. Ghosh, and et al. The challenge of indication extrapolation for infliximab biosimilars Biologicals 42 2014 177 183
-
(2014)
Biologicals
, vol.42
, pp. 177-183
-
-
Feagan, B.G.1
Choquette, D.2
Ghosh, S.3
-
35
-
-
84893044719
-
Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars?
-
H. Lee Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars? AAPS J 16 2014 22 26
-
(2014)
AAPS J
, vol.16
, pp. 22-26
-
-
Lee, H.1
-
36
-
-
84889688016
-
Inequities in access to biologic and synthetic DMARDs across 46 European countries
-
P. Putrik, S. Ramiro, T.K. Kvien, and et al. Inequities in access to biologic and synthetic DMARDs across 46 European countries Ann Rheum Dis 73 2014 198 206
-
(2014)
Ann Rheum Dis
, vol.73
, pp. 198-206
-
-
Putrik, P.1
Ramiro, S.2
Kvien, T.K.3
-
37
-
-
84929610400
-
Viewpoint: Knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn's and Colitis Organization
-
S. Danese, G. Fiorino, and P. Michetti Viewpoint: knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn's and Colitis Organization J Crohns Colitis 8 2014 1548 1550
-
(2014)
J Crohns Colitis
, vol.8
, pp. 1548-1550
-
-
Danese, S.1
Fiorino, G.2
Michetti, P.3
-
38
-
-
84913533583
-
Physicochemical characterization of Remsima
-
S.K. Jung, K.H. Lee, J.W. Jeon, and et al. Physicochemical characterization of Remsima MAbs 6 2014 1163 1177
-
(2014)
MAbs
, vol.6
, pp. 1163-1177
-
-
Jung, S.K.1
Lee, K.H.2
Jeon, J.W.3
-
39
-
-
84969616456
-
-
Yoon Suk J, Park DI, Kim YH, etal. Efficacy and safety of infliximab's biosimilar (REMSIMA)for IBD, 2015, Poster no. 540.
-
Efficacy and Safety of Infliximab's Biosimilar (REMSIMA)for IBD, 2015, Poster No. 540
-
-
Yoon Suk, J.1
Park, D.I.2
Kim, Y.H.3
-
41
-
-
84901680637
-
Biosimilar granulocyte colony-stimulating factor uptakes in the EU-5 markets: A descriptive analysis
-
F. Bocquet, P. Paubel, I. Fusier, and et al. Biosimilar granulocyte colony-stimulating factor uptakes in the EU-5 markets: a descriptive analysis Appl Health Econ Health Policy 12 2014 315 326
-
(2014)
Appl Health Econ Health Policy
, vol.12
, pp. 315-326
-
-
Bocquet, F.1
Paubel, P.2
Fusier, I.3
-
42
-
-
84880421358
-
A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anaemia in haemodialysis patients: Background and methodology of the MONITOR-CKD5 study
-
L. Gesualdo, G. London, M. Turner, and et al. A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anaemia in haemodialysis patients: background and methodology of the MONITOR-CKD5 study Intern Emerg Med 8 2013 389 399
-
(2013)
Intern Emerg Med
, vol.8
, pp. 389-399
-
-
Gesualdo, L.1
London, G.2
Turner, M.3
-
43
-
-
84925223869
-
Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: A network meta-analysis
-
CD010590
-
S.C. Palmer, V. Saglimbene, D. Mavridis, and et al. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis Cochrane Database Syst Rev 12 2014 CD010590
-
(2014)
Cochrane Database Syst Rev
, vol.12
-
-
Palmer, S.C.1
Saglimbene, V.2
Mavridis, D.3
-
44
-
-
84901049498
-
Anaphylaxis and hypotension after administration of peginesatide
-
C.L. Bennett, S. Jacob, J. Hymes, and et al. Anaphylaxis and hypotension after administration of peginesatide N Engl J Med 370 2014 2055 2056
-
(2014)
N Engl J Med
, vol.370
, pp. 2055-2056
-
-
Bennett, C.L.1
Jacob, S.2
Hymes, J.3
-
45
-
-
84899412968
-
Biosimilars in oncology: From development to clinical practice
-
K.H. Rak Tkaczuk, and I.A. Jacobs Biosimilars in oncology: from development to clinical practice Semin Oncol 41 Suppl 3 2014 S3 S12
-
(2014)
Semin Oncol
, vol.41
, pp. S3-S12
-
-
Rak Tkaczuk, K.H.1
Jacobs, I.A.2
-
46
-
-
84928107043
-
Barriers to the Use of Trastuzumab for HER2+ Breast Cancer and the Potential Impact of Biosimilars: A Physician Survey in the United States and Emerging Markets
-
P. Lammers, C. Criscitiello, G. Curigliano, and I. Jacobs Barriers to the Use of Trastuzumab for HER2+ Breast Cancer and the Potential Impact of Biosimilars: A Physician Survey in the United States and Emerging Markets Pharmaceuticals 7 2014 943 953
-
(2014)
Pharmaceuticals
, vol.7
, pp. 943-953
-
-
Lammers, P.1
Criscitiello, C.2
Curigliano, G.3
Jacobs, I.4
-
47
-
-
84905369715
-
BiOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology: Results of the ORHEO observational study
-
M. Michallet, E. Luporsi, P. Soubeyran, and et al. BiOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology: results of the ORHEO observational study BMC Cancer 14 2014 503
-
(2014)
BMC Cancer
, vol.14
, pp. 503
-
-
Michallet, M.1
Luporsi, E.2
Soubeyran, P.3
-
48
-
-
79952172080
-
Background and methodology of MONITOR-GCSF, a pharmaco-epidemiological study of the multi-level determinants, predictors, and clinical outcomes of febrile neutropenia prophylaxis with biosimilar granulocyte-colony stimulating factor filgrastim
-
P. Gascon, M. Aapro, H. Ludwig, and et al. Background and methodology of MONITOR-GCSF, a pharmaco-epidemiological study of the multi-level determinants, predictors, and clinical outcomes of febrile neutropenia prophylaxis with biosimilar granulocyte-colony stimulating factor filgrastim Crit Rev Oncol Hematol 77 2011 184 197
-
(2011)
Crit Rev Oncol Hematol
, vol.77
, pp. 184-197
-
-
Gascon, P.1
Aapro, M.2
Ludwig, H.3
-
49
-
-
84969744441
-
Assessing biosimilar uptake and competition in European markets
-
IMS Institute for Healthcare Informatics Accessed
-
IMS Institute for Healthcare Informatics. Assessing biosimilar uptake and competition in European markets. IMS Report. 2014. https://www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs/Assessing-biosimilar-uptake-and-competition-in-European-markets.pdf. Accessed
-
(2014)
IMS Report
-
-
-
51
-
-
84897519722
-
Pharmacology of biosimilar candidate drugs in rheumatology: A literature review
-
F. Araujo, I. Cordeiro, F. Teixeira, and et al. Pharmacology of biosimilar candidate drugs in rheumatology: a literature review Acta Reumatol Port 39 2014 19 26
-
(2014)
Acta Reumatol Port
, vol.39
, pp. 19-26
-
-
Araujo, F.1
Cordeiro, I.2
Teixeira, F.3
-
52
-
-
84898853424
-
The use of biosimilars in immune-mediated disease: A joint Italian Society of Rheumatology (SIR), Italian Society of Dermatology (SIDeMaST), and Italian Group of Inflammatory Bowel Disease (IG-IBD) position paper
-
G. Fiorino, G. Girolomoni, G. Lapadula, and et al. The use of biosimilars in immune-mediated disease: A joint Italian Society of Rheumatology (SIR), Italian Society of Dermatology (SIDeMaST), and Italian Group of Inflammatory Bowel Disease (IG-IBD) position paper Autoimmun Rev 13 2014 751 755
-
(2014)
Autoimmun Rev
, vol.13
, pp. 751-755
-
-
Fiorino, G.1
Girolomoni, G.2
Lapadula, G.3
-
53
-
-
84938739042
-
Attitudes towards subsequent entry biologics/biosimilars: A survey of Canadian rheumatologists
-
D. Grabowski, B. Henderson, D. Lam, and et al. Attitudes towards subsequent entry biologics/biosimilars: A survey of Canadian rheumatologists Clin Rheumatol 34 2015 1427 1433
-
(2015)
Clin Rheumatol
, vol.34
, pp. 1427-1433
-
-
Grabowski, D.1
Henderson, B.2
Lam, D.3
-
54
-
-
84885801024
-
Preparing for subsequent entry biologics in dermatology and rheumatology in Canada
-
K. Papp, M. Bourcier, V. Ho, and et al. Preparing for subsequent entry biologics in dermatology and rheumatology in Canada J Cutan Med Surg 17 2013 340 346
-
(2013)
J Cutan Med Surg
, vol.17
, pp. 340-346
-
-
Papp, K.1
Bourcier, M.2
Ho, V.3
-
55
-
-
84901653652
-
The case for biosimilars - A payer's perspective
-
G. Befrits The case for biosimilars - a payer's perspective GaBI J 2 2013 12
-
(2013)
GaBI J
, vol.2
, pp. 12
-
-
Befrits, G.1
-
56
-
-
84928697819
-
Treatment of moderate rheumatoid arthritis with different strategies in a health resource-limited setting: A cost-effectiveness analysis in the era of biosimilars
-
B. Wu, Y. Song, L. Leng, and et al. Treatment of moderate rheumatoid arthritis with different strategies in a health resource-limited setting: a cost-effectiveness analysis in the era of biosimilars Clin Exp Rheumatol 33 2011 20 26
-
(2011)
Clin Exp Rheumatol
, vol.33
, pp. 20-26
-
-
Wu, B.1
Song, Y.2
Leng, L.3
-
57
-
-
83755207484
-
Making changes to a biopharmaceutical manufacturing process during development and commercial manufacturing: The REMICADE® story
-
A.A. Shukka, M.R. Etzel, S. Gadam, Taylor & FrancisGroup Boca Raton, Florida
-
P.W. Wojciechowski, H.I. Smit, M.M. Myers, and et al. Making changes to a biopharmaceutical manufacturing process during development and commercial manufacturing: The REMICADE® story A.A. Shukka, M.R. Etzel, S. Gadam, Process scale bioseparations for the biopharmaceutical industry 2007 Taylor & FrancisGroup Boca Raton, Florida 507 522
-
(2007)
Process Scale Bioseparations for the Biopharmaceutical Industry
, pp. 507-522
-
-
Wojciechowski, P.W.1
Smit, H.I.2
Myers, M.M.3
-
58
-
-
84913526392
-
-
GaBI Online Accessed December 11, 2014
-
GaBI Online. Biosimilars approved in Europe. 2011. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe. Accessed December 11, 2014
-
(2011)
Biosimilars Approved in Europe
-
-
-
60
-
-
84942234810
-
Scientific considerations in demonstrating biosimilarity to a reference product
-
Food and Drug Administration
-
Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. 2015. http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf.
-
(2015)
Guidance for Industry
-
-
|