-
1
-
-
84871808597
-
Generic medicines: Essential contributors to the long-term health of society - sector sustainability challenges in Europe
-
Accessed 27 Nov 2012
-
Generic medicines: essential contributors to the long-term health of society - sector sustainability challenges in Europe. IMS Health Report, 2010. http://www.egagenerics.com/index.php/publications/39-generic-medecines- essential-contributor. Accessed 27 Nov 2012.
-
(2010)
IMS Health Report
-
-
-
2
-
-
84885412935
-
Saving money in the European healthcare systems with biosimilars
-
Haustein R, de Millas C, Hoër A, Häussler B. Saving money in the European healthcare systems with biosimilars. Generics Biosimilars Initiat J. 2012;1(3-4):120-6.
-
(2012)
Generics Biosimilars Initiat J
, vol.1
, Issue.3-4
, pp. 120-126
-
-
Haustein, R.1
De Millas, C.2
Hoër, A.3
Häussler, B.4
-
4
-
-
84901653652
-
The case for biosimilars: A payer's perspective
-
Befrits G. The case for biosimilars: a payer's perspective. Generics Biosimilars Initiat J. 2013;2(1):12.
-
(2013)
Generics Biosimilars Initiat J
, vol.2
, Issue.1
, pp. 12
-
-
Befrits, G.1
-
5
-
-
8344222959
-
How similar 'biosimilars' need to be?
-
Schellekens H. How similar 'biosimilars' need to be? Nat Biotechnol. 2004;22(11):1357-9.
-
(2004)
Nat Biotechnol
, vol.22
, Issue.11
, pp. 1357-1359
-
-
Schellekens, H.1
-
6
-
-
84901677789
-
What you need to know about biosimilar medicinal products: Process on corporate responsibility in the field of pharmaceuticals access to medicines in Europe
-
Accessed 17 Oct 2013
-
What you need to know about biosimilar medicinal products: process on corporate responsibility in the field of pharmaceuticals access to medicines in Europe. European Commission. Consensus Information Paper, 2013. http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/ biosimilars-report-en.pdf. Accessed 17 Oct 2013.
-
(2013)
Consensus Information Paper
-
-
-
7
-
-
33745096842
-
Eprex-associated pure red cell aplasia and leachates [1]
-
DOI 10.1038/nbt0606-613, PII N0606613
-
Schellekens H, Jiscoot W. Eprex-associated pure red cell aplasia and leachates. Nat Biotechnol. 2006;24(6):613-4. (Pubitemid 43884419)
-
(2006)
Nature Biotechnology
, vol.24
, Issue.6
, pp. 613-614
-
-
Schellekens, H.1
Jiskoot, W.2
-
8
-
-
0347477301
-
Micelle-Associated Protein in Epoetin Formulations: A Risk Factor for Immunogenicity?
-
DOI 10.1023/B:PHAM.0000008034.61317.02
-
Hermeling S, Schellekens H, Crommelin DJ, et al. Micelle-associated protein in epoietin formulations: a risk factor for immunogenicity? Pharm Res. 2003;20:1903-7. (Pubitemid 38005518)
-
(2003)
Pharmaceutical Research
, vol.20
, Issue.12
, pp. 1903-1907
-
-
Hermeling, S.1
Schellekens, H.2
Crommelin, D.J.A.3
Jiskoot, W.4
-
9
-
-
14544300321
-
Directive 2004/27/EC of the European Parliament and of the Council of 31st March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use
-
Accessed 21 Nov 2012
-
Directive 2004/27/EC of the European Parliament and of the Council of 31st March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. Off J Eur Union L 136:34-57. http://eur-lex.europa.eu/en/index.htm. Accessed 21 Nov 2012.
-
Off J Eur Union L
, vol.136
, pp. 34-57
-
-
-
10
-
-
84901677790
-
Biosimilars: How much entry and price competition will result?
-
edited by Mattison N, Mestre-Ferrandiz J and Torse A, Dec. Accessed 28 Nov 2012
-
Biosimilars: How much entry and price competition will result? Office of Health Economics Report based on the proceedings of an OHE Conference held on 2 June 2009 edited by Mattison N, Mestre-Ferrandiz J and Torse A, Dec. 2010. http://www.ohe.org/publications/article/biosimilars-how-much-entry-and-price- competition-will-result-13.cfm. Accessed 28 Nov 2012.
-
(2010)
Office of Health Economics Report Based on the Proceedings of An OHE Conference Held on 2 June 2009
-
-
-
12
-
-
84881515057
-
Editorial: Health authority perspective on biosimilars
-
Godman B. Editorial: health authority perspective on biosimilars. Generics Biosimilars Initiat J. 2013;2(1):10-1.
-
(2013)
Generics Biosimilars Initiat J
, vol.2
, Issue.1
, pp. 10-11
-
-
Godman, B.1
-
13
-
-
84901683390
-
Les aspects juridiques du développement des médicaments biosimilaires
-
Bocquet F, Paubel P. Les aspects juridiques du développement des médicaments biosimilaires. Revue de Droit Sanitaire et Social. 2012;1:121-33.
-
(2012)
Revue de Droit Sanitaire et Social
, vol.1
, pp. 121-133
-
-
Bocquet, F.1
Paubel, P.2
-
14
-
-
84901677785
-
The global use of medicines: Outlook through 2016
-
July Accessed 16 Nov 2012
-
The global use of medicines: outlook through 2016. IMS Health for Healthcare Informatics Report, July 2012. http://www.imshealth.com/ deployedfiles/ims/Global/Content/Insights/ IMS%20Institute%20for%20Healthcare%20Informatics/ Global%20Use%20of%20Meds%202011/Medicines-Outlook-Through-2016-Report.pdf. Accessed 16 Nov 2012.
-
(2012)
IMS Health for Healthcare Informatics Report
-
-
-
15
-
-
84901653717
-
Biosimilars: Impact of differences with Hatch-Waxman
-
Kowalchyk K, Crowley-Weber C. Biosimilars: impact of differences with Hatch-Waxman. Pharm Pat Anal. 2013;2(1):29-37.
-
(2013)
Pharm Pat Anal
, vol.2
, Issue.1
, pp. 29-37
-
-
Kowalchyk, K.1
Crowley-Weber, C.2
-
16
-
-
84901676813
-
-
IMS Institute for Healthcare Informatics. Dec
-
IMS Institute for Healthcare Informatics. MIDAS, Dec 2010.
-
(2010)
MIDAS
-
-
-
17
-
-
78149351805
-
What's fueling the biotech engine 2009-2010
-
Aggarwal S. What's fueling the biotech engine 2009-2010. Nat Biotechnol. 2010;28(11):1165-71.
-
(2010)
Nat Biotechnol
, vol.28
, Issue.11
, pp. 1165-1171
-
-
Aggarwal, S.1
-
18
-
-
84873060542
-
-
IMS Health. La Défense: IMS Health;
-
IMS Health. MIDAS database. La Défense: IMS Health; 2012.
-
(2012)
MIDAS Database
-
-
-
20
-
-
85008251942
-
Licensing and prescribing biosimilars in Australia
-
Power DA. Licensing and prescribing biosimilars in Australia. Generics Biosimilars Initiat J. 2013;2(3):152-4.
-
(2013)
Generics Biosimilars Initiat J
, vol.2
, Issue.3
, pp. 152-154
-
-
Power, D.A.1
-
21
-
-
0008348082
-
-
European Medicines Agency (EMA), Accessed 22 Dec 2013
-
European public assessment reports. European Medicines Agency (EMA), 2013. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar- search.jsp&mid=WC0b01ac058001d124. Accessed 22 Dec 2013.
-
(2013)
European Public Assessment Reports
-
-
-
22
-
-
77953815432
-
The market for biosimilars: Evolution and policy options
-
Office of Health Economics, London Accessed 13 Oct 2013
-
Chauhan D, Towse A, Mestre-Ferrandiz J. The market for biosimilars: evolution and policy options, OHE Briefing No. 45, Office of Health Economics, London. 2008. http://www.ohe.org/publications/article/the-market-for- biosimilars-evolution-and-policy-options-35.cfm. Accessed 13 Oct 2013.
-
(2008)
OHE Briefing
, Issue.45
-
-
Chauhan, D.1
Towse, A.2
Mestre-Ferrandiz, J.3
-
24
-
-
84867252938
-
Shaping the biosimilars opportunity: A global perspective on the evolving biosimilars landscape
-
Dec Accessed 16 Oct 2012
-
Shaping the biosimilars opportunity: a global perspective on the evolving biosimilars landscape. IMS Health Whitepaper, Dec 2011. http://www.imshealth. com/ims/Global/Content/Home%20Page%20Content/IMS%20News/Biosimilars-Whitepaper. pdf. Accessed 16 Oct 2012.
-
(2011)
IMS Health Whitepaper
-
-
-
25
-
-
79959924862
-
Concerns about the use of biosimilar granulocyte colony-stimulating factors for the mobilization of stem cells in normal donors: Position of the World Marrow Donor Association
-
Shaw BE, Confer DL, Hwang WY, et al. Concerns about the use of biosimilar granulocyte colony-stimulating factors for the mobilization of stem cells in normal donors: position of the World Marrow Donor Association. Haematologica. 2011;96(7):942-7.
-
(2011)
Haematologica
, vol.96
, Issue.7
, pp. 942-947
-
-
Shaw, B.E.1
Confer, D.L.2
Hwang, W.Y.3
-
26
-
-
34547670214
-
Impact of primary prophylaxis with granulocyte colony-stimulating factor on febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: A systematic review
-
DOI 10.1200/JCO.2006.08.8823
-
Kuderer N, DaleD, Crawford J, et al. Impact of primary prophylaxis with granulocyte colony-stimulating factor or febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: a systematic review. J Clin Oncol. 2007;25:3158-67. (Pubitemid 47218066)
-
(2007)
Journal of Clinical Oncology
, vol.25
, Issue.21
, pp. 3158-3167
-
-
Kuderer, N.M.1
Dale, D.C.2
Crawford, J.3
Lyman, G.H.4
-
27
-
-
22244478069
-
Risk models for predicting chemotherapy-induced neutropenia
-
DOI 10.1634/theoncologist.10-6-427
-
Lyman GH, Lyman CH, Agboola O. Risk models for predicting chemotherapy-induced neutropenia. Oncologist. 2005;10:427-37. (Pubitemid 40993570)
-
(2005)
Oncologist
, vol.10
, Issue.6
, pp. 427-437
-
-
Lyman, G.H.1
Lyman, C.H.2
Agboola, O.3
-
28
-
-
5444230522
-
A prospective randomised evaluation of G-CSF or G-CSF plus oral antibiotics in chemotherapy-treated patients at high risk of developing febrile neutropenia
-
DOI 10.1007/s00520-004-0658-6
-
Lalami Y, Paesmans M, Aoun M, et al. A prospective randomized evaluation of G-CSF or G-CSF plus oral antibiotics in chemo-therapy-treated patients at high risk of developing febrile neutropenia. Support Care Cancer. 2004;12:725-30. (Pubitemid 39362652)
-
(2004)
Supportive Care in Cancer
, vol.12
, Issue.10
, pp. 725-730
-
-
Lalami, Y.1
Paesmans, M.2
Aoun, M.3
Munoz-Bermeo, R.4
Reuss, K.5
Cherifi, S.6
Alexopoulos, C.G.7
Klastersky, J.8
-
29
-
-
84901677783
-
-
Accessed 30 Nov 2012
-
WHO Collaborating Centre for Drug Statistics Methodology, 2009. http://www.whocc.no/ddd/definition-and-general-considera. Accessed 30 Nov 2012.
-
(2009)
-
-
-
30
-
-
23444460612
-
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
-
Accessed 23 Nov 2012
-
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Off J Eur Union L 136:1-33. http://eur-lex.europa. eu/en/index.htm. Accessed 23 Nov 2012.
-
Off J Eur Union L
, vol.136
, pp. 1-33
-
-
-
31
-
-
84901677784
-
-
Accessed 15 Nov 2012
-
WHO National Medicine Price Sources, 2010. http://www.who.int/entity/ medicines/areas/access/sources-prices/National-Medicine-Price-Sources.pdf. Accessed 15 Nov 2012.
-
(2010)
-
-
-
32
-
-
84991036547
-
-
IMS. prepared for EFPIA-EGA-EuropaBio April Accessed 7 Oct 2013
-
IMS. Biosimilar accessible market: size and biosimilar penetration, prepared for EFPIA-EGA-EuropaBio, April 2012. http://ec.europa.eu/enterprise/ sectors/healthcare/files/docs/biosimilars-imsstudy-en.pdf. Accessed 7 Oct 2013.
-
(2012)
Biosimilar Accessible Market: Size and Biosimilar Penetration
-
-
-
33
-
-
84901657389
-
-
Accessed 15 Nov 2012
-
Eurostat, Demography - National Data - Population, 2010. http://appsso.eurostat.ec.europa.eu/nui/show.do?dataset=demo-pjan&lang=fr. Accessed 15 Nov 2012.
-
(2010)
Demography - National Data - Population
-
-
-
34
-
-
84901648156
-
-
Agence nationale de sécurité du médicament et des produits de santé, [in French] Accessed 21 Dec 2013
-
Agence nationale de sécurité du médicament et des produits de santé, Répertoire des spécialités pharmaceutiques, 2013 [in French]. http://agence-prd.ansm.sante.fr/php/ecodex/ index.php. Accessed 21 Dec 2013.
-
(2013)
Répertoire des Spécialités Pharmaceutiques
-
-
-
36
-
-
84885377323
-
A European perspective on the market accessibility of biosimilars
-
Declerck P, Simoens S. A European perspective on the market accessibility of biosimilars. Biosimilars. 2012;2:33-40.
-
(2012)
Biosimilars
, vol.2
, pp. 33-40
-
-
Declerck, P.1
Simoens, S.2
-
38
-
-
78650187179
-
Effects of reference pricing in pharmaceutical markets: A review
-
Galizzi MM, Ghislandi S, Miraldo M. Effects of reference pricing in pharmaceutical markets: a review. Pharmacoeconomics. 2011;29(1):17-33.
-
(2011)
Pharmacoeconomics
, vol.29
, Issue.1
, pp. 17-33
-
-
Galizzi, M.M.1
Ghislandi, S.2
Miraldo, M.3
-
39
-
-
79959269131
-
European countries with small populations can obtain low prices for drugs: Lithuania as a case history
-
Garuolienè K, Godman B, Gulbinovic J, Wettermark B, Haycox A. European countries with small populations can obtain low prices for drugs: Lithuania as a case history. Expert Rev Pharmacoecon Outcomes Res. 2011;11(3):343-9.
-
(2011)
Expert Rev Pharmacoecon Outcomes Res
, vol.11
, Issue.3
, pp. 343-349
-
-
Garuolienè, K.1
Godman, B.2
Gulbinovic, J.3
Wettermark, B.4
Haycox, A.5
-
40
-
-
77954470167
-
Impact of European pharmaceutical price regulation on generic price competition: A review
-
Puig-Junoy J. Impact of European pharmaceutical price regulation on generic price competition: a review. Pharmacoeconomics. 2010;28(8):649-63.
-
(2010)
Pharmacoeconomics
, vol.28
, Issue.8
, pp. 649-663
-
-
Puig-Junoy, J.1
-
42
-
-
34848861325
-
The impact of generic reference pricing interventions in the statin market
-
DOI 10.1016/j.healthpol.2007.02.010, PII S0168851007000607
-
Puig-Junoy J. The impact of generic reference pricing interventions in the statin market. Health Policy. 2007;84(1):14-29. (Pubitemid 47498643)
-
(2007)
Health Policy
, vol.84
, Issue.1
, pp. 14-29
-
-
Puig-Junoy, J.1
-
43
-
-
84901677777
-
-
Accessed 22 Dec 2013
-
National Institute for Health and Care Excellence, 2013. http://www.nice.org.uk/. Accessed 22 Dec 2013.
-
(2013)
-
-
-
44
-
-
84901677778
-
-
October Accessed 22 Dec 2013
-
National Health Service Commissioning Board, October 2012. http://www.england.nhs.uk/wp-content/uploads/2012/09/towards-establishment.pdf. Accessed 22 Dec 2013.
-
(2012)
-
-
-
47
-
-
84901677771
-
Les médicaments biosimilaires - Etat des lieux
-
Sep [in French] Accessed 17 Oct 2013
-
Moreau A, Demolis P, Cavalié C. Les médicaments biosimilaires - Etat des lieux. ANSM Report, Sep 2013 [in French]. http://www.ansm.sante.fr/var/ansm-site/storage/original/application/ 6187b427efca64d2a15e496ff691158e.pdf. Accessed 17 Oct 2013.
-
(2013)
ANSM Report
-
-
Moreau, A.1
Demolis, P.2
Cavalié, C.3
-
48
-
-
84888116087
-
Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act
-
Chow S-C, Ju C. Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act. Generics Biosimilars Initiat J. 2013;2(1):20-5.
-
(2013)
Generics Biosimilars Initiat J
, vol.2
, Issue.1
, pp. 20-25
-
-
Chow, S.-C.1
Ju, C.2
-
49
-
-
84901653566
-
Biosimilar monoclonal antibodies: Challenges and opportunities in Europe
-
Laslop A. Biosimilar monoclonal antibodies: challenges and opportunities in Europe. Generics Biosimilars Initiat J. 2013;2(3):110-1.
-
(2013)
Generics Biosimilars Initiat J
, vol.2
, Issue.3
, pp. 110-111
-
-
Laslop, A.1
|