-
1
-
-
84883566227
-
-
Accessed 18 February 2014
-
Biologics Price Competition and Innovation Act of 2009. 2009. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM216146.pdf. Accessed 18 February 2014.
-
(2009)
Biologics Price Competition and Innovation Act of 2009
-
-
-
2
-
-
79961116944
-
Developing the nation's biosimilars program
-
21812668 1:CAS:528:DC%2BC3MXpvFSitL8%3D
-
Kozlowski S, Woodcock J, Midthun K, Sherman RB. Developing the nation's biosimilars program. N Engl J Med. 2011;365(5):385-8.
-
(2011)
N Engl J Med.
, vol.365
, Issue.5
, pp. 385-388
-
-
Kozlowski, S.1
Woodcock, J.2
Midthun, K.3
Sherman, R.B.4
-
3
-
-
84939880482
-
-
Accessed 18 February 2014
-
European public assessment reports: biosimilars. European Medicines Agency, London, UK. 2013. http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar-search.jsp&murl=menus%2Fmedicines%2Fmedicines.jsp&mid=WC0b01ac058001d124&searchTab=searchByAuthType&alreadyLoaded=true&isNewQuery=true&status=Authorised&status=Withdrawn&status=Suspended&status=Refused&keyword=Enter+keywords&searchType=name&taxonomyPath=&treeNumber=&searchGenericType=biosimilars&genericsKeywordSearch=Submit. Accessed 18 February 2014.
-
(2013)
European Public Assessment Reports: Biosimilars. European Medicines Agency, London, UK
-
-
-
6
-
-
84880018515
-
It's all about the name: What is the imperative of adopting unique names for biologic and biosimilar therapeutics?
-
Dolinar R. It's all about the name: what is the imperative of adopting unique names for biologic and biosimilar therapeutics? Food Drug Policy Forum. 2012;2(22):1-19.
-
(2012)
Food Drug Policy Forum.
, vol.2
, Issue.22
, pp. 1-19
-
-
Dolinar, R.1
-
7
-
-
84923371006
-
Is it necessary to depart from international naming conventions for biosimilars in the US to ensure the safety of biologic and biosimilar therapeutics? A response to 'It's all about the name: What is the imperative of adopting unique names for biologic and biosimilar therapeutics?'
-
Miller S. Is it necessary to depart from international naming conventions for biosimilars in the US to ensure the safety of biologic and biosimilar therapeutics? A response to 'It's all about the name: what is the imperative of adopting unique names for biologic and biosimilar therapeutics?'. Food Drug Policy Forum. 2013;3(1):1-24.
-
(2013)
Food Drug Policy Forum.
, vol.3
, Issue.1
, pp. 1-24
-
-
Miller, S.1
-
8
-
-
84878900689
-
Pharmacovigilance and biosimilars: Considerations, needs, and challenges
-
23527621 1:CAS:528:DC%2BC3sXptFChsbY%3D
-
Casadevall N, Edwards IR, Felix T, Graze PR, Litten JB, Strober BE, et al. Pharmacovigilance and biosimilars: considerations, needs, and challenges. Expert Opin Biol Ther. 2013;13(7):1039-47.
-
(2013)
Expert Opin Biol Ther.
, vol.13
, Issue.7
, pp. 1039-1047
-
-
Casadevall, N.1
Edwards, I.R.2
Felix, T.3
Graze, P.R.4
Litten, J.B.5
Strober, B.E.6
-
10
-
-
84940734305
-
Biosimilar regulation: Important considerations and global developments
-
Accessed 18 February 2014.
-
Bogaert P, Lietzan E, Sim L. Biosimilar regulation: important considerations and global developments. In: Cross-border life sciences handbook. Practical Law Company. 2011. http://www.cov.com/files/Publication/675a60c0-58e3-41fe-82a7-48120814f04a/Presentation/PublicationAttachment/3966b7f6-690a-4380-bd70-5501df1c5e74/Biosimilar%20regulation%20-%20important%20considerations%20and%20global%20developments%20-%202011.pdf. Accessed 18 February 2014.
-
(2011)
Cross-border Life Sciences Handbook. Practical Law Company
-
-
Bogaert, P.1
Lietzan, E.2
Sim, L.3
-
11
-
-
84893870832
-
Biologic product identification and US pharmacovigilance in the biosimilars era
-
24509751 1:CAS:528:DC%2BC2cXitVemu78%3D
-
Felix T, Johansson TT, Colliatie JA, Goldberg MR, Fox AR. Biologic product identification and US pharmacovigilance in the biosimilars era. Nat Biotechnol. 2014;32(2):128-30.
-
(2014)
Nat Biotechnol.
, vol.32
, Issue.2
, pp. 128-130
-
-
Felix, T.1
Johansson, T.T.2
Colliatie, J.A.3
Goldberg, M.R.4
Fox, A.R.5
-
19
-
-
84939931167
-
-
US Food and Drug Administration Accessed 18 February 2014.
-
US Food and Drug Administration. FDA NDA 505(b)(1) of the FD&C Act. http://www.fda.gov/downloads/Drugs/NewsEvents/UCM245363.pdf. Accessed 18 February 2014.
-
FDA NDA 505(b)(1) of the FD&C Act
-
-
-
20
-
-
80052264051
-
Biosimilars: An overview
-
Sekon BS, Saluja V. Biosimilars: an overview. Biosimilars. 2011;1:1-11.
-
(2011)
Biosimilars
, vol.1
, pp. 1-11
-
-
Sekon, B.S.1
Saluja, V.2
-
24
-
-
84946029854
-
Alliance for Safe Biologic Medicines - Prescriber survey
-
Accessed 18 February 2014.
-
Olson K. Alliance for Safe Biologic Medicines - prescriber survey. Alliance for Safe Biologic Medicines. 2012. http://safebiologics.org/resources/wp-content/uploads/2012/09/ASBM-Survey-2.pdf. Accessed 18 February 2014.
-
(2012)
Alliance for Safe Biologic Medicines
-
-
Olson, K.1
-
27
-
-
84939931170
-
-
European Biopharmaceutical Enterprises Accessed 11 April 2014.
-
European Biopharmaceutical Enterprises. French biosimilar law - no generics-style substitution policy. 2014. http://www.gabionline.net/Policies-Legislation/France-to-allow-biosimilars-substitution. Accessed 11 April 2014.
-
(2014)
French Biosimilar Law - No Generics-style Substitution Policy
-
-
-
28
-
-
84867307195
-
The safety of switching between therapeutic proteins
-
22849511 1:CAS:528:DC%2BC38XhsV2ktb3L
-
Ebbers HC, Muenzberg M, Schellekens H. The safety of switching between therapeutic proteins. Expert Opin Biol Ther. 2012;12(11):1473-85.
-
(2012)
Expert Opin Biol Ther.
, vol.12
, Issue.11
, pp. 1473-1485
-
-
Ebbers, H.C.1
Muenzberg, M.2
Schellekens, H.3
-
29
-
-
84855436897
-
Safety, immunogenicity and efficacy of subcutaneous biosimilar epoetin-alpha (HX575) in non-dialysis patients with renal anemia: A multi-center, randomized, double-blind study
-
22185963 1:CAS:528:DC%2BC38Xjs1Shu7c%3D
-
Haag-Weber M, Eckardt KU, Horl WH, Roger SD, Vetter A, Roth K. Safety, immunogenicity and efficacy of subcutaneous biosimilar epoetin-alpha (HX575) in non-dialysis patients with renal anemia: a multi-center, randomized, double-blind study. Clin Nephrol. 2012;77(1):8-17.
-
(2012)
Clin Nephrol.
, vol.77
, Issue.1
, pp. 8-17
-
-
Haag-Weber, M.1
Eckardt, K.U.2
Horl, W.H.3
Roger, S.D.4
Vetter, A.5
Roth, K.6
-
30
-
-
84881122457
-
Traceability of biopharmaceuticals in spontaneous reporting systems: A cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases
-
23771794
-
Vermeer NS, Straus SM, Mantel-Teeuwisse AK, Domergue F, Egberts TC, Leufkens HG, et al. Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases. Drug Saf. 2013;36(8):617-25.
-
(2013)
Drug Saf.
, vol.36
, Issue.8
, pp. 617-625
-
-
Vermeer, N.S.1
Straus, S.M.2
Mantel-Teeuwisse, A.K.3
Domergue, F.4
Egberts, T.C.5
Leufkens, H.G.6
-
31
-
-
84939897101
-
-
Directive 2010/84/EU of the European Parliament and of the Council of 15 amending, as regards pharmacovigilance, Directive 2001/83/EC on the community code relating to medicinal products for human use
-
Directive 2010/84/EU of the European Parliament and of the Council of 15 amending, as regards pharmacovigilance, Directive 2001/83/EC on the community code relating to medicinal products for human use. Off J Eur Union. 2010;2010(348):74-99.
-
(2010)
Off J Eur Union.
, vol.2010
, Issue.348
, pp. 74-99
-
-
-
34
-
-
30744472175
-
Medication errors in a pharmacy-based bar-code-repackaging center
-
16390931
-
Cina J, Fanikos J, Mitton P, McCrea M, Churchill W. Medication errors in a pharmacy-based bar-code-repackaging center. Am J Health Syst Pharm. 2006;63(2):165-8.
-
(2006)
Am J Health Syst Pharm.
, vol.63
, Issue.2
, pp. 165-168
-
-
Cina, J.1
Fanikos, J.2
Mitton, P.3
McCrea, M.4
Churchill, W.5
-
37
-
-
84939898543
-
-
US Food and Drug Administration Rockville: Center for Drug Evaluation and Research; 2012 (contract no. 3169145)
-
US Food and Drug Administration. Proprietary name review(s): BLA 125294 - [xxx]-filgrastim. Rockville: Center for Drug Evaluation and Research; 2012 (contract no. 3169145).
-
Proprietary Name Review(s): BLA 125294 - [Xxx]-filgrastim
-
-
-
38
-
-
84939886355
-
-
US Food and Drug Administration Accessed 18 February 2014.
-
US Food and Drug Administration. Ziv-aflibercept. 2012. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm3144htm. Accessed 18 February 2014.
-
(2012)
Ziv-aflibercept
-
-
|