-
1
-
-
84934780445
-
-
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. April, Available at, Accessed June 1, 2015
-
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. April 2015. Available at: http://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/UCM291128.pdf. Accessed June 1, 2015.
-
(2015)
-
-
-
2
-
-
84934758414
-
Omnitrope (somatropin)
-
Authorisation details. Available at, Accessed June 1, 2015
-
European Medicines Agency. Omnitrope (somatropin). Authorisation details. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/ medicines/human/medicines/000607/human_med_000946.jsp&mid= WC0b01ac058001d124. Accessed June 1, 2015..
-
-
-
-
3
-
-
36348937220
-
Biosimilar drugs: concerns and opportunities
-
Genazzani AA, Biggio G, Caputi AP, et al. Biosimilar drugs: concerns and opportunities. BioDrugs. 2007;21(6):351-56.
-
(2007)
BioDrugs
, vol.21
, Issue.6
, pp. 351-356
-
-
Genazzani, A.A.1
Biggio, G.2
Caputi, A.P.3
-
4
-
-
40549112722
-
Similarity of biotechnology-derived medicinal products:specific problems and new regulatory framework
-
Available at, Accessed June 1, 2015
-
Prugnaud JL. Similarity of biotechnology-derived medicinal products:specific problems and new regulatory framework. Br J Clin Pharmacol.2008;65(4):619-20. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/ PMC2291378/. Accessed June 1, 2015.
-
(2008)
Br J Clin Pharmacol.
, vol.65
, Issue.4
, pp. 619-620
-
-
Prugnaud, J.L.1
-
5
-
-
0141922918
-
Shifting paradigms: biopharmaceuticals versus low molecular weight drugs
-
Crommelin DJ, Storm G, Verrijk R, de Leede L, Jiskoot W, Hennink WE. Shifting paradigms: biopharmaceuticals versus low molecular weight drugs.Int J Pharm.2003;266(1-2):3-16.
-
(2003)
Int J Pharm.
, vol.266
, Issue.1-2
, pp. 3-16
-
-
Crommelin, D.J.1
Storm, G.2
Verrijk, R.3
de Leede, L.4
Jiskoot, W.5
Hennink, W.E.6
-
6
-
-
47349126691
-
Biosimilars: policy, clinical, and regulatory considerations
-
Gottlieb S. Biosimilars: policy, clinical, and regulatory considerations.Am J Health Syst Pharm.2008;65(14 Suppl 6):S2-S8
-
(2008)
Am J Health Syst Pharm.
, vol.65
, pp. S2-S8
-
-
Gottlieb, S.1
-
7
-
-
33746169811
-
Biosimilars: How similar or dissimilar are they?
-
Roger SD. Biosimilars: How similar or dissimilar are they? Nephrology (Carlton).2006;11(4):341-46.
-
(2006)
Nephrology (Carlton).
, vol.11
, Issue.4
, pp. 341-346
-
-
Roger, S.D.1
-
8
-
-
84934780446
-
-
Federal Food, Drug, and Cosmetic Act. 21 U.S.C., chapter 9. Available at, Accessed June 1, 2015
-
Federal Food, Drug, and Cosmetic Act. 21 U.S.C., chapter 9. Available at:http://www.fda.gov/RegulatoryInformation/Legislation/Federal FoodDrugandCosmeticActFDCAct/default.htm. Accessed June 1, 2015.
-
-
-
-
9
-
-
84934780447
-
-
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products-general considerations. Revision March 1, Available at, Accessed June 1, 2015
-
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products-general considerations. Revision March 1, 2003. Available at: http://www.fda.gov/ohrms/dockets/ac/03/briefing/3995B1_07_GFIBioAvail-BioEquiv.pdf. Accessed June 1, 2015.
-
(2003)
-
-
-
10
-
-
84934780448
-
-
Public Health Service Act. 42 U.S.C., chapter 6A. Available at, Accessed June 1, 2015
-
Public Health Service Act. 42 U.S.C., chapter 6A. Available at: http:// www.fda.gov/RegulatoryInformation/Legislation/ucm148717.htm. Accessed June 1, 2015.
-
-
-
-
11
-
-
84934780449
-
-
Biologics Price Competition and Innovation Act. Public Law 111-148, section 7001-7003. Available at, Accessed June 1, 2015
-
Biologics Price Competition and Innovation Act. Public Law 111-148, section 7001-7003. Available at: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/UCM216146.pdf. Accessed June 1, 2015.
-
-
-
-
12
-
-
84934780450
-
-
Patient Protection and Affordable Care Act. Public Law 111-148. Available at, Accessed June 1, 2015
-
Patient Protection and Affordable Care Act. Public Law 111-148. Available at: http://www.gpo.gov/fdsys/pkg/BILLS-111hr3590enr/pdf/BILLS-111hr3590enr.pdf. Accessed June 1, 2015.
-
-
-
-
14
-
-
46049102220
-
ASHP guidelines on the pharmacy and therapeutics committee and the formulary system
-
Tyler LS, Cole SW, May JR, et al. ASHP guidelines on the pharmacy and therapeutics committee and the formulary system. Am J Health Syst Pharm.2008;65(13):1272-83.
-
(2008)
Am J Health Syst Pharm.
, vol.65
, Issue.13
, pp. 1272-1283
-
-
Tyler, L.S.1
Cole, S.W.2
May, J.R.3
-
15
-
-
35348956856
-
-
6th ed. Sudbury, MA: Jones & Bartlett Publishers
-
Abood, RR. Pharmacy Practice and the Law. 6th ed. Sudbury, MA: Jones & Bartlett Publishers; 2010.
-
(2010)
Pharmacy Practice and the Law
-
-
Abood, R.R.1
-
16
-
-
84934780451
-
-
U.S. Food and Drug Administration. Orange Book preface. Available at, Accessed June 1, 2015
-
U.S. Food and Drug Administration. Orange Book preface. Available at:http://www.fda.gov/drugs/developmentapprovalprocess/ucm079068.htm. Accessed June 1, 2015.
-
-
-
-
17
-
-
84861117148
-
-
Available at, Accessed June 1, 2015
-
State regulations on generic substitution. Pharmacist's Letter/Prescriber's Letter. 2006;22(9):220901. Available at: http://pharmacistsletter.therapeuticresearch. com/pl/ArticlePDF.aspx?dd=220901&segment=1186. Accessed June 1, 2015.
-
(2006)
Pharmacist's Letter/Prescriber's Letter
, vol.22
, Issue.9
, pp. 220901
-
-
-
18
-
-
48649105309
-
Generic-substitution laws
-
Vivian JC. Generic-substitution laws. US Pharm. 2008;33(6):30-34.
-
(2008)
US Pharm
, vol.33
, Issue.6
, pp. 30-34
-
-
Vivian, J.C.1
-
19
-
-
84906675701
-
Generic drug substitution requires pharmacist attention to ensure compliance with state laws and regulations
-
Available at, Accessed June 15, 2015
-
National Association of Boards of Pharmacy. Generic drug substitution requires pharmacist attention to ensure compliance with state laws and regulations. National Association of Boards of Pharmacy Newsletter.2013;42(6):135-36,140. Available at: http://www.nabp.net/system/redactor_ assets/documents/618/Final_June-July_2013_Newsletter.pdf. Accessed June 15, 2015.
-
(2013)
National Association of Boards of Pharmacy Newsletter.
, vol.42
, Issue.6
, pp. 135-136+140
-
-
-
20
-
-
84934780452
-
-
U.S. Food and Drug Administration. Code of Federal Regulations, Title 21 Section 320.33(c). Available at, Accessed June 1, 2015
-
U.S. Food and Drug Administration. Code of Federal Regulations, Title 21 Section 320.33(c). Available at: http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=320.33. Accessed June 1, 2015.
-
-
-
-
22
-
-
79961116944
-
Developing the nation's biosimilars program
-
Available at, Accessed June 1, 2015
-
Kozlowski S, Woodcock J, Midthun K, Behrman Sherman RB. Developing the nation's biosimilars program. N Engl J Med.2011;365(5):385-88. Available at: http://www.nejm.org/doi/full/10.1056/NEJMp1107285. Accessed June 1, 2015.
-
(2011)
N Engl J Med.
, vol.365
, Issue.5
, pp. 385-388
-
-
Kozlowski, S.1
Woodcock, J.2
Midthun, K.3
Behrman Sherman, R.B.4
-
23
-
-
84934780453
-
List of licensed biological products with (1) reference product exclusivity and (2) biosimilarity or interchangeability evaluations to date
-
Available at: , Accessed June 1, 2015
-
U.S. Food and Drug Administration, Center for Drug Evauation Research. List of licensed biological products with (1) reference product exclusivity and (2) biosimilarity or interchangeability evaluations to date. Available at: http://www.fda.gov/downloads/Drugs/ DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ UCM411909.pdf. Accessed June 1, 2015.
-
-
-
-
24
-
-
84934780454
-
-
Biotechnology Industry Organization. BIO principles on patient safety in the substitution of biologic products. January 24, 2013. Available at, Accessed June 1, 2015
-
Biotechnology Industry Organization. BIO principles on patient safety in the substitution of biologic products. January 24, 2013. Available at: http:// www.bio.org/advocacy/letters/bio-principles-patient-safety-substitutionbiologic- products. Accessed June 1, 2015.
-
-
-
-
25
-
-
84934780455
-
-
Academy of Managed Care Pharmacy. Where we stand: biosimilar drug therapies. April 2012. Available at, Accessed June 15, 2015
-
Academy of Managed Care Pharmacy. Where we stand: biosimilar drug therapies. April 2012. Available at: http://www.amcp.org/WorkArea/ DownloadAsset.aspx?id=18693. Accessed June 15, 2015.
-
-
-
-
26
-
-
84934780456
-
-
American Pharmacists Association, National Association of Chain Drug Stores, National Community Pharmacists Association. Letter to U.S. Food and Drug Administration, Division of Dockets Management (HFA-305). May 25, 2012. Available at, Accessed June 1, 2015
-
American Pharmacists Association, National Association of Chain Drug Stores, National Community Pharmacists Association. Letter to U.S. Food and Drug Administration, Division of Dockets Management (HFA-305). May 25, 2012. Available at: http://www.ncpanet.org/pdf/leg/may12/joint_biosimilar_ letter.pdf. Accessed June 1, 2015.
-
-
-
-
27
-
-
84934780457
-
-
European Commission. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, directive 2001/83/EC on the Community code relating to medicinal products for human use. 2010 OJ L348/74. Available at, Accessed June 1, 2015
-
European Commission. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, directive 2001/83/EC on the Community code relating to medicinal products for human use. 2010 OJ L348/74. Available at: http:// ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_en.pdf. Accessed June 1, 2015.
-
-
-
-
28
-
-
0027394923
-
A sudden increase in factor VIII inhibitor development in multitransfused hemophilia A patients in The Netherlands. Dutch Hemophilia Study Group
-
Available at, Accessed June 1, 2015
-
Rosendaal FR, Nieuwenhuis HK, van den Berg HM et al. A sudden increase in factor VIII inhibitor development in multitransfused hemophilia A patients in The Netherlands. Dutch Hemophilia Study Group.Blood. 1993;81(8):2180-86. Available at: http://www.bloodjournal.org/content/81/8/2180.long. Accessed June 1, 2015.
-
(1993)
Blood
, vol.81
, Issue.8
, pp. 2180-2186
-
-
Rosendaal, F.R.1
Nieuwenhuis, H.K.2
van den Berg, H.M.3
-
29
-
-
79958824101
-
Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies
-
Praditpornsilpa K, Tiranathanagul K, Kupatawintu P, et al. Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies. Kidney Int. 2011;80(1):88-92.
-
(2011)
Kidney Int
, vol.80
, Issue.1
, pp. 88-92
-
-
Praditpornsilpa, K.1
Tiranathanagul, K.2
Kupatawintu, P.3
-
30
-
-
84885044293
-
Pure red cell aplasia after treatment of renal anaemia with epoetin theta
-
Wieser C, Rosenkranz AR. Pure red cell aplasia after treatment of renal anaemia with epoetin theta. Clin Kidney J.2013;6(5):539-42.
-
(2013)
Clin Kidney J.
, vol.6
, Issue.5
, pp. 539-542
-
-
Wieser, C.1
Rosenkranz, A.R.2
|