Hospital Pharmacy - September 2017 - 545
545
Gabay
In summary, as the FDA evaluates and approves more
biosimilars, state legislatures have become increasingly concerned regarding the appropriate method for substituting a
biologic reference product with a biosimilar. Over the past
few years, many state legislatures have enacted laws calling
for a variety of requirements necessary for a legal biosimilar
substitution. Currently, none of the approved biosimilars in
the United States are designated as interchangeable by the
FDA; however, once this occurs, these laws will begin to
take effect across the nation and pharmacists should be aware
of how these will impact their pharmacy practice.
References
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2.
3.
4.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect
to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
5.
Information on biosimilars. https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/
approvalapplications/therapeuticbiologicapplications/biosimilars/. Updated May 10, 2016. Accessed July 26, 2017.
Olech E. Biosimilars: rationale and current regulatory landscape. Semin Arthritis Rheum. 2016;45(5)(suppl):S1-S10.
From our perspective: interchangeable biological products.
https://www.fda.gov/Drugs/NewsEvents/ucm536528.htm.
Updated July 18, 2017. Accessed July 26, 2017.
Purple book: lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability
evaluations. https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm411418.
htm. Updated July 21, 2017. Accessed July 26, 2017.
State laws and legislation related to biologic medications
and substitution of biosimilars. http://www.ncsl.org/research/
health/state-laws-and-legislation-related-to-biologic-medications-and-substitution-of-biosimilars.aspx. Updated July 1,
2017. Accessed July 26, 2017.
https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/
https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/
https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/
https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/
https://www.fda.gov/Drugs/NewsEvents/ucm536528.htm
https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm411418.htm
https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm411418.htm
https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm411418.htm
https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm411418.htm
http://www.ncsl.org/research/health/state-laws-and-legislation-related-to-biologic-medications-and-substitution-of-biosimilars.aspx
http://www.ncsl.org/research/health/state-laws-and-legislation-related-to-biologic-medications-and-substitution-of-biosimilars.aspx
http://www.ncsl.org/research/health/state-laws-and-legislation-related-to-biologic-medications-and-substitution-of-biosimilars.aspx
Table of Contents for the Digital Edition of Hospital Pharmacy - September 2017
Pharmacy Transitions of Care and Culture
Bivalirudin Medication Use Evaluation and Cost Savings Initiative
Navigating the New Antimicrobial Stewardship Regulations
Safinamide
Biosimilar Substitution Laws
Evaluation of Corticosteroid Dose in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Hazardous Drug Contamination of Drug Preparation Devices and Staff: A Contamination Study Simulating the Use of Chemotherapy Drugs in a Clinical Setting
A Case of Metronidazole Injection Infiltration Without Sequelae
Doubling Pharmacist Coverage in the Intensive Care Unit: Impact on the Pharmacists’ Clinical Activities and Team Members’ Satisfaction
Extended Stability of Epinephrine Hydrochloride Injection in Polyvinyl Chloride Bags Stored in Amber Ultraviolet Light–Blocking Bags
Formation of a Citywide Pharmacy Residents’ Collaborative Committee
Hospital Pharmacy - September 2017 - 513
Hospital Pharmacy - September 2017 - 514
Hospital Pharmacy - September 2017 - 515
Hospital Pharmacy - September 2017 - 516
Hospital Pharmacy - September 2017 - 517
Hospital Pharmacy - September 2017 - 518
Hospital Pharmacy - September 2017 - 519
Hospital Pharmacy - September 2017 - Pharmacy Transitions of Care and Culture
Hospital Pharmacy - September 2017 - 521
Hospital Pharmacy - September 2017 - Bivalirudin Medication Use Evaluation and Cost Savings Initiative
Hospital Pharmacy - September 2017 - 523
Hospital Pharmacy - September 2017 - 524
Hospital Pharmacy - September 2017 - 525
Hospital Pharmacy - September 2017 - 526
Hospital Pharmacy - September 2017 - Navigating the New Antimicrobial Stewardship Regulations
Hospital Pharmacy - September 2017 - 528
Hospital Pharmacy - September 2017 - 529
Hospital Pharmacy - September 2017 - 530
Hospital Pharmacy - September 2017 - 531
Hospital Pharmacy - September 2017 - Safinamide
Hospital Pharmacy - September 2017 - 533
Hospital Pharmacy - September 2017 - 534
Hospital Pharmacy - September 2017 - 535
Hospital Pharmacy - September 2017 - 536
Hospital Pharmacy - September 2017 - 537
Hospital Pharmacy - September 2017 - 538
Hospital Pharmacy - September 2017 - 539
Hospital Pharmacy - September 2017 - 540
Hospital Pharmacy - September 2017 - 541
Hospital Pharmacy - September 2017 - 542
Hospital Pharmacy - September 2017 - 543
Hospital Pharmacy - September 2017 - Biosimilar Substitution Laws
Hospital Pharmacy - September 2017 - 545
Hospital Pharmacy - September 2017 - Evaluation of Corticosteroid Dose in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Hospital Pharmacy - September 2017 - 547
Hospital Pharmacy - September 2017 - 548
Hospital Pharmacy - September 2017 - 549
Hospital Pharmacy - September 2017 - 550
Hospital Pharmacy - September 2017 - Hazardous Drug Contamination of Drug Preparation Devices and Staff: A Contamination Study Simulating the Use of Chemotherapy Drugs in a Clinical Setting
Hospital Pharmacy - September 2017 - 552
Hospital Pharmacy - September 2017 - 553
Hospital Pharmacy - September 2017 - 554
Hospital Pharmacy - September 2017 - 555
Hospital Pharmacy - September 2017 - 556
Hospital Pharmacy - September 2017 - 557
Hospital Pharmacy - September 2017 - 558
Hospital Pharmacy - September 2017 - A Case of Metronidazole Injection Infiltration Without Sequelae
Hospital Pharmacy - September 2017 - 560
Hospital Pharmacy - September 2017 - 561
Hospital Pharmacy - September 2017 - 562
Hospital Pharmacy - September 2017 - 563
Hospital Pharmacy - September 2017 - Doubling Pharmacist Coverage in the Intensive Care Unit: Impact on the Pharmacists’ Clinical Activities and Team Members’ Satisfaction
Hospital Pharmacy - September 2017 - 565
Hospital Pharmacy - September 2017 - 566
Hospital Pharmacy - September 2017 - 567
Hospital Pharmacy - September 2017 - 568
Hospital Pharmacy - September 2017 - 569
Hospital Pharmacy - September 2017 - Extended Stability of Epinephrine Hydrochloride Injection in Polyvinyl Chloride Bags Stored in Amber Ultraviolet Light–Blocking Bags
Hospital Pharmacy - September 2017 - 571
Hospital Pharmacy - September 2017 - 572
Hospital Pharmacy - September 2017 - 573
Hospital Pharmacy - September 2017 - Formation of a Citywide Pharmacy Residents’ Collaborative Committee
Hospital Pharmacy - September 2017 - 575
Hospital Pharmacy - September 2017 - 576
Hospital Pharmacy - September 2017 - 577
Hospital Pharmacy - September 2017 - 578
Hospital Pharmacy - September 2017 - 579
Hospital Pharmacy - September 2017 - 580
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