Biosimilars for the treatment of patients with psoriasis: A consensus statement from the Biosimilar Working Group of the International Psoriasis CouncilCapsule Summary
Background: As biosimilars have become available in various parts of the world, the International Psoriasis Council has reviewed aspects of their use. Objective: To provide consensus statements from the Biosimilar Working Group about the use of biosimilars in patients with psoriasis. Methods: A semi...
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doaj-0b6f4a54dbc947d2a36e56b94f2b29b12021-03-22T08:44:20ZengElsevierJAAD International2666-32872020-12-0112224230Biosimilars for the treatment of patients with psoriasis: A consensus statement from the Biosimilar Working Group of the International Psoriasis CouncilCapsule SummaryArnon D. Cohen, MD, MPH, PhD0Ronald Vender, MD, FRCPC1Luigi Naldi, MD2Robert E. Kalb, MD3Tiago Torres, MD, PhD4Murlidhar Rajagopalan, MD5Joelle van der Walt, PhD6Lluís Puig, MD (Hon), PhD7Helen S. Young, MB ChB, PhD, FRCP8Siaal Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Quality Measurements and Research, Clalit Health Services, Tel Aviv, Israel; Correspondence to: Arnon D. Cohen, MD, MPH, PhD, Siaal Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.Dermatrials Research, Hamilton, Ontario, CanadaDepartment of Dermatology, Ospedale san Bortolo, Vicenza, ItalyDepartment of Dermatology, SUNY at Buffalo School of Medicine and Biomedical Sciences, Buffalo, New YorkDepartment of Dermatology, Centro Hospitalar Universitário do Porto, Porto, PortugalDepartment of Dermatology, Apollo Hospitals, Chennai, IndiaPRI Healthcare Solutions, Paramus, New JerseyDepartment of Dermatology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona Medical School, Barcelona, SpainDepartment of Dermatology, Manchester Academic Health Science Center, Salford Royal Hospital (Hope), The University of Manchester, Salford, United KingdomBackground: As biosimilars have become available in various parts of the world, the International Psoriasis Council has reviewed aspects of their use. Objective: To provide consensus statements from the Biosimilar Working Group about the use of biosimilars in patients with psoriasis. Methods: A semiqualitative structured process was employed to approve the consensus statements on biosimilars using the nominal group technique. The final statements were validated by a survey of the paricipants. The approval of the consensus statements was predefined as >80% positive opinions. Results: A consensus was reached in 36/38 statements regarding regulatory considerations, extrapolation of indication, interchangeability, substitution at the pharmacy level, pharmacovigilance, traceability, naming, biosimilar policy, education, and cost of biosimilars. Example statements include “Switching a stable patient from a reference product to a biosimilar product is appropriate if the patient and physician agree to do so” and “Patients and patients' organisations should be involved in all decision making and policy development about the use of biosimilars.” Conclusion: The International Psoriasis Council Biosimilar Working Group provides consensus statements for the use of biosimilars in the treatment of patients with psoriasis. We suggest that these statements provide global guidance to clinicians, healthcare organizations, pharmaceutical companies, regulators, and patients regarding the development and use of biosimilars in patients with psoriasis.http://www.sciencedirect.com/science/article/pii/S2666328720300523biosimilarsinterchangeabilityInternational Psoriasis Councilpsoriasisswitchingtumor necrosis factor inhibitors |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Arnon D. Cohen, MD, MPH, PhD Ronald Vender, MD, FRCPC Luigi Naldi, MD Robert E. Kalb, MD Tiago Torres, MD, PhD Murlidhar Rajagopalan, MD Joelle van der Walt, PhD Lluís Puig, MD (Hon), PhD Helen S. Young, MB ChB, PhD, FRCP |
spellingShingle |
Arnon D. Cohen, MD, MPH, PhD Ronald Vender, MD, FRCPC Luigi Naldi, MD Robert E. Kalb, MD Tiago Torres, MD, PhD Murlidhar Rajagopalan, MD Joelle van der Walt, PhD Lluís Puig, MD (Hon), PhD Helen S. Young, MB ChB, PhD, FRCP Biosimilars for the treatment of patients with psoriasis: A consensus statement from the Biosimilar Working Group of the International Psoriasis CouncilCapsule Summary JAAD International biosimilars interchangeability International Psoriasis Council psoriasis switching tumor necrosis factor inhibitors |
author_facet |
Arnon D. Cohen, MD, MPH, PhD Ronald Vender, MD, FRCPC Luigi Naldi, MD Robert E. Kalb, MD Tiago Torres, MD, PhD Murlidhar Rajagopalan, MD Joelle van der Walt, PhD Lluís Puig, MD (Hon), PhD Helen S. Young, MB ChB, PhD, FRCP |
author_sort |
Arnon D. Cohen, MD, MPH, PhD |
title |
Biosimilars for the treatment of patients with psoriasis: A consensus statement from the Biosimilar Working Group of the International Psoriasis CouncilCapsule Summary |
title_short |
Biosimilars for the treatment of patients with psoriasis: A consensus statement from the Biosimilar Working Group of the International Psoriasis CouncilCapsule Summary |
title_full |
Biosimilars for the treatment of patients with psoriasis: A consensus statement from the Biosimilar Working Group of the International Psoriasis CouncilCapsule Summary |
title_fullStr |
Biosimilars for the treatment of patients with psoriasis: A consensus statement from the Biosimilar Working Group of the International Psoriasis CouncilCapsule Summary |
title_full_unstemmed |
Biosimilars for the treatment of patients with psoriasis: A consensus statement from the Biosimilar Working Group of the International Psoriasis CouncilCapsule Summary |
title_sort |
biosimilars for the treatment of patients with psoriasis: a consensus statement from the biosimilar working group of the international psoriasis councilcapsule summary |
publisher |
Elsevier |
series |
JAAD International |
issn |
2666-3287 |
publishDate |
2020-12-01 |
description |
Background: As biosimilars have become available in various parts of the world, the International Psoriasis Council has reviewed aspects of their use. Objective: To provide consensus statements from the Biosimilar Working Group about the use of biosimilars in patients with psoriasis. Methods: A semiqualitative structured process was employed to approve the consensus statements on biosimilars using the nominal group technique. The final statements were validated by a survey of the paricipants. The approval of the consensus statements was predefined as >80% positive opinions. Results: A consensus was reached in 36/38 statements regarding regulatory considerations, extrapolation of indication, interchangeability, substitution at the pharmacy level, pharmacovigilance, traceability, naming, biosimilar policy, education, and cost of biosimilars. Example statements include “Switching a stable patient from a reference product to a biosimilar product is appropriate if the patient and physician agree to do so” and “Patients and patients' organisations should be involved in all decision making and policy development about the use of biosimilars.” Conclusion: The International Psoriasis Council Biosimilar Working Group provides consensus statements for the use of biosimilars in the treatment of patients with psoriasis. We suggest that these statements provide global guidance to clinicians, healthcare organizations, pharmaceutical companies, regulators, and patients regarding the development and use of biosimilars in patients with psoriasis. |
topic |
biosimilars interchangeability International Psoriasis Council psoriasis switching tumor necrosis factor inhibitors |
url |
http://www.sciencedirect.com/science/article/pii/S2666328720300523 |
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