Biosimilars for the treatment of patients with psoriasis : A consensus statement from the Biosimilar Working Group of the International Psoriasis Council
Cohen, Arnon (Clalit Health Services (Tel Aviv, Israel))
Vender, Ronald (Dermatrials Research, Hamilton, Ontario, Canada)
Naldi, Luigi (Ospedale san Bortolo (Vicenza, Itàlia))
Kalb, Robert E. (SUNY at Buffalo School of Medicine and Biomedical Sciences)
Torres, Tiago (Centro Hospitalar Universitário do Porto)
Rajagopalan, Murlidhar (Apollo Hospitals (Chennai, Índia))
van der Walt, Joelle (PRI Healthcare Solutions, Paramus, New Jersey)
Puig Sanz, Lluís (Institut d'Investigació Biomèdica Sant Pau)
Young, Helen S.. (Department of Dermatology, Manchester Academic Health Science Center, Salford Royal Hospital (Hope), The University of Manchester)
Universitat Autònoma de Barcelona

Data:	2020
Resum:	As biosimilars have become available in various parts of the world, the International Psoriasis Council has reviewed aspects of their use. To provide consensus statements from the Biosimilar Working Group about the use of biosimilars in patients with psoriasis. 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. 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. " 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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Biosimilars ; Interchangeability ; International Psoriasis Council ; Psoriasis ; Switching ; Tumor necrosis factor inhibitors ; BSWG, Biosimilar Working Group ; IPC, International Psoriasis Council ; NGT, nominal group technique
Publicat a:	JAAD International, Vol. 1 (november 2020) , p. 224-230, ISSN 2666-3287

DOI: 10.1016/j.jdin.2020.09.006
PMID: 34409344

7 p, 228.0 KB

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