Putting the value into biosimilar decision making: the judgment value criteria.
Uncertainties remain the key issue surrounding biosimilars, although decisions regarding their use must be made. The challenges for policymakers, doctors, patients and others seeking to navigate in the uncharted waters of biosimilars must be clarified. At the most basic level, scientific understanding of the issue remains limited and when making decisions, policymakers must consider all those affected by health policy decisions, particularly the ultimate recipients of these medicines: the patients. The biosimilar-value chain relies on measurement of comparabilities. The goal is to demonstrate how, from a molecular perspective, closely similar they are or are not and how potential small differences may be relevant to clinical outcomes. To critically understand these points, this conceptual paper will present a knowledge-value chain and discuss each dimension assigning value in the decision making process re-utilization of biosimilars.
Department of Medicine, Universidade Federal de São Carlos. Electronic address: mirhelen@terra.com.br.
Mirhelen
M
Mendes de Abreu
Adjunct Division of Immunology/Rheumatology, Stanford University School of Medicine. Electronic address: vstrand@aol.com.
Vibeke
V
Strand
Department of Medicine, Universidade do Estado do Rio de Janeiro. Electronic address: roger.a.levy@gmail.com.
Roger Abramino
RA
Levy
Department of Medicine, Universidade do Estado do Rio de Janeiro. Electronic address: denizarvianna@gmail.com.
Denizar Vianna
DV
Araujo
D059451:Biosimilar Pharmaceuticals / Q000494:pharmacology*; D003657:Decision Making; D006801:Humans; D007600:Judgment; D024382:Professional Role
D059451:Biosimilar Pharmaceuticals
Biosimilars; Decision process; Immunogenicity; Value chain; Value in health