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.