Biosimilar Formulation Strategy

Key to ensuring a sustainable formulation strategy for your biosimilar drug product is to have a proper understanding of the limitations dictated by the Originator formulation. Fortunately, when working with biosimilar development we already get a head start by searching information about the reference medicinal product. Therefore, the starting point before biosimilar formulation screening should always be a thorough scrutiny of the publicly available information such as the patent literature, authority data bases (EMA & FDA) and scientific publications. The collected information will hint you towards what type of functional excipients are used and their concentrations , product pH and primary packaging materials. If you are looking for inspiration on excipients used in other commercial products in the same product category then the FDA Purple Book offers inspiration on all FDA-licensed (approved) biological products

In below illustration a decision tree is presented to facilitate strategic decision-making on biosimilar formulation strategy for lead selection.