Oxana Iliach
Sr. Director Quintiles IMS, Canada
Title: Strategy for the global development of biosimilars: Putting it’s all together
Biography
Biography: Oxana Iliach
Abstract
Growing numbers of companies are pursuing a global development of biosimilars for multiple markets. This global approach presents multiple challenges from selecting a reference product for biosimilar development to designing and conducting a clinical trials including a marketing strategy development and pharmacovigilance program. How to ensure that the global development results in successful marketing authorization in each jurisdiction? How to incorporate specific country requirements for biosimilar development at the early stages of biosimilar program? The strategic approach to the alignment of product development, regulatory activities and clinical program provides an answer to these questions. This presentation will discuss strategy of the biosimilar product development through earlier development to regulatory approval and provide some practical examples.