Biosimilar Development

Description: The extent of clinical therapeutic equivalence data required to support marketing approval of biosimilars is currently an area of intense debate. The UK MHRA advocate in many cases, a comparative efficacy trial (CET) is not needed. EMA has recently (1st April) released a draft Reflection Paper on a tailored clinical approach in Biosimilar development for public consultation. FDA are working on revised guideline and are currently advising that waiver of CETs could be justified for more complex proteins.

This session will introduce the key elements of biosimilarity and how advancements in analytical methods allows for high-resolution comparisons between biosimilars and reference products. An approach to a more integrated assessments of the total data package to facilitate tailoring biosimilar clinical development, will be discussed. The session will emphasise the need for a science-based approach to biosimilar development that leverages advanced analytical techniques and accumulated knowledge to limit the need for complex and expensive clinical trials while still maintaining high standards for safety and efficacy.