Tutorials are not included in the meeting registration and require a separate registration fee

The first step in achieving biosimilarity is to ensure that the critical quality attributes (CQAs) of the biosimilar closely align to those of the reference product. To address this, there is a need to understand the importance of different attributes in terms of achieving biosimilarity. FDA has introduced a system for ranking of CQAs and the setting of equivalence criteria. But this approach raises many questions such as what factors need to be considered in such ranking of CQAs? How many batches should be compared? Is it reasonable to establish equivalence margins? And if so how tight should these margins be? These questions are of profound importance as setting criteria unnecessarily tight would limit the potential for development of approvable biosimilars and thereby limit the availability of affordable biological medicines. On the other hand, allowing too much latitude could introduce uncertainty with potential impact on safety and potency of biosimilar medicines. This tutorial will debate these issues considering the importance of CQAs based on their impact on structure, function and therapeutic relevance, and how close a match ought to be achieved to the reference product.