Comparing Biosimilars To Drifting Reference Product Data

First-time biosimilar developers might be surprised to find significant lot-to-lot quality attribute shifts in their reference product.  

During Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval, Cecilia Michel a managing director at Alvotech, said, by default, none of these attributes should be critical quality attributes, but they still matter. To make a defensible biosimilarity assessment, it's important to understand the reference product over a sufficient period of time, which is challenging to do when speed to market is one of the biggest incentives for biosimilars in the first place.