Regulatory strategy for the development of analytical methods for the routine determination of aggregate profiles for a biosimilar product

The presence of aggregates in biopharmaceutical products has long been considered a concern to product safety and product quality. Specifications for acceptable levels of aggregates for a novel therapeutic protein are typically set based on manufacturing capability and clinical qualification. While these parameters are still relevant for biosimilars, additional strategy must also be applied to ensure that the aggregate profile is acceptable in comparison to the originator product, both in terms of number and types of aggregates present. This article discusses regulatory strategy that may be employed in the development of analytical methods and specifications for a biosimilar product.