Webinar | January 30, 2017

Biosimilars: Regulatory Trends and Quality Control Testing Requirements

Source: MilliporeSigma
MilliporeSigma

Biopharmaceuticals are manufactured through complex biochemical process utilizing living systems, and require multiple steps to purify, increasing the risk of extensive batch-to-batch variability.

The more complex process of creating a generic version of a biologic has resulted in regulators defining the replicate drug as similar, but not identical, resulting in the globally accepted term biosimilar .

This webinar will review regulatory expectations in assessing the comparability of biosimilars through protein chemistry techniques and cell based bioassays. Key considerations for developing robust bioassays for biosimilar comparison will be presented.