Developing a Comprehensive Analytical Similarity Program for Establishing Biosimilarity

After the approval of the Affordable Care Act, the US FDA issued several guidance documents, providing a regulatory pathway for development and approval of biosimilars. One very critical step in developing a biosimilar is the creation of a solid analytical strategy that will provide the needed physical, chemical, and biological properties of both originator and biosimilar products such that similarity can be established.

In this presentation, an approach for identifying QTPP attributes and CQA’s along with other comparability and the appropriate stress studies/accelerated stability conditions to demonstrate similarity will be discussed.

Presenter

  • Mario DiPaola, PhD, Senior Scientific Director, Protein Characterization, Charles River