The Comparability & Biosimilarity (Part of Biotherapeutics Analytical Summit 2018) covers topics such as:
- Analytical strategies and techniques to evaluate batch-to-batch comparability during process, site or manufacturing changes
- Regulatory requirements and guidelines on comparability and biosimilarity assessments
- Strategies toward ICH harmonization in comparability and biosimilarity
- Equivalence testing of biosimilars with innovator products plus the use of mathematical modeling and statistical data to establish analytical biosimilarity
The Comparability & Biosimilarity (Part of Biotherapeutics Analytical Summit 2018) brings together scientists with responsibilities in analytical development in comparability or biosimilarity assessment.