Biosimilars Sponsors Seek Changes In US FDA Guidance On Comparative Analytical Assessments
Companies generally support decision not to require statistical equivalence testing but challenge agency’s skepticism about combining data from US and foreign reference products to set analytical similarity acceptance criteria.
You may also be interested in...
New draft guidance on statistical approaches eliminates previous recommendations on tiered ranking and statistical equivalence testing of product quality attributes, giving biosimilar sponsors more flexibility.
Ability to design a statistical analysis plan is hampered by lack of control over, and even knowledge of, changes in the reference product's quality attributes over time, biosimilar industry says in comments on US FDA's draft guidance on statistical approaches to analytical similarity; companies seek more flexibility on statistical testing methods and on source and number of products lots for analytical comparisons.
Clinical Trial Diversity Planning Requires Prevalence-Based Enrollment Goals, Metrics For Gauging Success
Academic and industry experts caution against relying on historical enrollment numbers when setting new targets for under-represented populations and tout real-time monitoring dashboards, as well as a role for data monitoring committees, in assessing whether targets are being met in ongoing studies.