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...
Biosimilars: US FDA Favors Quality Range Testing For Comparative Analytical Assessments
New draft guidance on statistical approaches eliminates previous recommendations on tiered ranking and statistical equivalence testing of product quality attributes, giving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.
Biosimilar Sponsors Seek Statistical Flexibility When Reference Products Change
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of, changes in the reference product's quality attributes over time, biosimilar industry says in comments on US FDA's draft guidance on statistical approaches to analytical similarity; companies seek more flexibility on statistical testing methods and on source and number of products lots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.
Big Drug, Small Panel: US FDA Adcomm For Eisai/Biogen’s Leqembi Includes Only Six Voting Members
Six is the fewest number of voting experts for a drug or biologic advisory committee dating back to at least 2015, according to the Pink Sheet Performance Tracker. Agency issued two conflict-of-interest waivers for the meeting, one of which was to a site principal investigator on lecanemab and aducanumab studies but who is no longer participating in the Leqembi review.