Date: July 20, 2017
Time: 10:00-11:00 AM Eastern
Registration: Sign up at below and Adobe Connect link will be provided
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created an abbreviated pathway for licensing of biological drug products that are shown to be ‘biosimilar’ to reference drug products already licensed by the FDA. A biosimilar product is one that is “highly similar to the reference product notwithstanding minor differences in clinically inactive components.” Although this pathway to licensing provides an expedited means to bringing biosimilar drugs to market for patients, it still requires the development and submittal of knowledge about the safety and effectiveness of the drug. Drug manufacturers are not only expected to develop the biosimilar drug, but also the analytical methods used to test the quality attributes of the drugs. These analytical methods are also used to prove ‘analytical similarity’ between the biosimilar and the reference product.
It has been stated by the FDA that this comparative “analytical characterization serves as the foundation of the biosimilar development program.” Although the use of statistical equivalence is well published and understood, the development of acceptance criteria for these studies is not. In fact, the first biologics licensing application (BLA) for a biosimilar was reviewed in January of 2015.
This talk will provide an overview of the FDA’s current thinking on comparative analytical characterization, then illustrate how JMP can be used to conduct test of statistical equivalence including the development of acceptance criteria.
- • Define biosimilar
- • Understand the need for analytical similarity
- • Know how to classify critical quality attributes into three tiers of criticality
- • Assess analytical similarity for CQAs based upon criticality
- • Understand statistical equivalence
- • Know how to conduct a test for statistical equivalence using the (FDA-recommended) sample size and variance adjustment method
- • Understand how the method is different for cases when reference lots is greater than and less than the number of biosimilar lots
- • Introduction to Analytical Similarity for Biosimilars
- • Current FDA Thinking/Approach
- • Demonstration Statistical Equivalence using Sample Size and Variance Adjustment Method (FDA-recommended approach)
- • Future Considerations