Heath Rushing, Co-Founder and Principal, Adsurgo
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created an abbreviated pathway for licensing 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 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 a test of statistical equivalence including the development of acceptance criteria.
