April 1, 2020
In an article published in BioPharm International, Columbia partner Jennifer Mallory discusses the biosimilars interchangeability and the many evaluation and testing requirements that are needed to ensure compliance and safety.
“These are designed to ensure that the biosimilar produces the same clinical result as the approved biologic in any patient and that the safety and efficacy risks arising from switching between the approved biologic and the biosimilar are not greater than the risk of using just the approved biologic,” Mallory says.
An important theme in the guidance, Mallory emphasizes, is that FDA is not suggesting that there is a one-size-fits-all approach for demonstrating interchangeability. Rather, the agency used the guidance to confirm that demonstrating interchangeability is complex, much like the complex molecules involved. “Thus, FDA noted in the guidance that the ‘data and information necessary to support a demonstration of interchangeability need to be considered on a case-by-case basis.’,” Mallory says.
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