Biosimilars May Drift, But What Should FDA Do About It?
Executive SummaryAnother balance FDA likely will have to strike in its emerging biosimilars pathway is letting innovators improve and update manufacturing processes while ensuring similar biologics can remain similar to their reference products.
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American Pharmacists Association tells FDA during biosimilar guidance hearing that using suffixes to create unique names will be problematic. FDA may be leaning toward the unique names, saying published literature indicates adequate safety tracking is not possible without them.
As the agency and stakeholders gear up for public hearing, Sandoz argues that since Europe has not addressed interchangeability, FDA could step to the forefront by focusing on it as part of implementing the U.S. biosimilar pathway.
The limited discussion of interchangeability in FDA’s initial biosimilar draft guidances has left some stakeholders clamoring for more details. Others say the agency’s demand for a “higher standard” of evidence to show interchangeability is misplaced and will inhibit use of the 351(k) pathway.