FDA, WHO Biosimilar Naming Proposals Take Shape
FDA appears to be awaiting HHS clearance of its guidance, while WHO has released its proposal for public comment.
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Biosimilar Guidances Expected In ‘Near Future,’ But Unnecessary, FDA Says
Naming and labeling questions will likely be resolved with agency actions on pending biosimilar applications.
Sandoz’s Biosimilar Filing Is Culmination Of Paradigm Shift In FDA Drug Review
FDA clinical reviewers moved from traditional “new drug” review mode to determining the evidence needed to demonstrate a follow-on product is highly similar to the reference biologic, Sandoz exec says, describing firm’s interactions with FDA on its filgrastim 351(k) application.
GPhA And Actavis Divorcing: Biosimilars Behind The Rift
Actavis, the hybridizing generics giant that once helped keep GPhA together, now appears to be splitting off in a dispute over state substitution strategy.