Biosimilars: Zarxio Suffix Aimed At Preventing Interchangeable Confusion
FDA review documents suggest that pharmacovigilence was a significant, but secondary, concern in the naming decision.
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Teva’s G-CSF Product Clears FDA, Leaving Appeal Of Biosimilar Pathway Uncertain
Teva is the first company to get FDA approval of a version of Amgen’s Neupogen; one biosimilar expert questions why Teva did not switch its BLA to a biosimilar application when that pathway became available.
Biosimilar Suffix Naming Idea Trips On Dispensing Problem
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.
US FDA Holds First Hybrid Meeting With Industry
A Type A meeting was held in-person with a virtual contingent, the FDA clarified to the Pink Sheet. Several other meeting requests received were eligible, but did not seek an in-person session.