GPhA Gets Its Second Choice On Biosimilar Naming
Preemptive compromise proposing suffix on nonproprietary name offered at private meetings with FDA appear to have carried the day.
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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.
AstraZeneca/Sanofi’s Nirsevimab Nears US FDA Approval After Overwhelmingly Positive Adcomm
When patients should receive the RSV prevention treatment was the subject of much debate even as the Antimicrobial Drugs Advisory Committee voted nearly unanimously that it should be approved for infants and neonates.
AstraZeneca’s Nirsevimab: US FDA Wants Input On How It Would Fit With Pediatric RSV Vaccines
Proposed RSV prevention treatment for infants and neonates showed efficacy with few safety concerns, but with pediatric vaccines in development, FDA wants the Antimicrobial Drugs Advisory Committee to discuss what data would be needed to determine appropriate use in vaccinated infants and mothers.