PET Drug Development Streamlining Proposal Gets Thumbs Up From US FDA Panel
New approach that would eliminate the need for animal dosimetry data for some positron emission tomography drugs draws advisory committee support, although some panelists raise concerns about limited existing data and longer half-life for copper 64, one of the six radionuclides under consideration.
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An advisory committee will discuss whether the agency may consider human studies sufficient to allow reasonable radiation absorbed dose calculations for new PET drugs containing one of six radionuclides in the absence of drug-specific animal dosimetry data.
Pink Sheet’s Drug Review Profile explores Amgen’s Wezlana, an interchangeable biosimilar to Janssen’s Stelara. FDA determined late in the review that switching studies generally would not be needed for interchangeable ustekinumab products, prompting Amgen to seek the designation.
Assigning different suffixes to the prefilled syringe and intravenous formulations of Amgen’s ustekinumab biosimilar could create confusion and would not further the goals of the naming convention, the FDA said in explaining why it departed from its January 2017 final guidance.