Celltrion’s Rituximab Biosimilar Has Easy US FDA Panel Ride Despite Questions About Narrow Label
Oncologic Drugs Advisory Committee says totality of evidence supports licensure of CT-P10 for three lymphoma indications, but panelists question what additional data would be needed to eventually get Rituxan’s other approved uses, which were carved out for patent and exclusivity reasons, onto the biosimilar’s label.
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Sue Lim, who serves as director of scientific review staff of the US FDA's Therapeutic Biologics and Biosimilars Staff, will be leaving the agency at the end of February to start an independent consulting firm.
A departure date has yet to be determined for the associate director of therapeutic biologics, who helped negotiate and implement the biosimilar user fee program.
As the year end approaches, Scrip wraps up what major events made headlines in the South Korean pharma/biotech sector in 2018.