Teva-partnered Celltrion biosimilar scores FDA adcomm recommendation for a second shot at shaking up Roche's Rituxan franchise
After repeated run-ins with the FDA in the past few months regarding site inspections and biosimilar filings, Celltrion might finally be turning things around with an unanimous thumbs up for its Rituxan copycat from the FDA advisory committee.
All 16 oncologic drug experts on the panel endorsed CT-P10 for three of the eight indications on Rituxan’s label — as either standalone or maintenance therapy for B-cell non-Hodgkin lymphoma.
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