FDA Panel Urges Approval Of Celltrion’s Biosimilar Of Blockbuster Cancer Drug

October 11, 2018
Roche’s blockbuster blood cancer drug Rituxan could soon face competition if FDA follows its advisory panel’s call Wednesday for approval of Celltrion and Teva’s CT-P10 biosimilar to treat non-Hodgkin’s lymphoma. The unanimous vote by the Oncologic Drugs Advisory Committee came after Celltrion agreed earlier this year to change its manufacturing process due to FDA concerns. The vote likely sets up Celltrion as the first biosimilar competitor for Rituxan, which comes off patent this year. FDA usually follows its advisory committee...

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