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FDA Panel Backs Rituximab Biosimilar

Jason M. Broderick and Angelica Welch
Published: Wednesday, Oct 10, 2018

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 16-0 recommending approval of the rituximab biosimilar CT-P10 for 3 of the anti-CD20 monoclonal antibody’s non-Hodgkin lymphoma indications.

If the FDA agrees with the panel’s recommendations and approves CT-P10, the biosimilar would be approved to treat adult patients with CD20-positive follicular lymphoma combined with chemotherapy in the frontline setting, followed by single-agent maintenance in responders; as a monotherapy for relapsed/refractory, low-grade or follicular, CD20+ B-cell non-Hodgkin lymphoma; and as a single agent in patients with low-grade, CD20-positive, B-cell non-Hodgkin lymphoma who do not progress following frontline chemotherapy.

ODAC was tasked with determining whether the data submitted in a biologics license application (BLA) by Celltrion and Teva Pharmaceutical Industries, the co-developers of  CT-P10, demonstrated the biosimilarity between CT-P10 and rituximab in terms of efficacy, safety, pharmacology, analytical similarity, and immunogenicity.

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