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October 15, 2018

FDA advisors endorse Celltrion’s Rituxan biosimilar

PUBLISHED : October 11, 2018 - 11:39

UPDATED : October 11, 2018 - 11:40

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[THE INVESTOR] The US FDA’s advisory committee has approved advancing the application of  Celltrion's CT-P10, a copy version to Roche’s blockbuster cancer drug Rituxan, the Korean biopharmaceutical firm said on Oct. 11.

All 16 Oncologic Drugs Advisory Committee members voted in favor of recommending that the health regulator approve the biosimilar candidate, also known as Truxima, for three of the anti-CD20 monoclonal antibody’s non-Hodgkin lymphoma indications. 




The committee was tasked with determining whether data submitted in a biologics license application for CT-P10 demonstrated similarity between CT-P10 and rituximab in terms of efficacy, safety, pharmacology, analytical similarity and immunogenicity.

The FDA often follows the advisory committee’s recommendations, but it is not obligated to do so. The agency is expected to make a final decision on Truxima by the end of November or early December.

“The totality of the evidence supports licensure, anti-CD20 therapies have really transformed B-cell lymphoma therapy and the sponsors convincingly demonstrated that CTP-10 is highly similar to US Rituxan, expect for minor components with no biologic activity. The clinical PK, efficacy and safety data are consistent with equivalence,” said ODAC panel member Thomas S. Uldrick.

The positive news for the potential regulatory pathway toward FDA marketing approval came after Celltrion resubmitted its Biologics License Applications for Truxima on May 30, following the FDA’s rejection of its first request due to production facility and manufacturing process issues.

If the FDA gives the green light to Truxima, it will be the first Rituxan biosimilar to be approved in the United States for the proposed uses.

Truxima received sales approval from the European Medicines Agency in February last year and is available in 18 European countries.

By Park Han-na (hnpark@heraldcorp.com)

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