Celltrion and Teva announced Wednesday that an FDA advisory committee unanimously backed authorisation of Truxima, a biosimilar version of Roche's cancer drug Rituxan (rituximab), for certain patients with CD20-positive, B-cell non-Hodgkin's lymphoma. The recommendation comes after the FDA had declined to approve Truxima in April due to problems related to manufacturing processes at a Celltrion facility.
The concerns identified at the facility, which is located in South Korea, were cited in a warning letter issued to Celltrion in January. The company announced last month that the FDA had cleared the site following a re-inspection.
Celltrion and Teva completed their resubmission of Truxima for FDA approval in May. The companies agreed to jointly commercialise the biosimilar in the US and Canada under the terms of a 2016 partnership.
In January, Celltrion filed lawsuits in US district court against Roche's Genentech unit, seeking to invalidate patents covering Rituxan, as well as Roche's breast cancer drug Herceptin (trastuzumab). In the complete response letter for Truxima earlier this year, the FDA had also declined to approve Celltrion's Herzuma, the company's proposed biosimilar to Herceptin.
Truxima was cleared in Europe in 2017, marking the first authorisation of a biosimilar monoclonal antibody for an oncology indication anywhere globally. Meanwhile, Herzuma was granted EU approval this past February.
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