Celltrion’s Rituxan biosimilar gets unanimous backing from FDA committee

pharmafile | October 11, 2018 | News story | Sales and Marketing FDA, Oncologic Drugs Advisory Committee, Rituxan, Roche, Truxima 

FDA approval looks to be in reach for Celltrion, as an advisory committee for the US regulator voted unanimously to recommend Truxima, its biosimilar version of Roche’s Rituxan (rituximab), in the treatment of cancer.

All 16 members of the Oncologic Drugs Advisory Committee (ODAC) backed the decision, and while the FDA is not beholden to the recommendation, it is thought that it could greatly influence its final verdict, which is expected by the end of this year.

Truxima has been under review since June, following its resubmission in May. If it were to secure approval, it would be authorised for use in the same inications as its reference product, including rheumatoid arthritis and non-Hodgkin’s lymphoma.  

“We welcome the ODAC’s recommendation. If taken up by the FDA, Truxima will be the first Rituxan biosimilar to be approved in the United States for the proposed uses,” remarked Celltrion CEO Kee Woo-sung. “The development of biosimilars is of great importance in the field of oncology, and has the potential to increase accessibility to treatments for the patients.”

Matt Fellows

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