FDA Approves Celltrion and Teva’s Biosimilar to Rituxan

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FDA has approved Truxima (rituximab-abbs), a biosimilar to Roche’s anti-cancer biologic, Rituxan (rituximab).

Celltrion and Teva Pharmaceutical Industries announced on Nov. 29, 2018 that FDA approved Truxima (rituximab-abbs), a biosimilar referencing Roche’s anti-cancer biologic, Rituxan (rituximab). Rituxan is Roches’ top-selling drug with 2017 sales of approximately CHF 7.4 billion (US$ 7.5 billion).

According to Celltrion, Truxima is the first rituximab biosimilar to be approved in the United States. The drug was approved for three indications: as a single agent to treat relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non–Hodgkin’s lymphoma (NHL); in combination with chemotherapy for previously untreated follicular, CD20-positive, B-cell NHL and as single-agent maintenance therapy for the same condition in patients achieving a complete or partial response to a rituximab product; and as a single-agent for treating non-progressing, low-grade, CD20-positive, B-cell NHL.

“Truxima is the very first rituximab biosimilar to be approved in the United States for three non-Hodgkin’s lymphoma indications and may help provide greater accessibility for patients,” said Woosung Kee, CEO of Celltrion, in a company press release.


Celltrion and Teva entered into an exclusive partnership in October 2016 to commercialize Truxima in the US and Canada. The two companies have reached a settlement agreement with Genentech, a Roche company, including entry terms. The terms and conditions of the agreement were not disclosed.

Source: Celltrion