The Korea Herald

피터빈트

Celltrion confirms efficacy of Rituxan biosimilar in third phase trials

By Sohn Ji-young

Published : Oct. 13, 2016 - 17:20

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South Korean biopharma company Celltrion said Thursday that its Rituxan biosimilar has shown the same therapeutic effects as the originator drug in its third phase clinical trials.

Celltrion’s Truxima is a biosimilar drug referencing Roche’s lymphatic cancer treatment Rituxan. Biosimilars refer to cheaper, near-replicas of biologic drugs that have lost patent protection.

(Yonhap) (Yonhap)

Celltrion said that it has accumulated clinical data from Truxima’s third phase clinical trials that proves the pharmacokinetic and efficacy equivalence of Truxima and Rituxan.

The Korean drugmaker plans to present the details of its latest clinical data at the 2016 American College of Rheumotology Annual Meeting scheduled to take place in Washington D.C. next month.

The company had revealed similar data based on first phase trials at last year’s European League Against Rheumatism Annual Meeting in June last year.

Looking ahead, Celltrion appears to be drawing closer to commercializing its Rituxan biosimilar in Europe faster than its competitors. It submitted Truxima to the European Medicines Agency for sales approval in October 2015.

“We are expecting to reap ‘first mover’ advantages from being the first company to introduce a Rituxan biosimilar in the global market,” Celltrion said in a statement. “We plan to focus our efforts on commercializing Truxima as swiftly as possible.”

Meanwhile, Novartis-owned Sandoz also submitted its own Rituxan biosimilar to the EMA for approval in May this year. Pfizer and Amgen are wrapping up third-phase clinical trials of their own Rituxan biosimilars as well.

Rituxan is the world’s third best-selling biologic drug in the world, having generated worldwide sales of $7.3 billion last year.

By Sohn Ji-young (jys@heraldcorp.com)