June 27, 2019

Celltrion’s Truxima gets sales approval in Canada

PUBLISHED : April 11, 2019 - 14:53

UPDATED : April 11, 2019 - 14:53

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Celltrion announced on April 11 that it has obtained marketing authorization from Health Canada for Truxima, its biosimilar for treating non-Hodgkin’s lymphoma.

Truxima references Roche’s Rituxan (rituximab), which currently posts around 250 billion won ($220 million) in annual sales on average in Canada.

“We will try to enter the market as soon as possible so that Canadian patients can also use our high quality biosimilar at a reasonable price,” a Celltrion official said in a statement.

Celltrion Healthcare, which is in charge of Celltrion’s sales overseas, will discuss with its partner TEVA and decide on the specific date of launch.

In November last year, Celltrion also received marketing authorization from the US Food and Drug Administration for Truxima. It was the first biosimilar based on Rituxan to be approved by the US health regulator.

As the company is receiving approvals overseas as planned, industry insiders are expressing a positive outlook for Celltrion’s performance this year.

“With Remsima SC getting approval in Europe and Truxima in the US, an improvement in sales performance is expected in the second and third quarter this year,” Kium Securities’ analyst Huh Hae-min said in her report.

In 2014, Celltrion had obtained marketing authorization from Health Canada for Remsima, its biosimilar of Johnson & Johnson’s autoimmune disease therapy Remicade, which is being sold by its partner Pfizer.

By Song Seung-hyun (

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