June 25, 2018

Celltrion to seek US approval for Truxima, Herzuma soon

PUBLISHED : June 13, 2017 - 15:28

UPDATED : June 13, 2017 - 15:36

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[THE INVESTOR] Celltrion plans to submit biologics license applications for its copy versions of rituximab and trastuzumab to the US regulator over the next few months to begin sales in the US market as early as 2018, a company official said on June 13.

Following the firm’s launch of Remsima, biosimilar copy of Johnson & Johnson’s Remicade, in the US last year, Truxima and Herzuma -- referencing Roche’s lymphatic cancer drug Rituxan (rituximab) and breast cancer therapy Herceptin (trastuzumab) -- are gearing up to enter the market.

“The biologics license applications for Truxima and Herzuma will be filed either in summer or fall,” spokesperson Lee Gun-hyuk told The Investor. An application is a request for permission to market the biologics drugs.

A more detailed timeline has not been firmed up, as the firm is in talks with the US Food and Drug Administration, he said.

Earlier this year, Celltrion said it would seek regulatory approval for the two biosimilars in the US by June.

Biosimilars refer to cheaper near replicas of biologic drugs whose patents have expired.

The US patents for the original drugs Rituxan and Herceptin expire in 2018 and 2019, respectively.

The company expects to win US sales approval in late 2018 or early 2019, meaning Truxima won’t face any patent problem.

“We are working on intellectual property rights issues of Herceptin to move up the launch date before it loses patent protection in 2019,” Lee said.

Celltrion has filed applications with the US Patent and Trademark Office challenging five patents of Herceptin held by Roche-owned Genentech from the course of Feb. 20 to March 24.

The patents in question concern Herceptin’s administration methods as well as process of treating breast cancer using a regimen that includes the drug, according to the drug maker.

Once approved, Truxima and Herzuma are slated to be sold in the US via Celltrion’s US marketing and sales partner Teva Pharmaceutical Industries, the world’s largest maker of generic drugs.

By Park Han-na (

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