[THE INVESTOR] Celltrion took a step closer to introducing its second biosimilar product in the US with the drug regulator accepting its biologics license application for Truxima, its copy version of Roche’s blockbuster treatment Rituxan, it announced on June 29.

The drug is similar to the original drug, and used to treat non-Hodgkin’s lymphoma and chronic lymphocytic leukemia. The firm said it hopes to get approval in the first half of 2018. 

“We expect to provide high quality health care benefits to US patients if Truxima gets the nod from US Food and Drug Administration. This follows Inflectra, the first antibody biosimilar that was launched in the US last year,” Celltrion CEO Kee Woo-sung said in a press release.

If approved, Truxima will be its second biosimilar sold in the US after Inflectra, referencing Janssen Biotech’s Remicade, whose sales have shown steady growth.

Truxima is already available in the European Union as the first ever Rituxan biosimilar that was approved by the European Medicines Agency in February.

Celltrion is seeking to become the first firm to launch the Rituxan biosimilar in the US as other drug makers such as Novartis-owned Sandoz also plan to filed their versions with the FDA to capture market share of the original drug, which posted US$7.05 billion in global sales in 2016.

Teva, which signed a US$160 million worth license deal with the Korean biopharmaceutical firm for North America last year, will sell the drug after clearing regulatory hurdles.

By Park Han-na (hnpark@heraldcorp.com)