South Korean biopharma company Celltrion said Monday that the US Food and Drug Administration has accepted for review the firm’s biologics license application for Herzuma, its cheaper biosimilar copy of Roche’s blockbuster anticancer drug Herceptin.

Celltrion submitted Herzuma to the US FDA in May. The US regulator is slated to announce its approval decision in the first half of 2018, according to the Korean drugmaker.

Developed by Roche-owned Genentech, Herceptin is a monoclonal antibody drug primarily used to treat metastatic breast cancer. It is one of Roche’s top-selling drugs, having generated around 7.9 trillion won ($7.4 billion) in sales globally in 2016, around half of which came from the US market. 

The upcoming wave of Herceptin-referencing biosimilars is expected to eat into Roche’s sales of the original drug.

Celltrion is not alone in its efforts to launch a Herceptin-referencing biosimilar in the US. Mylan and its partner Biocon are poised to become the first to introduce a Herceptin-referencing biosimilar in the US.

The two companies announced in early July that the FDA Oncologic Drugs Advisory Committee unanimously recommended its Herceptin biosimilar for approval, which signals imminent official approval.

Herzuma is Celltrion’s third drug to seek entry into the US market. The company obtained the US FDA’s approval for its Remicade-referencing biosimilar Remsima in April. It has been selling the drug in the US under the name Inflectra since November 2016 via its marketing partner Pfizer.

Celltrion also filed Truxima, a biosimilar referencing Roche’s Rituxan, with the US FDA in June. It is expecting the US regulator to grant approval for the drug in the first half of 2018, like Herzuma.

“We have filed all three of our first-mover products for approval by the US FDA. Once Herzuma and Truxima enter the US, we will be effectively tapping into a drug market worth more than 8 trillion won,” Celltrion said in a statement.

Once approved, Celltrion’s Herzuma and Truxima will be marketed and sold in the US via its marketing partner Teva Pharamaceutical Industries.

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