“Celltrion is currently wrapping up steps to add 50,000 liters of expanded capacity to its first plant based in Songdo, Incheon. At this point, we’d like to clarify that nothing has been decided on the location of the third plant,” Celltrion said in a statement.
“We plan to carefully consider all options, including Korea and foreign locations, to select the best location where Celltrion’s biosimilars can achieve the highest cost competitiveness.”
|Celltrion headquarters (Park Hyun-koo/The Korea Herald)|
The remarks came in response to a local news report that claimed, citing sources in the investment banking industry, that Celltrion had confirmed Singapore as the final location for its third plant, and was preparing to begin construction within next year.
Celltrion primarily focuses on developing biosimilars -- cheaper, biologically similar copies of live cell drugs whose patents have expired. Its commercial products currently include biosimilars of blockbuster biologics including Remicade, Herceptin and Rituxan.
The firm now has two plants in Songdo, the first with a production capacity of 50,000 liters and the second at 140,000 liters. To address rising supply needs, Celltrion had announced that it would build a third plant with a capacity of 360,000 liters.
According to Celltrion, the company has signed a production deal of 80,000 liters with a biologics contract manufacturing organization, which will begin commercial production after validation procedures are completed.
The firm is also reviewing another CMO production deal for 90,000 liters, to ensure a stable supply of biosimilars to meet market demands, it said.
Celltrion’s Remicade-referencing biosimilar, Remsima, is being sold in the US and Europe. The firm’s other biosimilars, Truxima and Herzuma, referencing Rituxan and Herceptin respectively, have been launched in Europe.
Truxima and Herzuma are also drawing closer to obtaining approval by the US Food and Drug Administration. The FDA’s marketing approvals are expected to come within this year, according to Celltrion.
This week, Celltrion said the US FDA had approved the firm’s production facility in Songdo after reinspection, clearing an issue that had been hindering the approval of Truxima and Herzuma.
By Sohn Ji-young (firstname.lastname@example.org)