Celltrion Pharm, the generic arm of Celltrion, announced on Feb. 27 that it has decided to inject 58.2 billion won for establishing its Remsima SC production facility at its plant in Cheongju, North Chungcheong Province.
Remsima SC is a subcutaneous version of Remsima, its biosimilar of Johnson & Johnson’s autoimmune disease therapy Remicade.
The company said it will finish injecting the funds before end-2020.
“The funding will meet the expected rising global demand for Remsima SC,” a Celltrion Pharm official told The Investor. “Our factory in Songdo did not have room for a Remsima SC production line, so we have been using foreign contract manufacturing organizations to produce the drug. After we launch the facility, we expect to gain some cost competitiveness and more profitability.”
According to Celltrion Pharm, its factory in Cheongju, which was established in 2015, is considered as a key site for global expansion. It received Current Good Manufacturing Practice certificate from the US Food and Drug Administration, while European Medicines and Healthcare products Regulatory Agency has also finished conducting a due diligence of the site.
Meanwhile, Celltrion in November last year applied to European Medicines Agency for marketing authorization of the subcutaneous version of Remsima. The company is expecting to receive approval in the second half of this year.
By Song Seung-hyun (firstname.lastname@example.org)