Celltrion Pharm has pledged KRW 58.2 billion won ($51 million) to establish a production site for Remsima SC, a subcutaneous version of its Remicade biosimilar.
Korean drugmaker Celltrion has achieved regulatory success for its biosimilar of J&J’s Remicade (infliximab) across several key markets and is now looking to receive approval and launch a subcutaneous version of the immunosuppressive monoclonal antibody.
To prepare for launch, the firm has committed KRW 58.2 billion won ($51 million) to its site in Cheongju, South Korea to establish a production line for the product. The firm’s other biosimilar production lines are located at its Incheon, Songdo site, run by Celltrion, rather than Celltrion Pharm, the generic arm of the company.
“Per the lack of the space availability and workforce at the Incheon site, Celltrion Pharm has been considered as an appropriate site for efficient and integrated PFS [Pre-filled Syringes] production process for Remsima SC,” spokesperson Gunhyuk Lee told us.
He confirmed the project was a separate investment to the planned site expansion at the Songdo site, confirmed earlier this year. In January, the firm said a third 120,000 L biologics plant would be built at the Songdo plant after assessing several overseas locations.
Celltrion launched Remsima in Europe in 2013. In the US, the product is known as Inflectra and is exclusively licensed by Pfizer. Since then, several other infliximab biosimilars have been approved and launched in both Europe and the US.
Sol Yoon, a spokesperson from Celltrion’s marketing and distribution affiliate Celltrion Healthcare, told us Remsima SC will offer an advantage over the reference product and the growing competition.
“Remsima SC is the only dual formulation among the TNF-a inhibitors which means Remsima SC will improve drug survival through line extension with Remsima IV. Patients can start treatment with Remsima IV and then maintain with Remsima SC,” he said.
“Also, we can target patients already being treated with infliximab, as well as patients using SC version of other TNF-alpha in hibitors incluing Humira and Enbrel which will expand the target market to the whole TNF-alpha inhibitors from infliximab. “
The subcutaneous version has been submitted for review to the European Medicines Agency (EMA), and if approved will be sold directly in the region by Celltrion, the Korea Herald reported in January.
“Celltrion hasn’t submit the application for Remsima SC to the US FDA yet,” Lee told us, adding it is too early to talk about the firm’s marketing strategy.