[THE INVESTOR] Celltrion Healthcare said on June 8 that a subcutaneous formulation of its anti-inflammatory therapy Remsima, or CT-P13, demonstrated efficacy and safety comparable to the Remsima intravenous formulation up to week 30 in patients with active Crohn’s disease in phase 1 clinical studies.

Remsima is Celltrion’s biosimilar version to Johnson & Johnson’s blockbuster drug Remicade. 

The results, which were announced at Digestive Disease Week 2008 in the US, demonstrated the potential of Remsima SC to enhance the treatment options available for patients treated with infliximab.

“Together with CT-P13 IV, CT-P13 SC marks a significant milestone for Celltrion Healthcare and our partners. This kind of innovation will enable us to differentiate our portfolio and provide a more convenient and accessible treatment administration option to patients with chronic conditions like inflammatory bowel diseases in the US,” Celltrion Vice Chairman Kim Hyoung-ki said.

The SC version offers self-administered pen type option to patients with mild conditions.

The Incheon-based biopharmaceutical firm plans to bring the new under-the-skin injection formula to global markets next year to solidify its foothold in the anti-tumor necrosis factor alpha market, in which patients with inflammatory bowel disease account for some 60 percent. The IV formulation has already taken on the original drug in terms of market share in Europe. It was launched in the US in late 2016.

“With the diversified product portfolio, we plan to make Remsima a global blockbuster drug by bolstering its market share in the global anti-tumor necrosis factor alpha market worth 35 trillion won (US$32.58 billion),” the company said.

Celltrion Healthcare said it expects the new version to encompass patients with inflammatory bowel disease who are being treated with other anti-tumor necrosis factor alpha therapies including Humira, Enbrel as well as the original Remicade.

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