Celltrion eyes the market share of Remsima SC, the world’s first subcutaneous formulation of biosimilar infliximab, surging to 50 percent from current 8 percent in five major European markets over the next two to three years.

The market share of Remsima SC is expected to grow fast amid the easing of pandemic restrictions as patients prefer self-administration at home to save time and cost from hospital visits for injection on top of its better treatment outcomes, Celltrion Healthcare Marketing Director Choi Byung-seo said on Thursday.

Choi’s comment comes after positive results of a Phase 3 study of Remsima SC presented at the 2022 European Association for Rheumatology (EULAR), with more treatment benefits versus infliximab intravenous (IV) in the treatment of rheumatoid arthritis (RA) patients.

In the study involving 343 RA patients, patients in the Remsima SC arm showed a statistically significant difference in most clinical indicators including lower disease activity (LDA) and remission rate versus the infliximab IV arm at 30 weeks plus better efficacy in those who switched from IV to SC. The results meet the treatment goals set by EULAR’s RA treatment guidelines.

EULAR sets the treatment goal of reaching LDA and remission rate within 30 weeks for RA treatment, which recommends considering a different regimen for patients when the goal is not met.

Remsima SC is expected to be launched in the United States in early 2024. Celltrion is targeting the entire market of anti-TNF-α treatments worth $50 billion for Remsima SC, about five times larger than the Remsima target market. Subcutaneously administered Humira and Enbrel are key rivals in this sector.

Celltrion is also building a direct sales network in the U.S. to improve profitability of its biosimilar products. The ongoing merger of three Celltrion Group companies will bring more flexibility in drug pricing to increase competitiveness, Choi added.

By Chung Seul-gi and Minu Kim

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