Celltrion "Reconfirmation of Long-term Safety and Efficacy of Remsima"... Poster Presentation at Asia-Pacific Conference

[Asia Economy Reporter Lee Gwan-joo] Celltrion announced on the 5th that it will present a poster on the safety confirmation and improvement of efficacy indicators from a post-marketing long-term administration and efficacy observation study of Remsima at the Asia Pacific League of Associations for Rheumatology (APLAR).

APLAR is an international academic conference where experts in rheumatic diseases gather to share the latest insights on diagnosis, treatment, and clinical practice. It will be held in Hong Kong from the 6th to the 9th of this month.

Celltrion conducted a post-marketing study (PMS) in Thailand, administering Remsima for 46 weeks to 30 patients with ankylosing spondylitis (AS), rheumatoid arthritis (RA), and psoriatic arthritis (PsA). This PMS focused on evaluating safety, including infections, tuberculosis, infusion-related reactions (such as anaphylaxis), liver diseases, and cancer incidence related to Remsima administration. Additionally, efficacy indicators comparing patients' conditions before and after administration were assessed. The study results confirmed both the safety of Remsima administration and improvements in efficacy indicators.

Remsima obtained marketing authorization from the Ministry of Food and Drug Safety in 2012, followed by approval from the European Medicines Agency (EMA) in 2013 and the U.S. Food and Drug Administration (FDA) in 2016. According to pharmaceutical market research firms and Celltrion Healthcare, Remsima holds a market share of 53.6% in Europe and 31.7% in the United States. It is also widely used as a treatment for autoimmune diseases in Asia, including South Korea.

The subcutaneous injection form of Remsima, RemsimaSC, which improves the convenience of use compared to the intravenous (IV) form, is currently rapidly increasing its market share in Europe. In the United States, an application for approval is pending with the FDA under the new drug approval process.

A Celltrion official stated, "Through the PMS results conducted in Thailand, we have once again demonstrated the safety and efficacy of Remsima, securing stronger evidence to promote its prescription as a treatment. We will do our best to ensure that Remsima is widely used not only in Europe and the United States but also in the Asian autoimmune disease treatment market through efforts to expand clinical evidence such as conducting PMS by country."

This content was produced with the assistance of AI translation services.