Remsima (Infliximab)

Remsima (infliximab) is an anti-inflammatory therapy, developed by Celltrion Healthcare and approved to treat ankylosing spondylitis (AS) and other inflammatory diseases. A biosimilar, it is also marketed under the brand names Inflectra and Flammegis.

How Remsima works

In AS, joints between the vertebrae in the spinal column become inflamed and cause pain. As the disease progresses, this inflammation can lead to new bone tissue forming between the joints, causing the vertebrae to fuse together.

Remsima is used to reduce inflammation, so as to reduce pain and the progression of AS. It consists of a monoclonal antibody called infliximab.

Monoclonal antibodies are specialized proteins that are designed to recognize and attach to specific molecules. Infliximab recognizes and attaches to a molecule called tumor necrosis factor-alpha (TNF-alpha), which is involved in inflammation. Patients with AS have high levels of TNF-alpha in their body. When infliximab binds to TNF-alpha, it deactivates it, preventing it from causing inflammation.

Remsima is a “biological product,” which means that it is produced using biotechnology — in this case, recombinant DNA technology. In this process, cells kept in the laboratory, such as bacterial cells, are genetically altered so that they are capable of producing the desired molecule — here, infliximab. These genetically altered cells essentially become tiny factories for producing the compound of interest, which is then harvested from the cells and purified.

Remsima is classified by the U.S. Food and Drug Administration (FDA) as a “biosimilar,” meaning that this biological product was determined to be highly similar to a therapy already approved by the FDA. The biosimilar classification helps speed FDA approval and reduce the treatment’s cost. Remsima is a biosimilar of Remicade, approved to treat ankylosing spondylitis in 2004.

Remsima in clinical trials

An observational clinical trial (NCT02557308) evaluating the safety and effectiveness of Remsima as an AS treatment is underway in Korea. About 1,000 adult patients with active AS will be followed for five years to compare Remsima’s safety, as measured by “events of special interest” in patients using it, with patients using other anti-TNF-alpha treatments, including Remicade. The study is expected to conclude in 2026.

A previous, shorter Phase 4 trial (NCT02148640) in Norway reported in an article published in the journel Lancet that switching from Remicade to Remsima was safe, and the two were of similar effectiveness. More than 450 patients with a variety of inflammatory diseases, although not ankylosing spondylitis, took part in this 52-week randomized, double-blind and parallel-group study that concluded in January 2017.

Additional information

Remsima was approved for use in the E.U. in 2013 and in the U.S. in 2016. It is the first biosimilar monoclonal antibody to be approved by both the FDA and the European Medicines Agency (EMA).

Common side effects associated with Remsima’s use include viral infections such as colds, flu, and cold sores, as well as headache and nausea.

Remsima is not recommended for patients who have had allergic reactions to infliximab or any of its other ingredients. Patients who have heart failure, tuberculosis or other serious infections, should also not take Remsima.


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