Boditech Med said Monday that it has obtained export approval for AFIAS Adalimumab, a therapeutic drug monitoring (TDM) diagnostic kit that measures the adalimumab level in the blood, used for autoimmune treatment.

AFIAS Adalimumab is a point of care diagnostic tool measuring the adalimumab level in the blood, which is optimized for personalized medicine by allowing medical workers to check the patient's condition right before administering the antibody treatment.

Adalimumab is the active ingredient of AbbVie's Humira, which treats rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, and ulcerative colitis. The drug records more than 20 trillion won ($17 billion) sales annually worldwide.

Humira's patent expired in 2018 in Europe, and it will also pass in the U.S. next year. As a result, global biosimilar developers, including Celltrion, Samsung Biologics, and Amgen, have been speeding up their entry into the market.

The existing products were mostly enzyme-linked immunosorbent assay (ELISA) that required two to three weeks after taking the blood sample from the patient.

However, the new test kit commercialized by Boditech Med can see the test result within 10 minutes using whole blood on-site, and it shows similar performance compared to the existing ELISA product.

"We consider the TDM diagnostic market for customized therapy as our next growth engine in the antibody treatment market," a Boditech Med official said. "We launched two types of TDM diagnostic products for Infliximab, an autoimmune treatment, in December and planned to begin the supply in earnest."

The official added that the company is also developing a TDM diagnostic kit for various autoimmune and chemotherapy and plans to build more plants to double its manufacturing capacity.