Celltrion's Zymfentra / Courtesy of Celltrion

Celltrion, a major Korean pharmaceutical company, has developed a new autoimmune disease treatment device known as Zymfentra. It is the company's first self-developed medical product that will debut in the United States, and is on its way to becoming a major success story in the North American country's medical industry, according to the company, Monday.

Using the subcutaneous injection device that has already gained recognition in Europe under a different name, Remsima SC, Celltrion said it will leverage the accomplishment to take the biggest share of the U.S. tumor necrosis factor (TNF)-alpha inhibitor market.

After earning approval from the U.S. Food and Drug Administration last year and entering the country's market in March, Zymfentra started gaining the trust of market experts. Being able to administer infliximab — a medication used to treat numerous autoimmune diseases — through injection, the device has earned recognition among U.S. pharmacy benefit managers (PBM) groups. Express Scripts, one of the major US PBMs with almost 100 million registered members, has recently listed Zymfentra under its "preferred drugs" category in its formulary.

The achievement means huge leverage for Celltrion. Together with smaller PBMs in the U.S. with which the company previously signed supply deals for its new product, Zymfentra becomes available to some 40 percent of all medical insurance subscribers in the U.S.

According to global medicinal product market analyst IQVIA, the U.S.' TNF-alpha inhibitor market (including infliximab) was worth $51.2 billion last year, the biggest in the world. Within the market, Zymfentra first targeted treating inflammatory bowel disease (IBD), which accounted for a medicinal market worth $10.3 billion.

To maintain Zymfentra's market presence in the U.S., Celltrion last month registered the product's patent at the U.S. Patent and Trademark Office. The company said the measure has boosted the product's market dominance far ahead of its rival brands by securing its exclusive rights in the U.S. market until 2040.

"With its proven efficacy and improved convenience in application, Zymfentra will treat a broader range of patients in the U.S.," a company official said. "It is Celltrion's goal to lead the global market for biosimilars and new drugs."