Celltrion said it has commenced the first shipment of Zymfentra, the world’s first subcutaneous form of infliximab, to the U.S. targeting autoimmune diseases. 

The company announced that the initial shipment batch was airlifted today to Atlanta, U.S., with plans to complete three shipment phases by early March. This initial supply is expected to be available for market distribution by mid-March after completing import customs and local logistics processes, including delivery to wholesalers.

Zymfentra, referencing the original drug Remicade, developed by Janssen, is designed to treat a range of conditions, including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, adult Crohn's disease, and adult ulcerative colitis. Unlike the original medication, Zymfentra is administered subcutaneously, simplifying patient compliance.

According to the company, Zymfentra represents a significant innovation, transforming the traditional intravenous infliximab, Remsima, into a subcutaneous injection.

This change was developed in response to the demands of healthcare professionals and patients for more convenient treatment options. The FDA approved Zymfentra as a new drug in October last year, highlighting its potential to revolutionize treatment methodologies.

Already approved in over 50 countries, including Europe and Canada, Zymfentra has proven its efficacy and convenience, suggesting a high success potential in the U.S. Since its launch in Europe in 2020, Zymfentra has received acclaim from medical professionals and patients alike, leading to significant market expansion.

According to IQVIA, a market research firm, Zymfentra achieved a 20 percent market share in the major five European countries (EU5) by the third quarter of last year, with a combined market share with Remsima, the IV formulation, reaching 72 percent.

Celltrion has been preparing for direct sales marketing in the U.S. through its American subsidiary, following FDA approval. Given the 20-year track record of infliximab use in the U.S., emphasizing the safety and efficacy of the drug, along with the convenience of self-administration in the challenging U.S. healthcare environment, forms a core part of their strategy.

“This initial shipment marks the beginning of Zymfentra's supply to the U.S. market,” a company official said. “As clinician and patient excitement for Zymfentra continues to grow, we will be finalizing a number of launch marketing activities, including patient support programs, to ensure that U.S. patients receive the therapeutic benefits of Zymfentra.”