Celltrion to launch SC infliximab biosimilar in U.S.

Zymfentra [Courtesy of Celltrion Healthcare]

Celltrion Healthcare announced on Thursday that it would bring Zymfentra (infliximab-dyyb), the world’s first and only subcutaneous infliximab product, to the U.S. market in February 2024 through its subsidiary, Celltrion USA.

Zymfentra represents a transformation of the intravenous autoimmune disease treatment, Remsima, into a more convenient subcutaneous form. The U.S. Food and Drug Administration (FDA) granted novel drug approval for Zymfentra in October 2023, and the company has swiftly confirmed local supply schedules within four months of the approval.

Celltrion Healthcare already provided relevant clinical data to many pharmacy benefit managers (PBMs) to give Zymfentra a boost in the market. PBMs play an essential role in managing prescription drug benefit plans for employers and health insurers, and negotiations are currently underway to list Zymfentra as a preferred drug within their formularies. The company anticipates some PBMs agreeing to include Zymfentra in their formularies around the time of its launch.

Celltrion Healthcare also plans to expand its marketing activities for Zymfentra to target healthcare professionals specializing in autoimmune diseases within the United States. Starting in January 2024 with the Crohn’s and Colitis Congress (CCC), the company aims to actively participate in major conferences such as the Digestive Disease Week (DDW) in May, the American College of Gastroenterology (ACG) in October, and the American College of Rheumatology (ACR) in November. The company will collaborate with major patient advocacy groups in the United States to develop diverse programs supporting patients prescribed with Zymfentra.

The company also intends to bolster its local workforce responsible for commercial activities for Zymfentra. By January 2024, Celltrion Healthcare plans to double its sales force dedicated to Zymfentra and more than triple its promotional and marketing staff.