'Celltrion's Zimpendra, Imminent US Launch, First Shipment Boards Flight to America'

Celltrion announced on the 28th that it will begin shipping the initial batch of Jimpendra (the U.S. product name for RemsimaSC), a new drug for autoimmune disease treatment, ahead of its U.S. launch next month.

Celltrion's new drug for autoimmune disease treatment, Jimptentra [Photo by Celltrion]

The initial shipment of Jimpendra will be sent to the U.S. in three batches from today until early next month. The first shipment departs today for Atlanta, U.S. The shipped products will go through local logistics procedures such as import customs clearance, transportation, and warehousing at wholesalers and retailers, with market supply expected to begin around mid-next month.

Jimpendra is the same product as RemsimaSC, which is a subcutaneous injection formulation of the biosimilar drug Remsima (active ingredient infliximab) that was originally developed as an intravenous injection. Reflecting the demands of medical staff and patients heard firsthand by Celltrion Group Chairman Seo Jung-jin during his site visits, it is the first and only infliximab-based drug developed as a subcutaneous injection. Unlike intravenous drugs that must be administered by medical professionals, subcutaneous drugs can be self-administered by patients anywhere, greatly enhancing convenience. The U.S. Food and Drug Administration (FDA) also recognized the convenience of subcutaneous injections and recommended Celltrion apply for approval of the existing biosimilar RemsimaSC as a new drug, leading to its approval as the new drug Jimpendra in October last year.

RemsimaSC, which has obtained marketing approval in 50 countries including Europe and Canada, is already rapidly expanding its market in Europe. According to IQVIA, a pharmaceutical market research firm, RemsimaSC held a 20% market share in the five major European countries (EU5) as of the third quarter of last year. Combined with Remsima, the market share rises to 72%.

Following Europe, the U.S. will also target the market through direct sales marketing centered on its local subsidiary. Considering that infliximab has been used for over 20 years with sufficient verification of efficacy and safety, and the relatively high economic and physical barriers to medical facilities in the U.S. healthcare environment, the plan is to emphasize Jimpendra’s strength of self-administration to the fullest. In particular, by setting a higher sales price compared to biosimilars through new drug approval and filing patents on the subcutaneous injection formulation and administration method, Celltrion aims to secure a stable revenue base with patent protection lasting until 2040.

A Celltrion official said, "With this initial shipment, the supply of Jimpendra to the U.S. market has officially begun," adding, "As expectations from medical professionals and patients for Jimpendra rise, we will finalize various launch marketing activities such as patient support programs to ensure that the therapeutic benefits of Jimpendra reach U.S. patients."

This content was produced with the assistance of AI translation services.