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Celltrion's autoimmune disease treatment Zymfentra (Celltrion) |
Biopharmaceutical giant Celltrion announced Wednesday that the first batch of its new autoimmune disease treatment Zymfentra, also known as Remsima SC, has been shipped for its planned debut in the US next month.
Zymfentra is the first and only subcutaneous injection version of Remsima, Celltrion’s infliximab biosimilar, to have been approved by the US Food and Drug Agency.
The company said its more patient-friendly administration compared to the current intravenous injection version is expected to address the needs of both patients and health care professionals for more convenient treatment options.
Recognized for its therapeutic effectiveness and convenience, Remsima SC has received authorization in over 50 countries, encompassing Europe and Canada, leveraging its success to penetrate the lucrative US pharmaceutics market. Remsima SC and Remsima together achieved a 72 percent market share in the five major European countries by the third quarter of last year, with Remsima SC alone securing 20 percent, according to IQVIA, a pharmaceutical market research firm.
Tailoring to the US market, Celltrion focuses on its self-injection capability to address health care accessibility challenges. The company has secured patent protection for its SC formulation and administration method until 2040, enabling competitive pricing and revenue stability over biosimilars.
IQVIA reports that Zymfentra's target market for inflammatory bowel disease, focusing solely on TNF-alpha inhibitors, was valued at approximately $9.83 billion in 2022, potentially expanding to $21.8 billion when considering other treatment types.
While the first batch left for Atlanta, the company anticipates that the product will be available for market supply by mid-March -- following the completion of import customs clearance, transportation and wholesaler stocking processes.
"As medical professionals' and patients' expectations for Zymfentra are increasing, we will make all necessary preparations to ensure that the therapeutic benefits of Zymfentra are delivered to patients in the US as well, including final checks on various launch marketing activities, such as patient support programs," a Celltrion official added.
