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Celltrion Commences Shipment of Remsima SC for U.S. Debut

Credits: EY

Biopharmaceutical company Celltrion has announced the shipment of the first batch of its new autoimmune disease treatment, Zymfentra (Remsima SC), for its planned launch in the United States next month

. Zymfentra is the subcutaneous injection version of Remsima, Celltrion’s biosimilar to infliximab, and it is the first and only such version approved by the US Food and Drug Administration (FDA).

The company highlights Zymfentra’s more patient-friendly administration compared to the current intravenous injection version of Remsima, which is expected to meet the needs of patients and healthcare professionals for more convenient treatment options.

Celltrion (Credits: DVNET)

Remsima SC has been authorized in over 50 countries, including Europe and Canada, and has achieved significant market share in Europe, with Remsima SC alone securing 20 percent, according to IQVIA.

Celltrion is focusing on the self-injection capability of Zymfentra to address healthcare accessibility challenges in the US market. The company has secured patent protection for its subcutaneous formulation and administration method until 2040, which enables competitive pricing and revenue stability over biosimilars.

IQVIA reports that Zymfentra’s target market for inflammatory bowel disease, focusing on TNF-alpha inhibitors, was valued at approximately $9.83 billion in 2022 and could expand to $21.8 billion when considering other treatment types.

The first batch of Zymfentra has been shipped to Atlanta, and the company expects the product to be available for market supply by mid-March, following completion of import customs clearance, transportation, and wholesaler stocking processes.

Celltrion is preparing for the launch of Zymfentra in the US by conducting final checks on various launch marketing activities, including patient support programs, to ensure that the therapeutic benefits of Zymfentra are delivered to patients.

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