#United States #Incheon #Celltrion #AVTOZMA #tocilizumab-anoh

Celltrion Unveils AVTOZMA® Subcutaneous Formulation in the U.S.

On March 16, 2026, Celltrion, Inc. announced the commercial availability of AVTOZMA® (tocilizumab-anoh) in a subcutaneous (SC) formulation for patients in the United States. This launch marks a significant advancement in Celltrion's immunology portfolio, expanding its offerings for patients with chronic inflammatory diseases.

AVTOZMA® becomes a noteworthy player in the U.S. market as one of the first tocilizumab biosimilars to gain approval from the Food and Drug Administration (FDA) in both intravenous (IV) and SC formulations. This dual availability enhances treatment options for healthcare providers and patients, facilitating personalized therapy choices based on individual patient needs.

“Introducing AVTOZMA SC represents a major milestone for Celltrion,” said Thomas Nusbickel, Chief Commercial Officer of Celltrion USA. He emphasized their commitment to providing effective and user-friendly treatment options that are accessible to patients suffering from chronic inflammatory conditions. The new SC option aims to not only streamline treatment processes but also enhance patient convenience.

The SC formulation of AVTOZMA is indicated for managing several conditions, including:

• - Rheumatoid Arthritis (RA): For adults who have not adequately responded to other treatments.
• - Giant Cell Arteritis (GCA): Targeting adult patients affected by this disease.
• - Polyarticular Juvenile Idiopathic Arthritis (PJIA) and Systemic Juvenile Idiopathic Arthritis (SJIA): For children aged two and older.

Available in a convenient 162 mg/0.9 mL injectable solution, AVTOZMA SC comes in both a single-dose prefilled syringe and a prefilled autoinjector, allowing patients to self-administer their treatment from the comfort of their homes. This flexibility aims to improve adherence to treatment regimens and promote better health outcomes.

To support patients prescribed AVTOZMA, Celltrion established the Celltrion CONNECT™ patient support program. This initiative offers tailored assistance, including injection training, reimbursement support, and educational resources designed for both patients and healthcare professionals.

Clinical Insights and Efficacy

AVTOZMA® contains the active ingredient tocilizumab, acting as an interleukin 6 (IL-6) receptor antagonist. It has demonstrated efficacy in clinical trials against various inflammatory diseases, enhancing treatment options for patients. The FDA previously approved its IV formulation for additional conditions, including cytokine release syndrome and COVID-19 complications.

Despite the promising attributes of AVTOZMA, safety considerations are paramount. Patients are advised of serious infection risks related to the drug, alongside gastrointestinal complications and potential hepatotoxicity. Monitoring by healthcare professionals for signs of infection is essential during treatment with AVTOZMA.

As a leading biopharmaceutical entity, Celltrion focuses on innovating and providing effective therapeutic solutions globally. With the launch of AVTOZMA SC, they continue to cement their role in the biosimilar sector, responding to patient needs through advanced therapy options.

Conclusion

Celltrion's launch of the AVTOZMA® subcutaneous formulation in the U.S. marks a significant development in the improvement of care for patients with chronic inflammatory conditions. By enhancing their immunology product lineup, Celltrion showcases its ongoing commitment to bettering the lives of patients in need. For more information and to stay updated, visit Celltrion's website.