Celltrion's AVTOZMA®: A New Era for IV Treatments in the US Market

Introduction

On October 2, 2025, Celltrion, a pivotal player in the biopharmaceutical landscape, announced the launch of its intravenous (IV) formulation of AVTOZMA® (tocilizumab-anoh) in the United States. This development reflects a significant leap in immunotherapy options and aims to provide comprehensive treatment alternatives for numerous immune-mediated diseases.

FDA Approval

In January 2025, the U.S. Food and Drug Administration (FDA) granted approval for AVTOZMA®, allowing it to treat the same conditions as its reference product, Actemra® (tocilizumab). This includes autoimmune disorders such as rheumatoid arthritis (RA) and giant cell arteritis (GCA), alongside severe health complications like COVID-19 and cytokine release syndrome (CRS). The approval signifies Celltrion’s ongoing commitment to enhancing patient healthcare by providing additional, high-quality treatment options.

A Comprehensive Immunology Portfolio

With the introduction of AVTOZMA®, Celltrion deepens its immunology portfolio, expanding from tumor-necrosis factor (TNF)-alpha and interleukin (IL)-12 and IL-23 inhibitors to now include an IL-6 inhibitor. This broadening of therapeutic mechanisms is crucial as it ensures that a broader spectrum of diseases and patient needs can be addressed. This initiative highlights Celltrion’s strategic ambition of not just being a contributor in the biosimilar segment but rather a leader striving for innovation and better health outcomes.

Clinical Impact

Healthcare professionals have hailed the addition of AVTOZMA® to available biosimilars. Prof. Gerd-Rüdiger Burmester, a distinguished figure in rheumatology from Berlin, acknowledged that immune-mediated conditions could severely affect patients' quality of life. He stated that the availability of this tocilizumab biosimilar offers physicians essential flexibility in treating patients, ensuring they can manage their conditions effectively, which is of paramount importance for sustaining continuity of care and improving patient satisfaction.

Product Formats

AVTOZMA® IV will be made available in three formulations: 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL, all designed for single-dose use. The usage of established configurations was a deliberate choice by Celltrion to maintain a seamless transition for healthcare providers familiar with Actemra®. This ensures that existing treatment protocols can be adapted without requiring major overhauls, facilitating easier clinical adoption.

Supporting Resources

In conjunction with the product launch, Celltrion is rolling out a plethora of patient support resources aimed at both healthcare providers and patients to enhance treatment experiences. Importantly, there will be a co-pay support program for eligible commercial patients prescribed AVTOZMA®, reflecting Celltrion’s commitment to reducing financial barriers and ensuring equitable access to treatment.

Addressing Safety Concerns

While the introduction of AVTOZMA® represents a significant advancement in immunotherapy, it is essential to note the safety warnings associated with its use. The product may heighten the risk of serious infections and other side effects such as gastroenteritis and hepatotoxicity. Patients will need careful monitoring, especially those with a history of serious infections or other underlying health conditions. As a part of this initiative, Celltrion maintains a focus on educating healthcare providers about these risks to promote safer prescribing practices and patient education.

Conclusion

The launch of AVTOZMA® marks a significant milestone for Celltrion and sets a new standard for intravenous treatments in the U.S. market. By diversifying its immunology portfolio and enhancing accessibility through supportive measures, Celltrion reinforces its position as a leader in pharmaceutical innovation, dedicated to improving patient care and outcomes in a challenging healthcare environment. As healthcare continues to evolve, Celltrion’s commitment to advancing science stands as a promising testament to the future of immunotherapy.