Celltrion gains EC approval for Avtozma, a RoActemra biosimilar for autoimmune diseases

Celltrion has received marketing authorization from the European Commission (EC) for Avtozma, a biosimilar to RoActemra (tocilizumab), expanding the company’s footprint in the immunology and autoimmune treatment sector. This approval allows Avtozma to be prescribed for all indications of its reference product, including moderate to severely active rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis.

The Avtozma approval in Europe is expected to enhance treatment accessibility while addressing the rising demand for cost-effective alternatives to biologics. As healthcare systems across Europe continue to face budget constraints, biosimilars like Avtozma provide an essential solution for improving patient access to life-changing therapies.

How Was Avtozma Approved as a Biosimilar to RoActemra?

The European Commission’s decision was based on a comprehensive clinical trial evaluating biosimilar equivalence between Avtozma and RoActemra. Data from a global Phase III clinical trial demonstrated that Avtozma matched RoActemra in terms of efficacy, pharmacokinetics, safety, and immunogenicity. The study’s primary endpoint measured the mean change from baseline in Disease Activity Score (DAS28-ESR) at Week 12, confirming biosimilar efficacy in treating autoimmune diseases.

Further analysis showed that Avtozma maintained its therapeutic effectiveness up to Week 52, reinforcing its potential as a long-term treatment option for inflammatory conditions. Regulatory experts have emphasized that the biosimilar development for immune diseases is becoming increasingly important as healthcare providers seek sustainable alternatives to costly biologics.

What Are the Key Benefits of Avtozma’s Approval in Europe?

The approval of Avtozma strengthens Celltrion’s biosimilar portfolio, which already includes Remsima (infliximab), Yuflyma (adalimumab), Truxima (rituximab), Herzuma (trastuzumab), and Vegzelma (bevacizumab). With the addition of Avtozma, the company further establishes its presence in the immunology sector, offering biosimilar alternatives for autoimmune diseases that align with European healthcare policies promoting cost-effective biologic therapies.

Avtozma also received U.S. Food and Drug Administration (FDA) approval in January 2025, reflecting its potential to compete in global markets. Industry analysts predict that as more biosimilars gain regulatory approval, they will reshape prescribing patterns for autoimmune diseases, particularly for conditions like rheumatoid arthritis and juvenile idiopathic arthritis.

How Does Avtozma Work in Treating Autoimmune Diseases?

Avtozma contains tocilizumab, a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. IL-6 plays a key role in inflammation and immune system dysregulation, contributing to the progression of rheumatoid arthritis, giant cell arteritis, and juvenile idiopathic arthritis.

By blocking IL-6 receptor activity, Avtozma reduces inflammation and slows disease progression, offering patients an effective treatment option with a comparable safety profile to RoActemra. The biosimilar approval for rheumatoid arthritis and other autoimmune diseases supports the European healthcare system’s goal of increasing treatment accessibility while maintaining therapeutic efficacy.

What Does the Future Hold for Biosimilars in Autoimmune Treatment?

The European Commission’s approval of Avtozma marks a significant step toward broader biosimilar adoption in autoimmune disease management. As biosimilar development continues, more healthcare providers are expected to incorporate these alternatives into routine treatment protocols, leading to cost savings for healthcare systems and improved patient access to biologic treatments.

Industry experts suggest that the biosimilar market for autoimmune diseases will continue to grow, driven by increasing regulatory approvals and strong clinical data supporting efficacy and safety. With the addition of Avtozma, Celltrion reinforces its position as a leader in biosimilar development for immune diseases, offering innovative solutions that address both clinical and economic challenges in immunology treatment.

The Avtozma approval in Europe represents a major milestone in the biosimilar industry, offering a new alternative for treating autoimmune diseases while reinforcing the global push toward cost-effective biologic therapies. As biosimilar alternatives for autoimmune diseases gain traction, Celltrion’s latest approval is expected to reshape the treatment landscape, benefiting both healthcare providers and patients. With regulatory approvals expanding across multiple regions, Avtozma is positioned to challenge originator biologics and drive innovation in biosimilar development for immune diseases.