Celltrion’s Avtozma® (CT-P47) Biosimilar Receives European Commission Approval
Celltrion has announced that the European Commission (EC) has granted marketing authorization for Avtozma® (CT-P47), a biosimilar to RoActemra® (tocilizumab). Avtozma® is approved for all indications of its reference product, RoActemra®, including moderately to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and giant cell arteritis (GCA). This approval marks an important milestone for Celltrion, expanding its immunology product portfolio and enhancing the availability of treatment options for patients with immune diseases across Europe.
A Step Forward in Providing Cost-Effective Immune Disease Solutions
Taehun Ha, Celltrion’s Senior Vice President and Head of Europe, commented on the approval, stating, “Today’s approval of Avtozma®, the biosimilar to RoActemra®, represents a critical step forward in Celltrion’s mission to provide cost-effective immune disease solutions to the European healthcare system. By leveraging our integrated operations, we have enhanced supply chain stability and partnerships with European healthcare professionals. We are committed to delivering value-driven solutions tailored to the unique needs of the European market.”
The approval of Avtozma® is part of Celltrion’s ongoing effort to address the growing demand for affordable treatment options for patients with various autoimmune conditions. As healthcare systems across Europe continue to prioritize cost-effective treatments, biosimilars like Avtozma® offer a significant opportunity to improve patient access to critical therapies.
Robust Evidence Supporting Biosimilarity to RoActemra®
The European Commission’s approval of Avtozma® is based on comprehensive clinical data, including results from a Phase III study that demonstrated the biosimilarity of Avtozma® to RoActemra®. The primary endpoint of the study was the mean change from baseline in the Disease Activity Score in 28 joints (DAS28)-erythrocyte sedimentation rate (ESR). The study successfully met this primary endpoint at week 12, showing that Avtozma® performed comparably to RoActemra® in terms of efficacy.
In addition to the primary endpoint, the study also evaluated secondary outcomes, including pharmacokinetic (PK), safety, and immunogenicity data. The results supported the biosimilarity of Avtozma® and RoActemra®, further reinforcing the safety and efficacy profile of the new biosimilar. These robust findings provide confidence in the ability of Avtozma® to deliver the same high-quality treatment as the reference product.
Expanding Celltrion’s Biosimilar Portfolio
Avtozma® is the 12th biosimilar product approved by the European Commission for Celltrion, further expanding the company’s portfolio of high-quality, cost-effective therapies. Celltrion’s portfolio includes a range of biosimilars for various therapeutic areas, such as oncology, immunology, and other chronic diseases. Some of the previously approved biosimilars from Celltrion include:
- Remsima® (intravenous infliximab)
- Remsima® SC (subcutaneous infliximab)
- Yuflyma® (adalimumab)
- SteQeyma® (ustekinumab)
- Truxima® (rituximab)
- Herzuma® (trastuzumab)
- Vegzelma® (bevacizumab)
- Omlyclo® (omalizumab)
- Eydenzelt® (aflibercept)
- Stoboclo® and Osenvelt® (denosumab)
The approval of Avtozma® strengthens Celltrion’s position as a leader in the global biosimilar market. With its extensive portfolio of biosimilars, the company is committed to making essential treatments more affordable and accessible to patients worldwide, helping to reduce the burden of expensive biologic therapies on healthcare systems.
Addressing the Need for Biosimilars in Immune Disease Treatment
Avtozma®’s approval comes at a time when the demand for biologic treatments for autoimmune diseases is rising. Diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, and giant cell arteritis require long-term management with medications that are often costly. Biosimilars like Avtozma® provide a more affordable alternative to reference biologics, offering patients access to critical therapies while helping to reduce healthcare costs.
Rheumatoid arthritis, systemic juvenile idiopathic arthritis, and other autoimmune diseases can cause significant long-term damage to joints and organs if not properly treated. Avtozma® will play an important role in managing these conditions, offering a cost-effective option for patients and healthcare providers in Europe. With its demonstrated biosimilarity to RoActemra®, Avtozma® is expected to become an essential part of the treatment landscape for these diseases.
The Future of Celltrion’s Immunology Portfolio
Looking forward, Celltrion plans to continue expanding its biosimilar portfolio to meet the evolving needs of patients with immune diseases. The approval of Avtozma® is just one example of the company’s ongoing efforts to improve patient access to essential biologic treatments. By focusing on the development of high-quality biosimilars, Celltrion is helping to make life-saving therapies more accessible and affordable for patients worldwide.
The company’s success in securing regulatory approvals for its biosimilars in Europe and other global markets further solidifies its position as a leader in the biosimilar space. As healthcare systems continue to seek ways to manage rising drug costs, the role of biosimilars in improving access to treatment will only continue to grow. Celltrion remains committed to advancing its biosimilar portfolio and contributing to better healthcare outcomes for patients with immune diseases.
Conclusion
The European Commission’s approval of Avtozma® (CT-P47) represents a significant achievement for Celltrion and a crucial step forward in providing cost-effective treatment options for patients with immune diseases. As part of the company’s expanding biosimilar portfolio, Avtozma® offers a reliable and affordable alternative to RoActemra® for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, and giant cell arteritis. With its robust clinical evidence supporting biosimilarity, Avtozma® is poised to make a meaningful impact in the European healthcare market, furthering Celltrion’s mission to improve patient access to high-quality, life-changing therapies.
About the CT-P47 Phase III Clinical Trial2,3
This is a Phase III randomized, active-controlled, double-blind trial designed to compare the efficacy and safety of Avtozma ® (CT-P47) and RoActemra ® (tocilizumab) in patients with moderately to severely active rheumatoid arthritis (RA). Therapeutic equivalence of CT-P47 to the reference drug tocilizumab in the treatment of RA was demonstrated and supported by comparable and sustained efficacy results through Week 52. CT-P47 was also well tolerated, and its safety profile was comparable to that of the reference drug tocilizumab. After switching from the reference drug tocilizumab to CT-P47 alone, no significant safety issues were found until week 52 compared with the maintenance group.
About Avtozma ® (CT-P47, biologic tocilizumab)
Avtozma ® is a reshaped humanized monoclonal antibody with tocilizumab as the active ingredient, which can be used as an interleukin-6 (IL-6) receptor antagonist. Based on data from a global Phase III clinical trial designed to evaluate the efficacy, pharmacokinetics, safety and immunogenicity of Avtozma® compared to a reference product2,3 , Avtozma® has been approved for all indications of its reference product, including moderately to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and giant cell arteritis (GCA) 1 . Avtozma® was also approved by the U.S. Food and Drug Administration (FDA) in January 2025.
About Celltrion
Celltrion is a leading biopharmaceutical company engaged in the research, development, manufacturing, marketing and sale of innovative therapeutics to improve the lives of people worldwide. Celltrion is a pioneer in the field of biologic drugs and has launched the world’s first monoclonal antibody biologic drug. Our global portfolio of medicines spans multiple therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. In addition to biological drug products, we are committed to advancing the research and development product line of new drugs, breaking the boundaries of scientific innovation and providing high-quality medicines. For more information, visit our website: www.celltrion.com/en-us and follow us on our social media ( LinkedIn , Instagram , X and Facebook ) for the latest news and events.
