Celltrion Receives EC Approval for Avtozma ® (CT-P47), a Biosimilar to RoActemra ® (tocilizumab)
Celltrion today announced that the European Commission (EC) has granted marketing authorization for Avtozma® (CT-P47), a biosimilar referencing RoActemra® (tocilizumab). Avtozma® has been approved for all indications of its reference product, including moderate to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and giant cell arteritis (GCA).1 The approval further strengthens Celltrion’s growing immunology portfolio.
“Today’s approval of Avtozma®, a biosimilar to RoActemra®, marks a critical step in Celltrion’s mission to provide European healthcare systems with affordable, effective solutions for immunological disorders. By leveraging our integrated operations, we strengthen the stability of supply chains and enhance collaboration with European healthcare professionals,” said Taehun Ha, Senior Vice President and Head of Europe at Celltrion. “We are committed to delivering value-driven solutions tailored to the unique needs of the European market.”
The EC approval on Avtozma® was supported by a comprehensive data package and totality of evidence, including the results from a phase III study demonstrating biosimilarity between Avtozma® and the reference product. The primary endpoint was met in terms of mean change from baseline in Disease Activity Score (DAS) using 28 joints (DAS28)-ESR at Week 12, and the final results supported comparability in secondary efficacy, pharmacokinetics (PK), safety and immunogenicity results between Avtozma® and RoActemra®.2,3
Avtozma® is Celltrion’s twelfth biosimilar product approved by the EC, following the approval of 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).
About CT-P47 Phase III Clinical Trial2,3
This was a Phase III, randomised, active-controlled, double-blind trial to compare the efficacy and safety of Avtozma® (CT-P47) and RoActemra® (tocilizumab) in patients with moderate to severely active rheumatoid arthritis (RA). Therapeutic equivalence of CT-P47 and reference tocilizumab in treating RA was demonstrated and supported by comparable and sustained efficacy results up to Week 52. CT-P47 was also well tolerated with a safety profile comparable to reference tocilizumab, and no notable safety issue was identified following the single transition from reference tocilizumab to CT-P47 compared with maintenance groups up to Week 52.
About Avtozma® (CT-P47, biosimilar tocilizumab)
Avtozma®, containing the active ingredient tocilizumab, is a recombinant humanised monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Based on data from the global Phase III clinical trial, designed to evaluate the efficacy, pharmacokinetics, safety, and immunogenicity of Avtozma® compared to the reference product2,3, Avtozma® has been approved for all indications of its reference product, including moderate 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. FDA in January 2025.
About Celltrion
Celltrion is a leading biopharmaceutical company that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook.
FORWARD-LOOKING STATEMENT
Certain information set forth in this press release contains statements related to our future business, and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws.
These statements may be identified by words such as “prepares,” “hopes to,” “upcoming,” ”plans to,” “aims to,” “to be launched,” “is preparing,” “once gained,” “could,” “with the aim of,” “may,” “once identified,” “will,” “working towards,” “is due,” “become available,” “has potential to,” the negative of these words or such other variations thereon or comparable terminology.
In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control.
Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.
Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements.
Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws.
Trademarks
Avtozma® is a registered trademark of Celltrion, Inc., used under license.
RoActemra® is a registered trademark of Chugai Pharmaceutical Co., Ltd.
References
_______________________________
1 European Medicines Agency Summary of Product Characteristics (SmPC), Avtozma. [Last accessed February 2025].
2 Smolen JS et al., Efficacy and safety of CT-P47 versus reference tocilizumab: 32-week results of a randomised, active-controlled, double-blind, phase III study in patients with rheumatoid arthritis, including 8 weeks of switching data from reference tocilizumab to CT-P47. RMD Open. 2024;10(4), e004514. Available at: https://rmdopen.bmj.com/content/10/4/e004514.abstract [Last accessed February 2025]
3 Gerd Burmester et al., Similar Efficacy, PK, Safety, and Immunogenicity of Tocilizumab Biosimilar (CT-P47) and Reference Tocilizumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: Week 52 Results from the Phase III Single Transition Study. Poster Presentation (abstract no. 0502). Presented at ACR 2024. Available at: https://acrabstracts.org/abstract/similar-efficacy-pk-safety-and-immunogenicity-of-tocilizumab-biosimilar-ct-p47-and-reference-tocilizumab-in-patients-with-moderate-to-severe-active-rheumatoid-arthritis-week-52-results-from-the/ [Last accessed February 2025]
View source version on businesswire.com: https://www.businesswire.com/news/home/20250221887782/en/
Contacts
Donna Gandhi
dgandhi@hanovercomms.com
+44 (0) 7827 053 502
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
www.businesswire.com
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Kaneka Obtains Halal Certificate for KANEKA UBIQUINOL TM9.7.2025 04:30:00 EEST | Press release
Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Kazuhiko Fujii) (TOKYO:4118) has obtained “Halal Certificate (Certification Number: 355-TSRI/24)” for its functional food ingredient, KANEKA UBIQUINOLTM (active form of coenzyme Q10) powder, under the assessment of Shariah Research Institute of Takushoku University, and issued by JAPAN MUSLIM ASSOCIATION, a religious corporation, on May 28. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250708279133/en/ Halal certificate Halal certification is a system in which relevant organizations verify that products or services do not contain ingredients prohibited under Shariah (Islamic law) and certify their compliance with Shariah. We actively pursue the acquisition of various certifications to ensure the safety and security of our raw materials, and we are pleased to announce that we have obtained a Halal Certificate for KANEKA UBIQUINOLTM. Currently, the Muslim populati
SiPearl: Final closing of €130m Series A with Cathay Venture (Taiwan), EIC Fund and France 20308.7.2025 18:25:00 EEST | Press release
SiPearl, the company building European high-performance energy-efficient processors for supercomputing and AI has achieved the definitive closing of its €130m Series A with a third tranche of €32m. Seed funded by the European Union, SiPearl was launched in January 2020 under the auspices of the European Processor Initiative consortium which aims to foster the return of high-performance energy-efficient processor technologies in Europe. Since then, the company has fulfilled its mission by building a world-class processor team of 200 employees in France, Spain, and Italy, set up its own sovereign infrastructure with data centres in France equipped with servers and emulators dedicated to semiconductor design. SiPearl has completed the conception of the most complex processor ever designed in Europe, Rhea1. With 80 Arm Neoverse V1 cores, Rhea1 is composed of more than 61bn transistors. Several weeks ago, Rhea1 taped-out and was handed off to the world’s leading foundry, TSMC in Taïwan, for
LambdaTest Unveils Smart Branching and Baseline Management to Modernize Visual Testing Workflows8.7.2025 18:00:00 EEST | Press release
LambdaTest, a GenAI-powered quality engineering platform, has announced the release of SmartUI’sSmart Branching and Baseline Management, a major leap forward in visual testing. This update eliminates long-standing bottlenecks caused by outdated baseline strategies and introduces an intelligent, streamlined way for development teams to manage visual testing across complex Git workflows. Modern development teams utilise feature branches, release versions, and hotfix workflows; however, most visual testing tools still rely on comparisons against the main branch, resulting in irrelevant failures and time-consuming approvals. LambdaTest’s SmartUI changes that with features purpose-built for today’s branching strategies. Smart Branch Comparison ensures visual tests are run against the correct baseline, comparing within the same feature branch instead of defaulting to the main. Flexible Merging Options automatically create and approve merged visual states, eliminating the need for manual appr
Connectivity as Versatile as the Aircraft, Starlink High-Speed Internet Now Available for Cessna Caravan8.7.2025 17:00:00 EEST | Press release
Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced an additional high-speed internet connectivity solution for the Cessna Citation Caravan following the Federal Aviation Administration’s (FAA) issuance of AeroMech’s Supplemental Type Certificate (STC) for Starlink high-speed internet connectivity. AeroMech’s STC utilizes Starlink’s constellation of Low Earth Orbit (LEO) satellites to provide more reliable connectivity over land, water and remote areas, where traditional in-flight Wi-Fi may not have service. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250708514119/en/ Textron Aviation announced an additional high-speed internet connectivity solution for the Cessna Citation Caravan following the Federal Aviation Administration’s (FAA) issuance of AeroMech’s Supplemental Type Certificate (STC) for Starlink high-speed internet connectivity. (Photo: Textron Aviation) “The Cessna Caravan is so versatile,
Rigaku Announces STAvesta, a Thermal Analyzer Tailor-made for Next-generation Material Development8.7.2025 17:00:00 EEST | Press release
Rigaku Corporation, a Group company of Rigaku Holdings Corporation (headquarters: Akishima, Tokyo; CEO: Jun Kawakami; hereinafter “Rigaku”) has launched worldwide sales of STAvesta, a thermal analyzer that simultaneously measures a sample’s weight and change in calorific value during heating. STAvesta responds to needs in a wide array of fields where thermal analysis is required. It is expected to find use in a wide variety of material-analysis applications for the development of advanced features and complex materials. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250708207135/en/ STAvesta FlatBlank, a Revolutionary Auto-adjustment Feature, Dramatically Reduces Workload In conventional thermal analysis, baseline adjustment must be performed by hand before measurement can begin. This process can be time-consuming and frustrating, particularly for novice users. Rigaku’s newly developed FlatBlank, a baseline auto-adjustment f
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom