Aflibercept biosimilar(Celltrion)

Avtozma® (CT-P47), a biosimilar referencing RoActemra® (tocilizumab) is approved by the European Commission (EC) for all indications of the reference product1 EC approval is based on a comprehensive data package demonstrating Avtozma®’s biosimilarity to RoActemra®2,3 Celltrion’s biosimilar portfolio continues to grow, expanding treatment options to meet the needs of people with immune diseases Avtozma® (CT-P47), a biosimilar referencing RoActemra® (tocilizumab) is approved by the European Commission (EC) for all indications of the reference product1 EC approval is based on a comprehensive data package demonstrating Avtozma®’s biosimilarity to RoActemra®2,3 Celltrion’s biosimilar portfolio continues to grow, expanding treatment options to meet the needs of people with immune diseases February 23, 2025 06:50 PM Eastern Standard Time INCHEON, South Korea--(BUSINESS WIRE)--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]

Avtozma ® (CT-P47), a biosimilar referencing RoActemra ® (tocilizumab) is approved by the European Commission (EC) for all indications of the reference product 1 EC approval is based on a comprehensive data package demonstrating Avtozma ® ’s biosimilarity to RoActemra ®2,3 Celltrion’s biosimilar portfolio continues to grow, expanding treatment options to meet the needs of people with immune diseases INCHEON, South Korea--(BUSINESS WIRE)--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]