Avtozma (tocilizumab-anoh) / Celltrion - LARVOL DELTA

Celltrion added that its newly approved rheumatoid arthritis drug Avtozma (tocilizumab), cleared by Japan’s Ministry of Health, Labour and Welfare last month, is scheduled for launch next year (Pulse by Maeil Business News Korea)

Launch Japan • Rheumatoid Arthritis

Celltrion's Avtozma Launches in the US...Insurance Companies' Formularies Listed [Google translation] - "According to the company, Avtozma was launched in the US at a high wholesale price (WAC), approximately 35% lower than the original drug....With Minnesota's listing progressing rapidly, the likelihood of Avtozma being adopted as a preferred drug in other BCBS states is expected to increase significantly. The company anticipates that Avtozma's listing will accelerate further, as negotiations are ongoing with major players, including BCBS and the three largest prescription drug benefit managers (PBMs) in the United States. "

Cytokine release syndrome • US reimbursement • Giant Cell Arteritis • Idiopathic Arthritis • Rheumatoid Arthritis

Celltrion launches AVTOZMA (tocilizumab-anoh) intravenous (IV) formulation in the United States (PRNewswire) - "AVTOZMA IV is approved for all same indications as the reference product Actemra (tocilizumab), including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (PJIA), systemic juvenile idiopathic arthritis (SJIA), coronavirus disease (COVID-19) and cytokine release syndrome (CRS)....The available presentations are 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), 400 mg/20 mL (20 mg/mL) in single-dose vials."

Biosimilar launch • Cytokine release syndrome • Giant Cell Arteritis • Idiopathic Arthritis • Rheumatoid Arthritis

CT-P47/Tocilizumab-anoh: A Tocilizumab Biosimilar. (PubMed, Clin Drug Investig) - "The overall safety and immunogenicity profiles of CT-P47 were similar to those of reference tocilizumab, and switching from reference tocilizumab to CT-P47 did not affect safety or efficacy. The role of reference tocilizumab in the management of inflammatory diseases is well established and CT-P47 provides an effective biosimilar alternative for patients requiring tocilizumab therapy."

Journal • Review • Giant Cell Arteritis • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Novel Coronavirus Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology

Celltrion wins Japan approval for biosimilar AVTOZMA targeting autoimmune market (Chosun Biz) - "AVTOZMA secured approvals for the main indications (target disease groups) held by the original drug, including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Castleman disease (CD), and cytokine release syndrome (CRS). Celltrion plans to expedite the launch of AVTOZMA in Japan as a first-mover biosimilar and move quickly to expand its market share."

Cytokine release syndrome • Japan approval • Idiopathic Arthritis • Rheumatoid Arthritis

Celltrion, 'Avtozma' Phase 3 52-week results published in international academic journal [Google translation] (HIT News) - P3 | N=471 | NCT05489224 | Sponsor: Celltrion | "According to the company, this study contains the long-term results of a phase 3 clinical trial that evaluated the efficacy, pharmacokinetics, safety, and immunogenicity of the intravenous formulation of CT-P47 in 471 patients with rheumatoid arthritis....As a result, the main evaluation indicators showed similar levels in all three groups. The company explained that efficacy, safety, pharmacokinetics, and immunogenicity were maintained not only in the group that continued to administer CT-P47 but also in the replacement administration group that switched from the original drug to CT-P47."

P3 data • Rheumatoid Arthritis

Efficacy and Safety of Biosimilar CT-P47 Versus Reference Tocilizumab: 1-Year Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study in Patients with Rheumatoid Arthritis. (PubMed, Clin Drug Investig) - P3 | "Week 52 results show maintained efficacy after switching from r-TCZ to CT-P47, and comparable efficacy, pharmacokinetics, safety and immunogenicity of CT-P47 versus r-TCZ over 1 year of treatment."

Journal • P3 data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

FDA approves expanded indication for AVTOZMA (tocilizumab-anoh) intravenous (IV) formulation in cytokine release syndrome (CRS) (PRNewswire) - "Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication of the intravenous (IV) formulation of AVTOZMA (tocilizumab-anoh) to include the treatment of cytokine release syndrome (CRS) in adults and pediatric patients aged 2 years and older. Following FDA approval of the additional indication for CRS, AVTOZMA IV now aligns with all indications approved for ACTEMRA IV in the United States....In accordance with the patent settlement agreement with Genentech, the IV formulation of AVTOZMA is expected to be available in the U.S. on August 31, 2025."

Biosimilar launch • Cytokine release syndrome • FDA approval • Immunology

Binex inks new Celltrion deal to make clinical-stage biosimilars (Korea Biomedical Review) - "Korea-based CDMO Binex has secured a fresh manufacturing deal with Celltrion to produce drug substances for two clinical-stage biosimilar candidates, the company said Monday. Under the contract, Binex will receive Celltrion’s process technology to manufacture the unnamed biologics at its facilities in Songdo and Osong. Financial details and product names were not disclosed due to confidentiality terms....That collaboration led to the commercial launch of Avtozma, Celltrion’s Actemra (tocilizumab) biosimilar used to treat autoimmune diseases, which Binex now produces at scale for global distribution."

Licensing / partnership • Giant Cell Arteritis • Idiopathic Arthritis • Rheumatoid Arthritis

EXPLORING THE BUDGETARY IMPACT OF TOCILIZUMAB BIOSIMILAR IN FRANCE: A FIVE-YEAR ANALYSIS (EULAR 2025) - "This five-year budget analysis highlights the significant cost savings achievable by introducing a tocilizumab biosimilar priced 30% lower than its originator, into the French healthcare system. These savings, exceeding €64 million, coincide with increased patient access to biologic therapies—over 12,500 additional patients treated by 2029. These findings provide valuable guidance for policymakers, payers, and stakeholders in shaping cost-effective healthcare strategies."

Giant Cell Arteritis • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Novel Coronavirus Disease • Rheumatoid Arthritis • Rheumatology

Celltrion Pharm launches biosimilar Avtozma for autoimmune diseases in South Korea (Chosun Biz) - "Celltrion Pharm announced on the 2nd that it will begin domestic sales of 'Avtozma' (a biosimilar of ACTEMRA, ingredient name tocilizumab), a treatment for autoimmune diseases. ACTEMRA, developed by Swiss Roche, is an interleukin inhibitor that reduces inflammation by inhibiting interleukin (IL)-6 protein involved in causing inflammation. Rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and polyarticular juvenile idiopathic arthritis (pJIA) are the main diseases treated....To secure a competitive edge with the launch of this SC formulation, Celltrion Pharm plans to hold information sessions for medical personnel. It also plans to release the intravenous (IV) formulations of Avtozma (80 mg, 200 mg, 400 mg) within the year."

Biosimilar launch • Idiopathic Arthritis • Rheumatoid Arthritis

AbbVie…UCB collect Korea nods for June reimbursement lineup (Korea Biomedical Review) - "Korea’s national health insurance program is expanding coverage across autoimmune diseases...and inflammation...set to take effect June 1...The update adds UCB’s Bimzelx...AbbVie’s Rinvoq, and Celltrion’s biosimilar to Roche’s Actemra to the reimbursement list...Bimzelx: Korea's first IL-17A/F inhibitor enters psoriasis coverage...Coverage is priced at 801,332 won ($583.13) and continues only if patients show at least a 75 percent PASI reduction after 16 weeks, with biannual reassessments required to maintain access...Rinvoq: Psoriatic arthritis joins Korea's coverage list...Avtozma: Celltrion's Actemra biosimilar hits market at 30% discount....Rounding out the update is Celltrion’s Avtozma, a subcutaneous (SC) biosimilar to Roche’s tocilizumab used for autoimmune diseases, reimbursed at 245,938 won ($178.76), approximately 30 percent lower than the price of branded Actemra."

Reimbursement • Immunology • Psoriasis • Psoriatic Arthritis

Celltrion Receives EC Approval for Avtozma (CT-P47), a Biosimilar to RoActemra (tocilizumab) (Businesswire) - "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)....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."

EMA approval • Giant Cell Arteritis • Idiopathic Arthritis • Rheumatoid Arthritis

Celltrion secures approval for Actemra biosimilar SC form in Korea (Korea Biomedical Review) - "Celltrion said it obtained product approval from the Ministry of Food and Drug Safety (MFDS) for the subcutaneous (SC) formulation of Avtozma, a biosimilar referencing Actemra (ingredient: tocilizumab), for the treatment of autoimmune diseases....The Korean regulator approved the SC form based on the results of a global phase 3 clinical trial."

Korea approval • Immunology

U.S. FDA approves Celltrion's AVTOZMA (tocilizumab-anoh), a biosimilar to ACTEMRA (PRNewswire) - "Celltrion...announced that the U.S. Food and Drug Administration (FDA) has approved AVTOZMA (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to ACTEMRA. AVTOZMA is indicated for the treatment of multiple diseases including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and coronavirus disease (COVID-19)....The FDA's decision is based on a comprehensive data package and the totality of evidence, including the results from a phase III study demonstrating biosimilarity between AVTOZMA and reference tocilizumab in patients with moderate to severe active RA....The clinical results demonstrated that AVTOZMA and its reference tocilizumab are highly similar and have no clinically meaningful differences in terms of efficacy, safety, pharmacokinetics (PK) and immunogenicity."

FDA approval • Giant Cell Arteritis • Idiopathic Arthritis • Novel Coronavirus Disease • Rheumatoid Arthritis

Usability, efficacy, and safety of candidate tocilizumab biosimilar CT-P47 self-administration via auto-injector and pre-filled syringe in patients with rheumatoid arthritis: a single-arm, open-label, phase 3 study. (PubMed, Expert Rev Clin Immunol) - P3 | "CT-P47 self-administered using an AI showed successful usability in patients with moderate-to-severe RA. ClinicalTrials.gov identifier: NCT05725434."

Journal • P3 data • Hematological Disorders • Immunology • Inflammatory Arthritis • Leukopenia • Neutropenia • Rheumatoid Arthritis • Rheumatology

Celltrion’s Actemra biosimilar wins approval in Korea (Korea Biomedical Review) - "Celltrion said Monday that its biosimilar for Roche's autoimmune disease treatment Actemra (tocilizumab), branded as Avtozma (development code: CT-P47), has received approval from the Ministry of Food and Drug Safety in Korea. Celltrion said Monday that its biosimilar for Roche's autoimmune disease treatment Actemra (tocilizumab), branded as Avtozma (development code: CT-P47), has received approval from the Ministry of Food and Drug Safety in Korea."

Korea approval • Idiopathic Arthritis • Immunology • Rheumatoid Arthritis

Celltrion Receives Positive CHMP Opinion for Three Biosimilars in the European Union (Businesswire) - "Celltrion today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions and recommended marketing authorisations for...biosimilar candidate...Avtozma (CT-P47, tocilizumab)....Avtozma, a biosimilar referencing RoActemra (tocilizumab), has been recommended for all indications of its reference product, including moderate to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), juvenile idiopathic polyarthritis (pJIA) and giant cell arteritis (GCA). The positive CHMP opinion for Avtozma was supported by a comprehensive data package and totality of evidence demonstrating Avtozma’s biosimilarity to RoActemra, with no clinically meaningful differences in efficacy, PK equivalence, safety or immunogenicity."

CHMP • Giant Cell Arteritis • Idiopathic Arthritis • Rheumatoid Arthritis

Celltrion presents phase III data supporting biosimilarity of...CT-P47 at ACR Convergence 2024 (MedigateNews) - P3 | N=471 | NCT05489224 | Sponsor: Celltrion | "...Celltrion presented additional data...for CT-P47, a biosimilar candidate referencing ACTEMRA (tocilizumab) in patients with moderate-to-severe active rheumatoid arthritis (RA) at the American College of Rheumatology (ACR) Convergence 2024 in Washington, D.C....Results of the single transition from the reference tocilizumab to CT-P47 from a Phase III RCT were also presented at the ACR. The 1-year results showed that CT-P47 had comparable and sustained efficacy, safety and immunogenicity profiles in patients with active moderate-to-severe rheumatoid arthritis (RA) compared to the reference tocilizumab even after switching. These data further support biosimilarity of CT-P47."

P3 data • Immunology • Rheumatoid Arthritis

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 (ACR Convergence 2024) - "The study showed that CT-P47 was well tolerated over 1 year in patients with RA, with comparable efficacy, PK, safety, and immunogenicity to those of ref-tocilizumab. In addition, the efficacy has been sustained after switching from ref-tocilizumab to CT-P47 and no notable safety issue was identified following single transition."

Clinical • P3 data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Celltrion's biosimilar CT-P47 demonstrates equivalence to Actemra in P3 study (Korea Biomedical Review) - P3 | N=471 | NCT05489224 | Sponsor: Celltrion | "Celltrion said the phase 3 clinical trial results CT-P47, a biosimilar referencing Roche’s Actemra (ingredient: tocilizumab), have been published in Rheumatic & Musculoskeletal Disease (RMD Open)....The results showed no significant difference between CT-P47 and Actemra, confirming that CT-P47 met the predefined equivalence criteria for efficacy, pharmacokinetics, and safety compared to the reference drug. At the 24-week mark, patients in the Actemra group were randomly assigned to either continue Actemra or switch to CT-P47 in a 1:1 ratio. Between weeks 24 and 32, efficacy, pharmacokinetics, safety, and immunogenicity were evaluated across three groups: patients who continued Actemra, those who switched to CT-P47, and those who had been receiving CT-P47 since the beginning."

P3 data • Immunology • Rheumatoid Arthritis

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. (PubMed, RMD Open) - "Efficacy equivalence, alongside comparable PK, safety and immunogenicity profiles, was determined between CT-P47 and r-TCZ in adults with RA, including after switching from r-TCZ to CT-P47."

Clinical • Journal • P3 data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P3 | N=471 | Completed | Sponsor: Celltrion | Not yet recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Pharmacokinetics and Safety of Intravenous Candidate Biosimilar CT-P47 and Reference Tocilizumab: A Randomized, Double-Blind, Phase 1 Study. (PubMed, J Clin Pharmacol) - "At the end of study, four (8.9%), one (2.3%), and two (4.5%) participants in the CT-P47, EU-tocilizumab, and US-tocilizumab groups, respectively, were ADA-positive; two (4.4%), zero (0%), and one (2.3%) in the respective groups were NAb-positive. CT-P47 demonstrated PK equivalence and comparable safety to EU- and US-tocilizumab."

Clinical • Journal • P1 data • PK/PD data

Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 administered by auto-injector or pre-filled syringe: a randomized, open‑label, single-dose phase I study. (PubMed, Expert Opin Biol Ther) - P1 | "PK equivalence between CT-P47 AI and CT-P47 PFS was demonstrated in healthy Asian adults, with comparable immunogenicity and safety between the two devices. ClinicalTrials.gov: NCT05617183."

Journal • P1 data • PK/PD data