Tyenne (tocilizumab-aazg) / Fresenius Kabi - LARVOL DELTA

Comparable Efficacy of FK-Tocilizumab and Reference Tocilizumab in Rheumatoid Arthritis Patients With and Without Prior Biologic Exposure (ACR Convergence 2025) - "Subgroup analyses by prior biologic exposure support the therapeutic equivalence of FK-tocilizumab and the originator, with no clinically meaningful differences in efficacy. These findings reinforce the reliability of FK-tocilizumab across a range of patient profiles, including those with previous biologic treatment, and underscore its potential to expand access to effective RA therapy."

Clinical • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Switching From Reference Tocilizumab to Biosimilar in Giant Cell Arteritis: Effectiveness and Safety in a Multicenter Study of 38 Patients (ACR Convergence 2025) - "We assessed a) effectiveness including clinical and laboratory parameters, and EULAR definition of remission (absence of signs and symptoms and normalization of acute phase reactants) (5), b) dose of prednisone, and c) side effects...Tyenne was prescribed in monotherapy in 34 (89.5%) patients, and combined with methotrexate in 4 (10.5%) patients... Our results suggest that TCZ-biosimilar is an effective and safe treatment for GCA patients when they were switched from the TCZ-reference product."

Clinical • Giant Cell Arteritis • Herpes Zoster • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • Varicella Zoster

Use of (MSB11456), the first tocilizumab biosimilar approved for rheumatoid arthritis: 6-month data from an international observational study (ACR Convergence 2025) - "The RUBY study evaluates the real-world use of the first tocilizumab biosimilar to treat RA. Results at 6-months demonstrate high persistence on treatment with improvement in RA disease activity and no worsening of cardiovascular comorbidities. Further study will examine factors influencing treatment persistence at 12 months in clinical practice."

Clinical • Observational data • Cardiovascular • Hypertension • Immunology • Inflammation • Inflammatory Arthritis • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology

Economic Value of Tocilizumab Prophylaxis to Prevent Cytokine Release Syndrome (CRS) During Outpatient Teclistamab (Tec) or Talquetamab (Tal) Initiation for Relapsed/refractory Multiple Myeloma (RRMM) (IMS 2025) - "The present study assessed the economic impact of adopting prophylactic tocilizumab to support outpatient administration of Tec or Tal, from a United States healthcare institution perspective. An economic model was developed to calculate costs for Tec and Tal during the SUD period under two alternative approaches for SUD administration: (1) outpatient administration with prophylactic tocilizumab (ACTEMRA®) before the first SUD (additionally, for Tal, prophylactic dexamethasone after each SUD); or (2) inpatient administration (with tocilizumab only as reactive treatment of Gr 2+ CRS, including recurrent Gr 2+ CRS)...A sensitivity analysis was conducted using the price of tocilizumab-aazg (TYENNE®), a biosimilar tocilizumab. Total per-patient costs under the outpatient versus inpatient approaches were estimated to be, respectively, $18,797 vs. $27,639 (difference: -$8,841) for Tec, $18,419 vs, $26,964 (difference: -$8,545) for Tal QW, and $40,767 vs, $53,388..."

Clinical • Cytokine release syndrome • Hematological Malignancies • Inflammation • Multiple Myeloma

RUBY: Real World Use of Tocilizumab Biosimilar studY (clinicaltrials.gov) - P=N/A | N=600 | Active, not recruiting | Sponsor: Fresenius Kabi SwissBioSim GmbH | Recruiting ➔ Active, not recruiting | Trial primary completion date: Feb 2025 ➔ Mar 2026

Enrollment closed • Real-world evidence • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Use of FK-tocilizumab biosimilar (MSB11456) in rheumatoid arthritis patients: 6 months data of the international real-world study RUBY (EULAR 2025) - "RUBY is a non-interventional study designed to evaluate the real-world use of the first tocilizumab biosimilar in RA patients in Europe. Intermediate results show high persistency at 6-months with improved response rates. Identification of factors influencing treatment persistence at 12 months in either switched or newly initiated patients will support doctors in the use of tocilizumab biosimilars in the routine management of RA patients."

Clinical • Real-world • Real-world evidence • Cardiovascular • Hypertension • Immunology • Inflammatory Arthritis • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology

Fresenius Kabi to announce the commercial launch of Tyenne, the first and only approved tocilizumab biosimilar in Canada (Canada Newswire) - "Fresenius Kabi Canada announces that its tocilizumab biosimilar Tyenne referencing Actemra (tocilizumab) is now commercially available in Canada. Tyenne is the first and only tocilizumab biosimilar currently available in the country....Tyenne is indicated for the treatment of several inflammatory and immune diseases, including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), and systemic juvenile idiopathic arthritis (sJIA), cytokine release syndrome (CRS) and for the treatment of COVID-19."

Biosimilar launch • Idiopathic Arthritis • Immunology • Rheumatoid Arthritis

Cost-effectiveness analysis of subcutaneous biosimilar tocilizumab in patients with rheumatoid arthritis in Spain. (PubMed, Farm Hosp) - "bsTCZ demonstrated to be a cost-effective and cost-saving alternative for the treatment of patients with RA in Spain when compared to all the available therapeutic alternatives."

HEOR • Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

THRIVE: Tocilizumab-aazg for Hemorrhage: Reduction of Ischemic Vascular Events (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: University of Florida

New P1 trial • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Neutropenia • Subarachnoid Hemorrhage

Rheumatoid Arthritis, Cost-Effectiveness Analysis of Biosimilar Tocilizumab in Spain (ISPOR-EU 2024) - "The model included abatacept, biosimilar adalimumab, baricitinib, certolizumab, etanercept, filgotinib, golimumab, infliximab, rituximab, sarilumab, reference and biosimilar tocilizumab, tofacitinib, and upadacitinib... Biosimilar tocilizumab has proven to be a cost-effective alternative for the treatment of rheumatoid arthritis patients, even against the least expensive available biological or targeted synthetic DMARD comparator in Spain in a lifetime-horizon perspective."

Cost effectiveness • HEOR • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Cost-effectiveness analysis of subcutaneous biosimilar tocilizumab in patients with rheumatoid arthritis in Spain. (PubMed, Farm Hosp) - "bsTCZ demonstrated to be a cost-effective and cost-saving alternative for the treatment of patients with RA in Spain when compared to all the available therapeutic alternatives."

Cost effectiveness • HEOR • Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Safe Switching from Originator Tocilizumab to MSB11456 Tocilizumab Biosimilar in Subjects with Moderate-to-Severe Rheumatoid Arthritis: Efficacy, Safety and Immunogenicity Data Following Treatment Transition in a Pivotal, Randomized, Double-blind, Phase III Study (ACR Convergence 2024) - P3 | "Patients who transitioned from reference tocilizumab to MSB11456 at W24 demonstrated similar efficacy, safety, and immunogenicity during the full Transition Period up to W52 compared to the patients who continued with reference tocilizumab. Efficacy was sustained after transition with no impact on safety and immunogenicity."

Clinical • P3 data • Immunology • Infectious Disease • Inflammatory Arthritis • Novel Coronavirus Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology

CMS Grants Fresenius Kabi Permanent, Product-Specific Q-Code and Pass-Through Payment Status for Tyenne (tocilizumab-aazg) (Businesswire) - "Fresenius Kabi...announced today that the Centers for Medicare and Medicaid Services (CMS) issued a permanent, product-specific billing code and granted pass-through payment status for Tyenne (tocilizumab-aazg). Under the Healthcare Common Procedure Coding System (HCPCS), the Q-code assigned to Tyenne is effective for patients administered Tyenne on and after October 1, 2024. The new HCPCS Level II code for 'Injection, tocilizumab-aazg (Tyenne), biosimilar, 1 mg' is Q5135."

Reimbursement • Immunology

Fresenius Kabi launches Tyenne, the first and only approved tocilizumab biosimilar in Canada (Canada Newswire) - "Fresenius Kabi today launches its tocilizumab biosimilar Tyenne referencing Actemra (tocilizumab) in Canada. Tyenne is the first and only tocilizumab biosimilar currently available in Canada. Tyenne is indicated for the treatment of several inflammatory and immune diseases, including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), and systemic juvenile idiopathic arthritis (sJIA), cytokine release syndrome (CRS) and for the treatment of COVID-19...Tyenne offers patients and healthcare providers a flexible range of user-friendly subcutaneous (prefilled syringe and autoinjector) and intravenous (vials) administration....Fresenius Kabi provides support to Canadian patients prescribed Tyenne through its patient support program (PSP), KabiCare."

Biosimilar launch • Cytokine release syndrome • Giant Cell Arteritis • Idiopathic Arthritis • Immunology • Inflammation • Novel Coronavirus Disease • Rheumatoid Arthritis • Rheumatology

Modelling the opportunity for cost-savings or patient access with biosimilar adalimumab and tocilizumab: a European perspective. (PubMed, J Med Econ) - "Exclusive use of tocilizumab biosimilars (at a 30% discount) could increase savings to €28.8 to €113 million or expand access to an additional 43% of existing tocilizumab users across countries. This study demonstrates the benefits that can be realized through increased biosimilar adoption, not only in an untapped tocilizumab market, but also through incremental increases in well-established markets such as adalimumab. As healthcare budgets continue to face downwards pressure globally, strategies to increase biosimilar market share could prove useful to help manage financial constraints."

HEOR • Journal • Rheumatoid Arthritis

Fresenius Continues its Biopharma Momentum with Launch of Subcutaneous Formulation of Tyenne (tocilizumab-aazg) in the United States (Businesswire) - "Fresenius...announced today the immediate availability in the U.S. of its biosimilar Tyenne (tocilizumab-aazg), in a subcutaneous formulation, which will increase access to affordable and cost-effective treatment options for use in the treatment of chronic autoimmune diseases."

Biosimilar launch • Giant Cell Arteritis • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis

THE BUDGET IMPACT OF A TOCILIZUMAB BIOSIMILAR: A SPANISH PAYER PERSPECTIVE (EULAR 2024) - "The use of a tocilizumab biosimilar was projected to result in substantial savings in Spain, while providing a similar efficacy and safety profile as the reference product. In turn, these savings could be reinvested into the healthcare system, allowing more patients to be treated with an effective biologic without increasing current expenditure."

HEOR • Infectious Disease • Novel Coronavirus Disease • IL6

BUDGET IMPACT ANALYSIS OF A TOCILIZUMAB BIOSIMILAR: A UK PAYER PERSPECTIVE (EULAR 2024) - "The use of a tocilizumab biosimilar was projected to result in substantial savings in the UK, while providing a similar efficacy and safety profile as the reference product. In turn, these savings could be reinvested into the healthcare system, allowing more patients to be treated with an effective biologic without increasing current expenditure."

HEOR • Giant Cell Arteritis • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Novel Coronavirus Disease • Rheumatoid Arthritis • Rheumatology • IL6

ADALIMUMAB AND TOCILIZUMAB BIOSIMILARS IN EUROPE: BUDGET-IMPACT AND OPPORTUNITY FOR EXPANDED PATIENT ACCESS (EULAR 2024) - "The increased use of adalimumab biosimilars can provide additional savings and expanded treatment access. Moreover, the introduction of a tocilizumab biosimilar can be beneficial to several markets in Europe."

Clinical • HEOR

COST-EFFECTIVENESS ANALYSIS OF TOCILIZUMAB BIOSIMILAR IN PATIENTS WITH RHEUMATOID ARTHRITIS IN SPAIN (EULAR 2024) - " Cost-effectiveness analysis using a Markov model including the following health states: remission of the disease, low activity, moderate activity, high activity, and death; with a lifetime horizon and abatacept, adalimumab, baricitinib, certolizumab, etanercept, filgotinib, golimumab, infliximab, rituximab, sarilumab, biological tocilizumab, tofacitinib, and upadacitinib as the comparators... Tocilizumab biosimilar proved to be a cost-effective and a cost-saving alternative for the treatment of patients with rheumatoid arthritis in Spain when compared to all the available biological or targeted synthetic DMARDs therapeutic alternatives."

Clinical • Cost effectiveness • HEOR • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

RUBY: Real World Use of Tocilizumab Biosimilar studY (clinicaltrials.gov) - P=N/A | N=600 | Recruiting | Sponsor: Fresenius Kabi SwissBioSim GmbH | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world • Real-world evidence • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Fresenius Accelerates Momentum in its (Bio)Pharma Business and Launches Tyenne, its Third Approved Biosimilar in the U.S. (Businesswire) - "Fresenius, via its operating company Fresenius Kabi, announced today the immediate U.S. availability of Tyenne (tocilizumab-aazg), a biosimilar of Actemra (tocilizumab)."

Biosimilar launch • Giant Cell Arteritis • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Comparison of the Efficacy, Safety and Immunogenicity of a Proposed Biosimilar MSB11456 with Tocilizumab Reference Product in Moderate-to-Severe Rheumatoid Arthritis: Results of a Randomized Double-Blind Study (BSR 2024) - "Equivalent efficacy, immunogenicity and safety profiles of MSB11456 and EU‑approved tocilizumab were demonstrated in moderate-to-severe RA patients, confirming equivalence between MSB11456 and the EU‑approved tocilizumab."

Clinical • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • IL6R

Fresenius Kabi’s Biosimilar Tyenne (tocilizumab-aazg) Becomes the First IV and Subcutaneous Tocilizumab Biosimilar Approved by the FDA (Fresenius Kabi Press Release) - "Fresenius Kabi...announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Tyenne (tocilizumab-aazg), its tocilizumab biosimilar referencing Actemra (tocilizumab). Tyenne becomes the first tocilizumab biosimilar with both IV and subcutaneous formulations approved by the FDA. In accordance with its patent settlement agreement with Genentech, Fresenius Kabi has a license to market its tocilizumab products in the U.S. commencing on the license dates, which are confidential....Tyenne has launched globally in more than 10 countries, with plans to launch in many more countries between 2024 and 2025."

Biosimilar launch • BLA • Giant Cell Arteritis • Idiopathic Arthritis • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

RUBY: Real World Use of Tocilizumab Biosimilar studY (clinicaltrials.gov) - P=N/A | N=600 | Not yet recruiting | Sponsor: Fresenius Kabi SwissBioSim GmbH

New trial • Real-world • Real-world evidence • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology