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

Use of FK-tocilizumab biosimilar (MSB11456) in rheumatoid arthritis patients: 6 months data of the international real-world study RUBY (EULAR 2025) - No abstract available

Clinical • Real-world • Real-world evidence • 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."

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

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 (Aptura I) (CRA-AHPA 2024) - "Equivalent efficacy and similar immunogenicity and safety profiles of MSB11456 and EU-approved tocilizumab were demonstrated in patients with moderate-to-severe RA."

Clinical • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Comparison of the efficacy and safety of a proposed biosimilar MSB11456 with tocilizumab reference product in subjects with moderate-to-severe rheumatoid arthritis: results of a randomised double-blind study. (PubMed, RMD Open) - P3 | "Therapeutic equivalence was demonstrated for efficacy endpoints, and safety and immunogenicity analyses support the similarity of the two treatments. The results of this study strengthen the evidence that the proposed biosimilar MSB11456 and EU-approved tocilizumab exert similar clinical effects."

Journal • 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 (ACR Convergence 2023) - P3 | "Equivalent efficacy, and similar immunogenicity and safety profiles of MSB11456 and EU-approved tocilizumab were demonstrated in patients with moderate to severe RA."

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

Fresenius Kabi launches Tyenne, the first approved tocilizumab biosimilar in the European Union (Fresenius Kabi Press Release) - "Fresenius Kabi announced today the launch of its tocilizumab biosimilar Tyenne^® referencing RoActemra^® (tocilizumab) in the European Union....Tyenne^® becomes the first tocilizumab biosimilar available in Europe for the treatment of several inflammatory and immune diseases."

Biosimilar launch • Idiopathic Arthritis • Immunology • Inflammation • Rheumatoid Arthritis

EU has its first RoActemra biosimilar, from Fresenius Kabi (pharmaphorum) - "The European Commission has approved the first biosimilar version of Actemra/RoActemra, Roche’s $3 billion blockbuster, from German drugmaker Fresenius Kabi. The biosimilar of IL-6 inhibitor tocilizumab, called Tyenne (formerly MSB11456), has been approved for the same indications as Roche’s brand, including rheumatoid arthritis, systemic juvenile idiopathic arthritis (sJIA), juvenile idiopathic polyarthritis (pJIA), giant cell arteritis (GCA), CAR-T cell-induced severe or life-threatening cytokine release syndrome and severe COVID-19."

European regulatory • Giant Cell Arteritis • Idiopathic Arthritis • Immunology • Inflammatory Arthritis • Novel Coronavirus Disease • Rheumatoid Arthritis • Rheumatology

Fresenius Kabi’s tocilizumab biosimilar receives positive opinion on Marketing Authorization Application (MAA) for Europe (PipelineReview) - "Fresenius Kabi...announced today that the EMA CHMP has adopted a positive opinion recommending the granting of a marketing authorization for its tocilizumab biosimilar candidate MSB11456 referencing RoActemra®* (tocilizumab). MSB11456 becomes the first tocilizumab biosimilar candidate to be granted a positive opinion by the CHMP for the treatment of several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis, cytokine release syndrome, as well as for COVID-19. The positive opinion covers both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations which offer a comprehensive, alternative treatment solution for patients treated with tocilizumab."

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