In this study, tocilizumab-aazg (TYENNE) will be administered to see whether tocilizumab-aazg is safe in patients with a burst brain aneurysm and if it may prevent strokes in patients with a burst brain aneurysm.

Start Date01 Jul 2025

Sponsor / Collaborator

University of Florida

NCT04512001

/ CompletedPhase 3

A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union-approved RoActemra® in Patients With Moderately to Severely Active Rheumatoid Arthritis (APTURA I Study)

The purpose of the study is to compare the efficacy, safety and immunogenicity of MSB11456 and EU approved RoActemra® in participants with moderately to severely active rheumatoid arthritis.
Participants will be randomized at the beginning of the Core Treatment Period (Baseline to Week 24) to receive either MSB11456 or EU approved RoActemra® once a week (QW). At the beginning of the Extended Treatment Period (Week 24 to Week 52), participants who received RoActemra® will be re-randomized to either continue receiving RoActemra® QW or switch to receive MSB11456 QW.

Start Date03 Aug 2020

Sponsor / Collaborator

Fresenius Kabi SwissBioSim GmbH

EUCTR2019-004369-42-BG

/ Unknown statusPhase 3

A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I

Start Date28 May 2020

Sponsor / Collaborator

Fresenius Kabi SwissBioSim GmbH

100 Clinical Results associated with Tocilizumab-aazg

100 Translational Medicine associated with Tocilizumab-aazg

100 Patents (Medical) associated with Tocilizumab-aazg

Literatures (Medical) associated with Tocilizumab-aazg

01 Feb 2024·RMD Open

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

Article

Author: Baker, Peter ; Petit-Frere, Corinne ; Zubrzycka-Sienkiewicz, Anna ; Klama, Kamilla ; Illes, Andras ; Ullmann, Martin ; Monnet, Joëlle

ObjectiveTo evaluate the efficacy, immunogenicity and safety of the proposed biosimilar MSB11456 versus European Union (EU)-approved tocilizumab reference product in patients with rheumatoid arthritis (RA) in a multicentre, randomised, double-blind, multinational, parallel-group study (NCT04512001).MethodsAdult patients with moderate-to-severe active RA and inadequate clinical response to ≥1 disease-modifying antirheumatic drug (synthetic or biologic) receiving methotrexate were randomised to receive 24 weekly subcutaneous 162 mg injections of either MSB11456 or EU-approved tocilizumab. Equivalence between treatments was considered if the 95% CI (European Medicines Agency)/90% CI (US Food and Drug Administration) for the difference in mean change from baseline to week 24 in Disease Activity Score-28 Joint Count with erythrocyte sedimentation rate (DAS28-ESR) between treatments was entirely within prespecified equivalence intervals (−0.6 to 0.6 and −0.6 to 0.5, respectively). At week 24, patients were rerandomised to continued treatment or MSB11456. Secondary efficacy endpoints to week 52, and safety and immunogenicity to week 55 were also evaluated.ResultsAt week 24, the least squares mean difference in the change from baseline in DAS28-ESR between treatments was 0.01 (95% CI −0.19 to 0.22) in the 604 randomised patients. Similarity between treatments was shown for all other efficacy, safety and immunogenicity endpoints, including in patients who switched from EU-approved tocilizumab to MSB114466.ConclusionsTherapeutic 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.

03 Apr 2023·Expert Review of Clinical Immunology

Pharmacokinetics of a proposed tocilizumab biosimilar (MSB11456) versus US-licensed tocilizumab: results of a randomized, double-blind, single-intravenous dose study in healthy adults

Article

Author: Petit-Frere, Corinne ; Illes, Andras ; Tomaszewska-Kiecana, Monika ; Monnet, Joëlle ; Dagres, Christos ; Ullmann, Martin

BACKGROUNDTocilizumab, a recombinant monoclonal immunoglobulin G, targets the interleukin-6 receptor. MSB11456 is a proposed tocilizumab biosimilar.OBJECTIVESTo assess pharmacokinetic equivalence of intravenous MSB11456 to US-licensed tocilizumab.RESEARCH DESIGN AND METHODSIn this double-blind, parallel-group, single-dose study, 128 healthy adults were randomized to a single one-hour 8 mg/kg IV infusion of either MSB11456 or US-licensed tocilizumab. Blood samples were collected pre-dose and at regular intervals up to day 48 post-dose. The primary endpoint pharmacokinetic parameter was analyzed using analysis of variance (ANOVA) model on the natural logarithm of the endpoint (AUC_0-last), with treatment as a fixed effect. Immunogenicity and safety data were summarized descriptively.RESULTSSubjects received either MSB11456 (N = 62) or US-licensed tocilizumab (N = 66). Pharmacokinetic bioequivalence, defined as 90% confidence intervals for the geometric least squares mean ratio entirely contained within the 80.00% to 125.00% equivalence limits, was demonstrated between MSB11456 and US-licensed tocilizumab for the primary and secondary pharmacokinetic endpoints. Anti-drug antibody responses, frequency of neutralizing antibodies against tocilizumab, and safety profiles showed no notable between-treatment differences. Safety was comparable between treatments.CONCLUSIONSPharmacokinetic similarity of MSB11456 and US-licensed tocilizumab was demonstrated, with comparable immunogenicity and safety profiles, supporting MSB11455 as a biosimilar to US-licensed tocilizumab. The trial is registered at EudraCT, number 2019-003484-22.

03 Apr 2023·Expert Review of Clinical Immunology

Pharmacokinetics and tolerability of prefilled syringe and auto-injector presentations of MSB11456: results of a randomized, single-dose study in healthy adults

Article

Author: Illes, Andras ; Dagres, Christos ; Monnet, Joëlle ; Petit-Frere, Corinne ; Dryja, Anna ; Tomaszewska-Kiecana, Monika ; Ullmann, Martin

BACKGROUNDTocilizumab is a monoclonal immunoglobulin G interleukin-6 receptor antagonist. MSB11456 is a proposed tocilizumab biosimilar.OBJECTIVETo determine the pharmacokinetic equivalence of a single subcutaneous injection of MSB11456, when delivered via autoinjector (AI) and prefilled syringe (PFS), in healthy adult subjects.RESEARCH DESIGN AND METHODSIn this randomized, open-label, single fixed-dose, crossover study, 91 subjects received subcutaneous administration of tocilizumab 162 mg via AI and PFS presentations. The primary endpoint pharmacokinetic parameters were analyzed using analysis of variance. Safety data were summarized descriptively.RESULTSThere were no differences in pharmacokinetic parameters between presentations, and safety parameters were comparable. The 90% confidence intervals for the geometric least squares mean ratios of all primary pharmacokinetic parameters were contained within the predefined 80.00% to 125.00% bioequivalence limits, indicating pharmacokinetic equivalence between the AI and PFS.CONCLUSIONSMSB11456 administration via AI was bioequivalent to administration via PFS. MSB11456 can be administered by AI or PFS, increasing the available range of self-injection devices.TRIAL REGISTRATIONThe trial is registered at EudraCT, number 2020-003419-86.

News (Medical) associated with Tocilizumab-aazg

03 Mar 2025

·pipelinereview.com

Fresenius Continues Growth of Biosimilars Portfolio with the U.S. Availability of Otulfi® (ustekinumab-aauz)

LAKE ZURICH, IL, USA I March 03, 2025 I Fresenius Kabi, an operating company of Fresenius, and Formycon AG, a leading, independent developer of high-quality biosimilars, announced today that the ustekinumab biosimilar Otulfi ® (ustekinumab-aauz) developed by Formycon AG, is now available in the United States. Otulfi ® is an ustekinumab biosimilar for the reference product Stelara ® (ustekinumab). Otulfi ® is indicated for the treatment of moderately to severely active Crohn’s disease and ulcerative colitis in adult patients, moderate to severely plaque psoriasis for adult patients and pediatric patients six years or older, who are candidates for phototherapy or systemic therapy, and active psoriatic arthritis in adults and pediatric patients six years or older. The development and commercialization of the ustekinumab biosimilar is the first biosimilar product launched in the U.S. from the partnership between Fresenius and Formycon AG . In February 2023, Fresenius and Formycon entered a global commercialization partnership for the ustekinumab biosimilar covering key global markets. The drug received FDA approval in September 2024. “The U.S. availability of Otulfi demonstrates our commitment to serving patients and clinicians. Through the expansion of our biopharma portfolio, we are able to do this globally and, in the U.S.,” said Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board. “In addition to approving Otulfi last year for all indications matching the reference product Stelara, the FDA has also granted a provisional determination of interchangeability for Otulfi.” Otulfi will be available in the U.S. in the following presentations: a 45 mg/0.5 mL and 90 mg/mL single-dose prefilled syringe for injection and a 130 mg/26 mL (5 mg/mL) single dose vial for IV infusion. Otulfi in a 45 mg/0.5 mL single-dose vial for subcutaneous injection is expected to receive FDA approval in the first half of 2025. About Otulfi Otulfi (ustekinumab-aauz) is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. The FDA approval of Otulfi (ustekinumab-aauz) was based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. Otulfi demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Stelara® in patients with moderate to severe plaque psoriasis. Otulfi was approved for both subcutaneous and intravenous formulations which will offer a comprehensive, alternative treatment solution for health care professionals and patients treated with ustekinumab in the U.S. Otulfi (ustekinumab-aauz) is the fourth Fresenius biosimilar commercialized in the U.S., following the approvals and launches of Idacio ® (adalimumab-aacf), Tyenne ® (tocilizumab-aazg) and Stimufend ® (pegfilgrastim-fpgk). Fresenius’s growing pipeline of autoimmune and oncology biosimilars has several molecules in early and late-stage development. Indications OTULFI (ustekinumab-aauz) is an IL-12/23 antagonist indicated for treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderately to severely active Crohn’s disease; moderately to severely active ulcerative colitis. Otulfi is also indicated for pediatric patients ≥6 years of age with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis. Please click to see full Prescribing Information and Medication Guide for Otulfi ® (ustekinumab-aauz) here . About Fresenius Kabi As a global health care company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 43,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies. In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status – notably as the only corporation offering both product groups. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care. Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of almost 450 million patients annually. With Vision 2026, as part of the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of health care. Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing health care solutions on a global scale. For more information, please visit www.fresenius-kabi.com and www.fresenius-kabi.com/us in the United States. About Formycon Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, have been approved by the FDA, EMA, and MHRA; FYB202 is also approved in Canada. Another four biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon AG is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX and TecDAX selection indices. Further information can be found at: https://www.formycon.com . This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release. Management Board: Pierluigi Antonelli (Chairman), Marc Crouton, Andreas Duenkel, Dr. Christian Hauer, Dr. Marc-Alexander Mahl, Dr. Sang-Jin Pak Chairman of the Supervisory Board: Michael Sen Registered Office: Bad Homburg, Germany Commercial Register: Amtsgericht Bad Homburg – HRB 11654 Otulfi ® (ustekinumab-aauz) is a trademark of Fresenius Kabi Deutschland GmbH in selected countries. Stelara ® is a registered trademark of Johnson & Johnson. Idacio ® (adalimumab-aacf) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries. Tyenne ® (tocilizumab-aazg) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries. Stimufend ® (pegfilgrastim-fpgk) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries. SOURCE: Fresenius Kabi

Drug ApprovalBiosimilar

30 Sep 2024

·www.biospace.com

Fresenius Kabi and Formycon Receive U.S. FDA Approval for Biosimilar Otulfi™* (ustekinumab-aauz)

Otulfi™ received FDA approval for both subcutaneous and intravenous formulations, to treat the same conditions as Stelara®** Otulfi™ expands Fresenius Kabi’s U.S. biosimilars portfolio focused on immunology and oncology In accordance with the patent settlement between Fresenius Kabi, Formycon and Johnson & Johnson, Fresenius Kabi has the right to market Otulfi™ in the U.S. no later than February 22, 2025 BAD HOMBURG, Germany--(BUSINESS WIRE)-- #FreseniusKabi --Fresenius Kabi, an operating company of Fresenius, specializing in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, and Formycon AG, a leading, independent developer of high-quality biosimilars, announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Otulfi™ (ustekinumab-aauz), its ustekinumab biosimilar referencing Stelara ® ** (ustekinumab). Otulfi™ is approved for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. Fresenius Kabi is further continuing its momentum, striving at expanding its strong Biopharma platform, which is a substantial cornerstone of #FutureFresenius. “The FDA approval of Otulfi™, Fresenius Kabi’s fourth biosimilar product in the U.S. market, is an important milestone on our pathway to consistently broadening our biopharma portfolio in the U.S. and worldwide. In line with our Vision 2026 growth strategy, we are fully committed to becoming a significant player in the biopharma field and offering essential treatment options for patients globally,” said Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board. In February 2023, Fresenius Kabi and Formycon entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets. Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. The FDA approval of Otulfi™ (ustekinumab-aauz) is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. Otulfi™ demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Stelara ® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). Otulfi™ was approved for both subcutaneous and intravenous formulations which will offer a comprehensive, alternative treatment solution for health care professionals and patients treated with ustekinumab in the U.S. Otulfi™ is contraindicated in patients with significant hypersensitivity to ustekinumab or to any of the excipients. Please see Important Safety Information for Otulfi here . Otulfi™ (ustekinumab-aauz) is Fresenius Kabi’s fourth biosimilar granted a marketing authorization in the U.S., following previous approvals of its commercially available biosimilars Idacio ® *** (adalimumab-aacf), Tyenne ® **** (tocilizumab-aazg) and Stimufend ® ***** (pegfilgrastim-fpgk). Fresenius Kabi’s growing pipeline of autoimmune and oncology biosimilars has several molecules in early and late-stage development. ___ * Otulfi™ (ustekinumab-aauz) is a trademark of Fresenius Kabi Deutschland GmbH in selected countries ** Stelara ® is a registered trademark of Johnson & Johnson *** Idacio ® (adalimumab-aacf) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries **** Tyenne ® (tocilizumab-aazg) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries ***** Stimufend ® (pegfilgrastim-fpgk) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries About Fresenius Kabi Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients. Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face. Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders. About Formycon Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and the U.S.A. Another five biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon AG is headquartered in Munich and is listed on the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release. Management Board: Pierluigi Antonelli (Chairman), Marc Crouton, Andreas Duenkel, Dr. Christian Hauer, Dr. Marc-Alexander Mahl, Dr. Sang-Jin Pak Chairman of the Supervisory Board: Michael Sen Registered Office: Bad Homburg, Germany Commercial Register: Amtsgericht Bad Homburg - HRB 11654 Contacts Matt Kuhn matt.kuhn@fresenius-kabi.com 847-220-3033

Drug ApprovalBiosimilar

02 Jul 2024

·www.biospace.com

Fresenius Continues its Biopharma Momentum with Launch of Subcutaneous Formulation of Tyenne® (tocilizumab-aazg) in the United States

Tyenne® is the first tocilizumab biosimilar available with both an intravenous and subcutaneous formulation approved by the FDA. The subcutaneous formulation of the tocilizumab biosimilar provides increased access and an affordable treatment option for U.S. patients. Subcutaneous formulation was approved by FDA and is available in a self-administered prefilled syringe and an autoinjector. Third Fresenius Kabi biosimilar in the U.S. and second in its immunology portfolio. LAKE ZURICH, Ill.--(BUSINESS WIRE)-- Fresenius, via its operating company Fresenius Kabi, 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. This press release features multimedia. View the full release here: Tyenne® from Fresenius Kabi is the first tocilizumab biosimilar approved by the FDA that is available in both an intravenous and subcutaneous formulation. The subcutaneous formulation is now available in a self-administered prefilled syringe and an autoinjector. (Photo: Business Wire) Tyenne is indicated for use in the treatment of chronic autoimmune diseases for certain indications of the reference product, Actemra® (tocilizumab). Fresenius Kabi previously launched Tyenne® in an intravenous (IV) formulation in April of this year. “After successfully launching Tyenne in more than 10 countries, we are on track to continue the momentum in the U.S with the launch of a second formulation,” said Sang-Jin Pak, M.D., President of Biopharma at Fresenius Kabi. “Introducing our subcutaneous formulation demonstrates our continued commitment to providing greater access to more patients living with autoimmune diseases.” Trial data that compared Tyenne® to the reference product, Actemra® showed similar safety and tolerability. Tyenne® is the first tocilizumab biosimilar with an intravenous and subcutaneous formulation approved by the FDA. Tyenne® received FDA approval on March 5, 2024, and an IV formulation was launched in April 2024 for use in the treatment of several inflammatory autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. To learn more about how Fresenius Kabi provides comprehensive patient support for Tyenne® in the U.S. please click here. About Tyenne®, a Tocilizumab Biosimilar Tyenne® (tocilizumab-aazg), a biosimilar to Actemra® (tocilizumab), is a prescription medicine called an Interleukin-6 (IL-6) receptor antagonist. It was developed by Fresenius Kabi using advanced analytical and manufacturing technologies for use in the treatment of several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. Tyenne® includes a Boxed Warning for serious infections leading to hospitalization or death including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections that have occurred in patients receiving tocilizumab products. Tyenne® is contraindicated in patients with known hypersensitivity to tocilizumab products. For more information about Tyenne®, please see the important safety information and full prescribing information for the U.S. About Fresenius Kabi Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients. Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face. Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leader globally in its product segments – all for the benefit of patients, its customers, and its stakeholders. Fresenius SE & Co. KGaA (Frankfurt/Xetra: FRE) is a global healthcare company headquartered in Bad Homburg v. d. Höhe, Germany. In the 2023 fiscal year, Fresenius generated €22.3 billion in annual revenue with its more than 190,000 employees. Fresenius offers solutions to the social challenges posed by a growing and ageing population and the resulting need for affordable, high-quality healthcare. The Fresenius Group comprises the operating companies Fresenius Kabi and Fresenius Helios as well as the investment companies Fresenius Vamed and Fresenius Medical Care. With 140 hospitals and countless outpatient facilities, Fresenius Helios is the leading private hospital operator in Germany and Spain, treating around 26 million patients every year. Fresenius Kabi’s product portfolio includes a range of highly complex biopharmaceuticals, clinical nutrition, medical technology, and generic intravenous drugs. Fresenius was established in 1912 by the Frankfurt pharmacist Dr. Eduard Fresenius. After his death, Else Kröner took over management of the company in 1952. She laid the foundations for a global enterprise that today pursues the goal of improving people’s health. The largest shareholder is the non-profit Else Kröner-Fresenius Foundation, which is dedicated to advancing medical research and supporting humanitarian projects. For more information visit the company website at . Follow us on social media: . This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, the availability of financing and unforeseen impacts of international conflicts. Fresenius does not undertake any responsibility to update the forward-looking statements in this release. Fresenius SE & Co. KGaA Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11852 Chairman of the Supervisory Board: Wolfgang Kirsch General Partner: Fresenius Management SE Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11673 Management Board: Michael Sen (Chairman), Pierluigi Antonelli, Sara Hennicken, Robert Möller, Dr. Michael Moser Chairman of the Supervisory Board: Wolfgang Kirsch Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group. Tyenne® is a registered trademark of Fresenius Kabi Deutschland GmbH.

Drug ApprovalExecutive Change

100 Deals associated with Tocilizumab-aazg

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
COVID-19	European Union	Fresenius Kabi Deutschland GmbH	15 Sep 2023
COVID-19	Norway	Fresenius Kabi Deutschland GmbH	15 Sep 2023
COVID-19	Liechtenstein	Fresenius Kabi Deutschland GmbH	15 Sep 2023
COVID-19	Iceland	Fresenius Kabi Deutschland GmbH	15 Sep 2023
Cytokine Release Syndrome	Norway	Fresenius Kabi Deutschland GmbH	15 Sep 2023
Cytokine Release Syndrome	Iceland	Fresenius Kabi Deutschland GmbH	15 Sep 2023
Cytokine Release Syndrome	Liechtenstein	Fresenius Kabi Deutschland GmbH	15 Sep 2023
Cytokine Release Syndrome	European Union	Fresenius Kabi Deutschland GmbH	15 Sep 2023
Polyarticular Juvenile Idiopathic Arthritis	Liechtenstein	Fresenius Kabi Deutschland GmbH	15 Sep 2023
Polyarticular Juvenile Idiopathic Arthritis	Norway	Fresenius Kabi Deutschland GmbH	15 Sep 2023
Polyarticular Juvenile Idiopathic Arthritis	European Union	Fresenius Kabi Deutschland GmbH	15 Sep 2023
Polyarticular Juvenile Idiopathic Arthritis	Iceland	Fresenius Kabi Deutschland GmbH	15 Sep 2023
Rheumatoid Arthritis	European Union	Fresenius Kabi Deutschland GmbH	15 Sep 2023
Rheumatoid Arthritis	Liechtenstein	Fresenius Kabi Deutschland GmbH	15 Sep 2023
Rheumatoid Arthritis	Iceland	Fresenius Kabi Deutschland GmbH	15 Sep 2023
Rheumatoid Arthritis	Norway	Fresenius Kabi Deutschland GmbH	15 Sep 2023
Systemic onset juvenile chronic arthritis	European Union	Fresenius Kabi Deutschland GmbH	15 Sep 2023
Systemic onset juvenile chronic arthritis	Norway	Fresenius Kabi Deutschland GmbH	15 Sep 2023
Systemic onset juvenile chronic arthritis	Liechtenstein	Fresenius Kabi Deutschland GmbH	15 Sep 2023
Systemic onset juvenile chronic arthritis	Iceland	Fresenius Kabi Deutschland GmbH	15 Sep 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Phase 1	Georgia	Fresenius Kabi SwissBioSim GmbH	03 Aug 2020
Rheumatoid Arthritis	Phase 1	Russia	Fresenius Kabi SwissBioSim GmbH	03 Aug 2020
Rheumatoid Arthritis	Phase 1	Serbia	Fresenius Kabi SwissBioSim GmbH	03 Aug 2020
Rheumatoid Arthritis	Phase 1	Moldova	Fresenius Kabi SwissBioSim GmbH	03 Aug 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2024	Not Applicable	-	-	Tocilizumab biosimilar	pocgzdsohm(hszofdgojq) = hrltnjqbvf fvwraqowqe (ntlssbejbw )	-	05 Jun 2024
EULAR2024	Not Applicable	interleukin-6	-	Tocilizumab biosimilar	cizlqlgeub(jvawxgvrjv) = dadqdylwgg ayzrkfhvdv (gsvamuritk )	Positive	05 Jun 2024
EULAR2023	Not Applicable	Rheumatoid Arthritis	-	MSB11456	(tcdhkvoxes) = ulganfhpnt qsgvkotnqu (aeizgvyzzz ) View more	Positive	31 May 2023
EULAR2023	Not Applicable	Rheumatoid Arthritis	-	EU-approved tocilizumab	(tcdhkvoxes) = eanbfygvtq qsgvkotnqu (aeizgvyzzz ) View more	Positive	31 May 2023
NCT04512001 (CTgov)	Phase 3	Rheumatoid Arthritis	604	MSB11456	wrxbyrfzzk(mivrrskgpc) = bdicqggfza fgwmnywopm (qucadynkpj, kygofqbdeg - fqimyvobhj) View more	-	24 Oct 2022

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