A Randomised, Double-blind, Parallel-group, Phase 3 Study to Compare the Efficacy, Safety, and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara® in Patients With Moderate-to-Severe Plaque Psoriasis

This is a randomized, double-blind, multicenter study to evaluate the efficacy, safety, and immunogenicity of FYB202 compared to Stelara® in patients with Moderate-to-Severe Plaque Psoriasis.

Start Date09 Nov 2020

Sponsor / Collaborator

bioeq GmbH

100 Clinical Results associated with Ustekinumab-Aauz

100 Translational Medicine associated with Ustekinumab-Aauz

100 Patents (Medical) associated with Ustekinumab-Aauz

Literatures (Medical) associated with Ustekinumab-Aauz

01 May 2025·ADVANCES IN THERAPY

A Randomised, Double-Blind Trial to Compare the Efficacy, Safety, and Immunogenicity of the Biosimilar Ustekinumab FYB202 with Reference Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis

Article

Author: Freudensprung, Brigitte ; Nopora, Katrin ; Balser, Sigrid ; Trieb, Michael ; Papp, Kim ; Rewerski, Piotr

INTRODUCTION:

Biosimilars allow more patients access to affordable treatment options and help reduce the financial burden on healthcare systems. This multicentre trial compared the efficacy, safety, and immunogenicity of the approved biosimilar ustekinumab FYB202 with reference ustekinumab.

METHODS:

Eligible patients were ≥ 18 years old with stable moderate-to-severe plaque psoriasis for ≥ 6 months and inadequate treatment response to or intolerance of ≥ 1 previous systemic treatment. Patients were randomised (1:1) to double-blind treatment with FYB202 or reference ustekinumab; patients in the reference group who achieved Psoriasis Area and Severity Index (PASI) 75 percent improvement at week 28 were re-randomised to FYB202 or reference product. The primary efficacy endpoint was percent improvement in PASI score from baseline to week 12. Therapeutic equivalence was demonstrated if, depending on the regulatory requirement with respect to the significance level, the two-sided 95% and 90% confidence intervals (CIs) were within the pre-defined equivalence intervals of ± 11% and ± 10%, respectively.

RESULTS:

A total of 392 patients were randomised to FYB202 (n = 197) or reference ustekinumab (n = 195). Baseline characteristics were well balanced between groups. Mean percent improvement in PASI score at week 12 was equivalent between FYB202 and reference ustekinumab with an estimated least-squares mean treatment difference of 3.27% and the two-sided 95% (- 0.90%, 7.44%) and 90% (- 0.22%, 6.77%) CIs fully contained within the pre-defined equivalence margins. Safety and immunogenicity profiles were comparable between groups. Switching from reference product to FYB202 had no clinically relevant effect on efficacy, safety, or immunogenicity.

CONCLUSION:

FYB202 demonstrated therapeutic equivalence to reference ustekinumab in patients with moderate-to-severe plaque psoriasis.

TRIAL REGISTRATION:

NCT04595409; EudraCT 2019-004364-21.

01 Dec 2024·Clinical Pharmacology in Drug Development

New Ustekinumab Biosimilar Candidate FYB202: Pharmacokinetic Equivalence Demonstrated in a Randomized, Double‐Blind, Parallel‐Group, Single‐Dose Trial in Healthy Subjects

Article

Author: Wedemeyer, Ralph‐Steven ; Anschütz, Maria ; Nopora, Katrin ; Balser, Sigrid ; Schug, Barbara ; Körner, Juliane

Abstract:

In the RUSTIC trial, pharmacokinetic (PK) similarity between the proposed ustekinumab biosimilar FYB202 and EU‐approved (EU‐Ref) and US‐licensed ustekinumab (US‐Ref) as well as between both reference drugs was assessed after a single 45‐mg subcutaneous injection. Safety analyses comprised immunogenicity (antidrug antibodies, neutralizing antibodies), adverse events, and local tolerability. Overall, 491 healthy adults were randomized 1:1:1 and observed for up to 112 days; 486 completed the trial, and 478 were included in the PK analysis. All 3 comparisons showed PK similarity, since the 90% confidence intervals of the respective geometric mean ratios for area under the concentration‐time curve from time 0 to infinity and maximum serum concentration were contained within the acceptance interval of 80%‐125%. No clinically meaningful differences regarding overall safety, immunogenicity, and local tolerability were observed. Notably, after FYB202 administration, in fewer subjects at least 1 positive antidrug antibody result was observed compared to the reference groups (FYB202, 20%; EU‐Ref, 42%; US‐Ref, 51%). In conclusion, the RUSTIC trial demonstrated equivalent PK characteristics for FYB202 when compared to both EU‐Ref and US‐Ref ustekinumab and between both reference drugs. It provides the basis for the marketing authorization of FYB202, together with an extensive analytical characterization and the results of a confirmatory efficacy and safety trial in patients with moderate to severe plaque psoriasis.

News (Medical) associated with Ustekinumab-Aauz

19 May 2025

·www.businesswire.com

FDA Grants Interchangeable Designation to Fresenius Kabi’s biosimilar Otulfi ® (ustekinumab-aauz)

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced today that the U.S. Food and Drug Administration (FDA) designated Otulfi® (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara® (ustekinumab). Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced today that the U.S. Food and Drug Administration (FDA) designated Otulfi® (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara® (ustekinumab). Depending on state pharmacy laws in the U.S., an interchangeable biosimilar can be dispensed at the pharmacy as a substitute for the reference product without requiring direct approval from the prescribing healthcare provider. Not all biosimilars receive interchangeability status. “Fresenius Kabi is pleased to receive this interchangeable designation for Otulfi, and we will continue to evaluate all possibilities in the development and commercialization of our biosimilar portfolio that help create access for patients and healthcare professionals to important, high-quality and affordable therapies,” said Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board. According to recent FDA draft guidance, biosimilar applicants can request an interchangeability designation using existing data from their Biologics License Application (BLA). Previously, the FDA granted this status only to biosimilars that submitted multiple switch studies meeting additional data criteria. This demonstrates that patients who alternated between the reference product and the biosimilar, then returned to the reference product, exhibited no clinically meaningful differences in safety, efficacy, or immunogenicity. This ensures the same clinical outcome for patients treated exclusively with the reference product. About Otulfi 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 Kabi and Formycon AG. In February 2023, Fresenius Kabi and Formycon entered a global commercialization partnership for the ustekinumab biosimilar covering key global markets. The drug received FDA approval in September 2024 and has been available in the U.S. since March 2025. 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 Kabi biosimilar commercialized in the U.S., following the approvals and launches of 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. 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. IMPORTANT SAFETY INFORMATION Otulfi (ustekinumab-aauz) is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in Otulfi (ustekinumab-aauz). Infections Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products. Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following: Plaque psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, urinary tract infections; Psoriatic arthritis: cholecystitis; Crohn’s disease: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, Listeria meningitis and Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, listeriosis. Avoid initiating treatment with Otulfi (ustekinumab-aauz) in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of Otulfi (ustekinumab-aauz) in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with Otulfi (ustekinumab-aauz). Discontinue Otulfi (ustekinumab-aauz) for serious or clinically significant infections until the infection resolves or is adequately treated. Theoretical Risk for Vulnerability to Particular Infections Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), Salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections. Consider appropriate diagnostic testing (e.g., tissue culture, stool culture, as dictated by clinical circumstances). Pre-Treatment Evaluation of Tuberculosis (TB) Evaluate patients for TB prior to initiating treatment with Otulfi (ustekinumab-aauz). Avoid administering Otulfi (ustekinumab-aauz) to patients with active TB infection. Initiate treatment of latent TB before administering Otulfi (ustekinumab-aauz). Consider anti-TB therapy prior to initiation of Otulfi (ustekinumab-aauz) in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving Otulfi (ustekinumab-aauz) for signs and symptoms of active TB during and after treatment. Malignancies Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among subjects who received ustekinumab in clinical trials. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy. The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer (NMSC). Monitor all patients receiving Otulfi (ustekinumab-aauz) for the appearance of NMSC. Closely follow patients >60 years of age, those with a medical history of prolonged immunosuppressant therapy, and those with a history PUVA treatment. Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue Otulfi (ustekinumab-aauz). Posterior Reversible Encephalopathy Syndrome (PRES) Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis and Crohn’s disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after initiating ustekinumab products. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab. Monitor all patients treated with Otulfi (ustekinumab-aauz) for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue Otulfi (ustekinumab-aauz). Immunizations Prior to initiating therapy with Otulfi (ustekinumab-aauz), patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with Otulfi (ustekinumab-aauz) should not receive live vaccines. Avoid administering BCG vaccines during treatment with Otulfi (ustekinumab-aauz), or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving Otulfi (ustekinumab-aauz) because of the potential risk for shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of Otulfi (ustekinumab-aauz) may not elicit an immune response sufficient to prevent disease. Noninfectious Pneumonia Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases, administration of corticosteroids. If diagnosis is confirmed, discontinue Otulfi (ustekinumab-aauz) and institute appropriate treatment. Most Common Adverse Reactions The most common adverse reactions (≥3%) seen in patients treated with Otulfi (ustekinumab-aauz) are: Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, fatigue; Crohn’s disease, induction: vomiting; Crohn’s disease, maintenance: nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis; Ulcerative colitis, induction: nasopharyngitis and Ulcerative colitis, maintenance: nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, nausea. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or to report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please click to see full Prescribing Information and Medication Guide for Otulfi® (ustekinumab-aauz) here. 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. 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 41,000 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 450 million patients annually. In keeping with 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. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn and Facebook. Otulfi® (ustekinumab-aauz) is a trademark of Fresenius Kabi Deutschland GmbH in selected countries. Stelara® is a registered trademark of Johnson & Johnson. 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.

Drug ApprovalClinical Result

07 May 2025

·www.fresenius.com

Fresenius Q1/25: Strong start to 2025 – #FutureFresenius Rejuvenate phase kicked-off with excellent momentum

Contact Timo Lindemann T +49 (0) 6172 608-7939 timo.lindemann@fresenius.com Documents Text as PDF document (PDF, 227 KB) An overview of key financial figures is available at the end of the release. Q1/2025: Strong top line and excellent EPS growth, outlook confirmed Group revenue 1 at €5.63 billion with strong organic growth of 7% 1,2 driven by consistent delivery of Fresenius Kabi and a strong performance at Fresenius Helios. Group EBIT 1 at €654 million, increase of 4% 3 in constant currency on the back of strong operating performance at Kabi; absence of energy relief payments weighing on Helios Germany; Group EBIT margin 1 of 11.6%. Net income 1,4 grew by an excellent 12% 3 in constant currency to €416 million significantly outpacing revenue growth EPS 1,4 rose by excellent 12% 3 in constant currency to €0.74 resulting from broad based operational strength and lower interest expenses. Operating cash flow from continuing operations of €74 million significantly improved year-on-year driven by operating development and increased focus on cash generation. Leverage ratio within target corridor: Net debt/EBITDA ratio at 3.0x 1,5 showing 80 bps improvement in the last twelve months. #FutureFresenius Rejuvenate phase : Pivotal milestone delivered with the reduction of participation in Fresenius Medical Care stake enhancing strategic flexibility while setting basis for long-term profitable growth. 1 Before special items 2 Organic growth rate adjusted for accounting effects related to Argentina hyperinflation. 3 Growth rate adjusted for Argentina hyperinflation. 4 Excluding Fresenius Medical Care 5 At average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures, including lease liabilities, including Fresenius Medical Care dividend, net debt adjusted for the valuation effect of the equity-neutral exchangeable bond. Michael Sen, CEO of Fresenius: “We've kick-started 2025 with an excellent performance across the business and confirm our full-year guidance. Organic revenue increased by 7% driven by the consistent delivery of Fresenius Kabi and Fresenius Helios. This along with continued improvements in operations and lower interest costs led to an impressive EPS growth of 12%. Following the reduction of our stake in Fresenius Medical Care, a first and pivotal milestone in our history, we now start the Rejuvenate phase of #FutureFresenius from an even stronger position; this step underscores our commitment to creating long-term value. With a strengthened balance sheet and capital allocation priorities to further invest in our growth platforms, while also increasing our US presence, Fresenius is well positioned to deliver future profitable growth and innovation.” Outlook confirmed for Fiscal Year 2025 1 Fresenius Group 2 : organic revenue growth 3 of 4% to 6%, constant currency EBIT growth 4 in the range of 3% to 7% Fresenius Kabi 5 : organic revenue growth 3 in the mid- to high-single-digit percentage range; EBIT margin of 16.0% to 16.5% Fresenius Helios 6 : organic revenue growth in the mid-single-digit percentage range; EBIT margin around 10% Assumptions to guidance : When Fresenius gave guidance in February, the company acknowledged the fast-moving macro-economic and geopolitical environment, resulting in a higher level of operational uncertainty. Fresenius’ guidance continues to reflect current factors and known uncertainties such as potential impacts from tariffs to the extend they can currently be assessed. The guidance does not take into account potential extreme scenarios that could affect the company, its peers, and the healthcare sector as a whole. 1 Before special items 2 2024 base: €21,526 million (revenue) and €2,489 million (EBIT) 3 Organic growth rate adjusted for accounting effects related to Argentina hyperinflation. 4 Growth rate adjusted for Argentina hyperinflation 5 2024 base: €8,414 million (revenue) and €1,319 million (EBIT) 6 2024 base: €12,739 million (revenue) and €1,288 million (EBIT) Fresenius Group – Business development Q1/25 Fresenius entered with excellent momentum into the year with strong organic growth above the top-end of the 2025 guidance . The consistent positive delivery of Fresenius Kabi and the strong performance at Fresenius Helios drove a 7% 1 Group organic revenue 2 i ncrease to €5.63 billion. Due to a continued strong operating performance, Group EBIT before special items increased 4% 3 in constant currency to €654 million despite the high prior-year quarter which included energy relief fundings at Helios Germany. Particularly, a strong performance at Kabi and Helios in Spain contributed to the EBIT growth . The Helios Performance Programme delivers some first contributions with more significant contributions expected in the second half of the year. Earnings per share 2,4 rose by an excellent 12% 3 in constant currency to €0.74, driven by a broad-based operational strength and improved interest costs against the backdrop of a strong cash flow development and successful deleveraging. In Q1/25, Fresenius reached a pivotal milestone in #FutureFresenius with the reduction of participation in Fresenius Medical Care and the issuance of an exchangeable bond with Fresenius Medical Care shares underlying . These transactions underline Fresenius' clear commitment to long-term value creation and were the first visible signs of the Rejuvenate phase , which will focus on three key aspects in the coming years: Upgrade Core: Fresenius will continue to strengthen its core businesses. This includes, for example, reinforcing R&D pipelines, further increasing financial strength, and enhancing corporate culture. Scale Platforms: By strategically scaling its (Bio)Pharma, MedTech, and Care Provision platforms, Fresenius can make an important contribution to meeting the challenges facing healthcare systems around the world. The priorities are: Driving innovation at (Bio-)Pharma Expand MedTech to provide and connect technology solutions for critical clinical areas such as emergency rooms, operating rooms and intensive care units. Accelerate digitization of care provision Elevate Performance: Overall, Rejuvenate is designed to help the company achieve higher levels of performance and make Fresenius even more innovative and relevant. 1 Organic growth rate adjusted for accounting effects related to Argentina hyperinflation 2 Before special items 3 Growth rate adjusted for Argentina hyperinflation 4 Excluding Fresenius Medical Care Operating Companies – Business development Q1/25 Fresenius Kabi delivered a strong start to the year, Biopharma moving close to structural EBIT margin band Organic revenue growth of 6% 1 clearly driven by the Growth vectors; revenue increased by 5% to €2,146 million; positive Argentina pricing effects continued but less pronounced. Growth vectors with strong organic revenue 1 increase of 11%: MedTech 7%, Nutrition 7%, Biopharma 40%. Nutrition revenue: €612 million, benefited from positive pricing effects in Argentina and the good development in Europe; in the U.S. ongoing successful roll-out of lipid emulsions. Biopharma revenue: €190 million, mainly driven by the growth of Tyenne in Europe and the U.S.; launch of Ustekinumab biosimilar Otulfi® in EU and the U.S.; denosumab biosimilars Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) approved by FDA. MedTech revenue: €399 million, driven by strong growth related to the Ivenix pump rollout in the U.S, and broad-based positive development across most regions. Pharma revenue: €946 million, flat organic revenue development 1 against a high prior-year base; positive pricing development in Europe was offset by a softer development in the U.S. and China. China business continued to be impacted by a general economic weakness, price declines in connection with tenders, and hospital budget controls. EBIT 2 of Fresenius Kabi with 16% 3 constant currency increase to €360 million, driven by the strong revenue development of the Growth vectors and ongoing improvements in the cost base. The EBIT-margin 2 was very strong at 16.8%, a 170 bps yoy expansion. EBIT 2 of the Growth Vectors increased 45% 3 in constant currency to €184 million against the backdrop of a broad-based positive development; EBIT margin 2 at 15.3% increased by 390 bps year-on-year, Biopharma moving close to structural EBIT margin band. 1 Organic growth rate adjusted for accounting effects related to Argentina hyperinflation 2 Before special items 3 Growth rate adjusted for Argentina hyperinflation EBIT 1 of Pharma increased 5% 2 in constant currency to €216 million. EBIT margin 1 was strong at 22.9% driven in particular by ongoing cost savings and a strong pricing development in Europe. Fresenius Helios with excellent organic revenue growth; Helios Performance Programme evolving in-line with expectations. Very strong 8% organic revenue growth clearly above the structural growth band driven equally by Helios Germany (8% organic growth) and Helios Spain (8% organic growth); From a year-on-year perspective, Q1 also benefitted from the Easter effect falling in the second quarter this year; revenue before special items increased by 8% to €3,394 million. Helios Germany with revenue of €2,046 million; growth mainly driven by price effects: positive development of admissions and case mix. Helios Spain with revenue of €1,348 million, driven by strong activity levels and favourable price effects. The clinics in Latin America also showed a good performance. EBIT 1 of Fresenius Helios declined 4% to €333 million as the support from energy relief funds phased out by the end of Q3/24. This expected softness was partially compensated by excellent profitability at Helios Spain. EBIT margin 1 was solid at 9.8% driven by Helios Spain with a margin of 13.1% and 23% EBIT growth. EBIT 1 of Helios Germany decreased by 23% to €157 million against the high prior-year base which included energy relief funds; EBIT margin at 7.7% improved by 110 bps sequentially (Q4/24: 6.6%). Helios performance programme delivers some first contributions; ramp-up in H2/25 with more significant EBIT contributions, as some of the levers are process-related and will take time to deliver and realize benefits. 1 Before special items 2 Growth rate adjusted for Argentina hyperinflation Note on the presentation of financial figures If no timeframe is specified, information refers to Q1/2024. Consolidated results for Q1/25 as well as for Q1/24 include special items. An overview of the results for Q1/2025 - before and after special items – is available on our website. Growth rates in constant currency of Fresenius Kabi are adjusted. Adjustments relate to the hyperinflation in Argentina. Accordingly, in constant currency growth rates of the Fresenius Group are also adjusted. The results of Fresenius Helios and accordingly of the Fresenius Group for Q1/24 are adjusted by the sale of the fertility services group Eugin and the divestment of the majority stake in the hospital Clínica Ricardo Palma hospital in Lima, Peru. Information on the performance indicators is available on our website at www.fresenius.com/alternative-performance-measures . * * * Conference call and Audio webcast As part of the publication First Quarter 2025 results, a conference call will be held on May 7, 2025 at 1:30 p.m. CET (7:30 a.m. EST). All investors are cordially invited to follow the conference call in a live audio webcast at www.fresenius.com/investors . Following the call, a replay will be available on our website.

Drug ApprovalFinancial StatementBiosimilar

28 Apr 2025

·www.businesswire.com

CMS Grants Fresenius Kabi Permanent, Product-Specific Q-Code for Otulfi ® (ustekinumab-aauz)

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi, an operating company of Fresenius, announced today that the Centers for Medicare and Medicaid Services (CMS) issued a permanent, product-specific billing code for Otulfi® (ustekinumab-aauz). Under the Healthcare Common Procedure Coding System (HCPCS), the Q-code Q9999 is for “Injection, for subcutaneous use or intravenous use, ustekinumab-aauz (Otulfi), biosimilar per 1.0 mg.” Otulfi (ustekinumab-aauz) is FDA-approved for subcutaneous and intravenous formulations to treat the same conditions as the reference product Stelara® (ustekinumab), including Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. “This designation is an important milestone for broadening use of this biosimilar that supports quality patient care while reducing costs,” said Molly Benson, Senior Vice President, U.S. Biopharma at Fresenius Kabi. “As a recent addition to Fresenius Kabi’s biosimilar product offerings in the U.S., Otulfi is a key part of our company’s commitment to advancing biopharma to deliver enhanced care options.” The drug received FDA approval in September 2024 and was launched in the U.S. in March 2025. Developed by Formycon AG, a leading independent developer of biosimilars, this ustekinumab biosimilar is part of a global commercialization partnership that began in February 2023 between Formycon and Fresenius and covers key global markets. A Q-code is a CMS reimbursement code used by healthcare providers and payers to process claims for drugs administered through injection, infusion or other means. Commercial insurers and government payers use them to standardize claims submissions and reimbursements. Pass-through payments are used by hospital outpatient department services through the Hospital Outpatient Prospective Payment System (OPPS) to support use of new devices, drugs, and biologicals that meet eligibility criteria for a period of at least two years but not more than three years. To learn more about how Fresenius Kabi provides patient support, please visit the KABICARE™ patient services hub. 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 (ustekinumab-aauz) demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Stelara® in patients with moderate to severe plaque psoriasis. Otulfi (ustekinumab-aauz) 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 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 (ustekinumab-aauz) 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. IMPORTANT SAFETY INFORMATION Otulfi (ustekinumab-aauz) is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in Otulfi (ustekinumab-aauz). Infections Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products. Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following: Plaque psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, urinary tract infections. Psoriatic arthritis: cholecystitis. Crohn’s disease: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, Listeria meningitis Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, listeriosis. Avoid initiating treatment with Otulfi(ustekinumab-aauz) in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of Otulfi (ustekinumab-aauz) in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with Otulfi (ustekinumab-aauz). Discontinue Otulfi (ustekinumab-aauz) for serious or clinically significant infections until the infection resolves or is adequately treated. Theoretical Risk for Vulnerability to Particular Infections Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), Salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections. Consider appropriate diagnostic testing (e.g., tissue culture, stool culture, as dictated by clinical circumstances). Pre-Treatment Evaluation of Tuberculosis (TB) Evaluate patients for TB prior to initiating treatment with Otulfi (ustekinumab-aauz). Avoid administering Otulfi (ustekinumab-aauz) to patients with active TB infection. Initiate treatment of latent TB before administering Otulfi (ustekinumab-aauz). Consider anti-TB therapy prior to initiation of Otulfi (ustekinumab-aauz) in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving Otulfi (ustekinumab-aauz) for signs and symptoms of active TB during and after treatment. Malignancies Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among subjects who received ustekinumab in clinical trials. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy. The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer (NMSC). Monitor all patients receiving Otulfi (ustekinumab-aauz) for the appearance of NMSC. Closely follow patients >60 years of age, those with a medical history of prolonged immunosuppressant therapy, and those with a history PUVA treatment. Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue Otulfi (ustekinumab-aauz). Posterior Reversible Encephalopathy Syndrome (PRES) Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis and Crohn’s disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after initiating ustekinumab products. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab. Monitor all patients treated with Otulfi (ustekinumab-aauz) for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue Otulfi (ustekinumab-aauz). Immunizations Prior to initiating therapy with Otulfi (ustekinumab-aauz), patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with OTULFIOTULFI (ustekinumab-aauz) should not receive live vaccines. Avoid administering BCG vaccines during treatment with Otulfi (ustekinumab-aauz), or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving Otulfi (ustekinumab-aauz) because of the potential risk for shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of Otulfi (ustekinumab-aauz) may not elicit an immune response sufficient to prevent disease. Noninfectious Pneumonia Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases, administration of corticosteroids. If diagnosis is confirmed, discontinue Otulfi (ustekinumab-aauz) and institute appropriate treatment. Most Common Adverse Reactions The most common adverse reactions (≥3%) seen in patients treated with Otulfi (ustekinumab-aauz) are: Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, fatigue; Crohn’s disease, induction: vomiting. Crohn’s disease, maintenance: nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis. Ulcerative colitis, induction: nasopharyngitis Ulcerative colitis, maintenance: nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, nausea. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn and Facebook. Otulfi® (ustekinumab-aauz) is a trademark of Fresenius Kabi Deutschland GmbH in selected countries. Stelara® is a registered trademark of Johnson & Johnson.

Drug ApprovalClinical Result

100 Deals associated with Ustekinumab-Aauz

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KEGG	Wiki	ATC	Drug Bank
-	-	L04AC05	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Psoriasis	Canada	Fresenius Kabi Canada Ltd.	01 Dec 2024
Arthritis, Psoriatic	European Union	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Arthritis, Psoriatic	European Union	Formycon AG	25 Sep 2024
Arthritis, Psoriatic	Iceland	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Arthritis, Psoriatic	Iceland	Formycon AG	25 Sep 2024
Arthritis, Psoriatic	Liechtenstein	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Arthritis, Psoriatic	Liechtenstein	Formycon AG	25 Sep 2024
Arthritis, Psoriatic	Norway	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Arthritis, Psoriatic	Norway	Formycon AG	25 Sep 2024
Crohn's disease, active moderate	European Union	Formycon AG	25 Sep 2024
Crohn's disease, active moderate	European Union	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Crohn's disease, active moderate	Iceland	Formycon AG	25 Sep 2024
Crohn's disease, active moderate	Iceland	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Crohn's disease, active moderate	Liechtenstein	Formycon AG	25 Sep 2024
Crohn's disease, active moderate	Liechtenstein	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Crohn's disease, active moderate	Norway	Formycon AG	25 Sep 2024
Crohn's disease, active moderate	Norway	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Crohn's disease, active severe	European Union	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Crohn's disease, active severe	European Union	Formycon AG	25 Sep 2024
Crohn's disease, active severe	Iceland	Formycon AG	25 Sep 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Immune System Diseases	Phase 1	-	Aristo Pharma GmbH	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed Manual	Not Applicable	-	491	FYB202	pbizwtbmki(dmnjnedlnl) = All 3 comparisons showed PK similarity, since the 90% confidence intervals of the respective geometric mean ratios for area under the concentration-time curve from time 0 to infinity and maximum serum concentration were contained within the acceptance interval of 80%-125%. qniommummn (tuksljbswv ) View more	Similar	19 Oct 2024
				EU-Ref
FDA_CDER Manual	Not Applicable	Colitis, Ulcerative	961	Placebo (Prior biologic failure)	gqdaczebwk(twjajhqccs) = auxgvltkyc ixfsewwtzn (nxyrtqqujr ) View more	Positive	27 Sep 2024
				Ustekinumab	gqdaczebwk(twjajhqccs) = gbdzbzdlfy ixfsewwtzn (nxyrtqqujr ) View more
FDA_CDER Manual	Not Applicable	Crohn Disease	1,368	Placebo (CD-1)	lmacgoheow(pwcfouqjmq) = csegolqkvy tmtwwfylcc (onbtmgwucp ) View more	Positive	27 Sep 2024
				Ustekinumab (CD-1)	lmacgoheow(pwcfouqjmq) = mizrtvxunl tmtwwfylcc (onbtmgwucp ) View more
FDA_CDER Manual	Not Applicable	Crohn Disease	388	Placebo (CD-3)	dzoqhzrkod(neeyuxzqyp) = ejheoormyb ocnqzgqzmk (uwoyubzzdo ) View more	Positive	27 Sep 2024
				Ustekinumab (CD-3)	dzoqhzrkod(neeyuxzqyp) = iwsnzixxrj ocnqzgqzmk (uwoyubzzdo ) View more
FDA_CDER Manual	Not Applicable	Plaque psoriasis	73	Placebo	pwffhldmfl(wgpxqwdhen) = qjunrfjwvy dilijljdep (jvzzdboqih ) View more	Positive	27 Sep 2024
				Ustekinumab	pwffhldmfl(wgpxqwdhen) = ppxhgibbvv dilijljdep (jvzzdboqih ) View more
FDA_CDER Manual	Not Applicable	Plaque psoriasis	1,996	Placebo (Ps STUDY 1)	rnaqxnyaxl(fqklxaslrk) = rslefrjanl grbdskltxs (sooodccddi ) View more	Positive	27 Sep 2024
				Ustekinumab 45 mg (Ps STUDY 1)	rnaqxnyaxl(fqklxaslrk) = tjojhkczyp grbdskltxs (sooodccddi ) View more
FDA_CDER Manual	Not Applicable	Arthritis, Psoriatic	927	Placebo (PsA STUDY 1)	bgtnnebjdm(sdxkpxjesq) = dlihoqdrdt sbhyrxhbqe (sgdrcenjrh ) View more	Positive	27 Sep 2024
				Ustekinumab 45 mg (PsA STUDY 1)	bgtnnebjdm(sdxkpxjesq) = eeujgsiyve sbhyrxhbqe (sgdrcenjrh ) View more

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