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

Clinical Research 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.

01 Nov 2011·mAbsQ2 · MEDICINE

Discovery and mechanism of ustekinumab

Q2 · MEDICINE

Review

Author: Jill M. Giles-Komar ; Jacqueline M. Benson ; David Peritt ; Mary Ann Mascelli ; George A. Heavner ; David J. Shealy ; Bernard J. Scallon

Monoclonal antibody (mAb) therapy was first established upon the approval of a mouse antibody for treatment of human acute organ rejection. However, the high incidence of immune response against the mouse mAb restricted therapeutic utility. Development of chimeric, "humanized" and human mAbs broadened therapeutic application to immune-mediated diseases requiring long-term treatment. Indeed, mAb therapeutics targeting soluble cytokines are highly effective in numerous immune-mediated disorders. A recent example is ustekinumab, a first-in-class therapeutic human immunoglobulin G1 kappa mAb that binds to the interleukins (IL)-12 and IL-23, cytokines that modulate lymphocyte function, including T-helper (Th) 1 and Th17 cell subsets. Ustekinumab was generated via recombinant human IL-12 immunization of human immunoglobulin (hu-Ig) transgenic mice. Ustekinumab binds to the p40 subunit common to IL-12 and IL-23 and prevents their interaction with the IL-12 receptor β1 subunit of the IL-12 and IL-23 receptor complexes. Ustekinumab is approved for treatment of moderate-to-severe plaque psoriasis and has demonstrated efficacy in Crohn disease and psoriatic arthritis. The clinical characterization of ustekinumab continues to clarify our understanding of human immune pathologies and may offer a novel therapeutic option for certain immune-mediated diseases.

News (Medical) associated with Ustekinumab-Aauz

01 Jul 2026

·www.prnewswire.com

New report: CivicaScript saved patients & payers more than $16 million in generic medicine costs in 2025

Nonprofit pharmaceutical company has delivered nearly $44 million in savings since 2022 LEHI, Utah, June 25, 2026 /PRNewswire/ -- CivicaScript's transparent, nonprofit business model saved patients and payer members more than $16 million in 2025 after they switched to its low-cost generic medicines, the company's new Annual Savings Report shows. Patients saved as much as 91% per claim. Since the launch of its first product in 2022, CivicaScript has delivered nearly $44 million in savings to patients and its payer members. The 2025 savings were driven by CivicaScript's first product, abiraterone acetate tablets USP, 250 mg, and four additional specialty generics launched that year. The new report shows that while conversion to CivicaScript's newer products is still in early stages, the products are already driving significant per claim savings. Meanwhile, the continued growth of CivicaScript abiraterone (now sold under the proprietary name Abirtega®) underscores the ongoing need for the company's unique business model. "CivicaScript was created to bring affordability and transparency to the generic and biosimilar drug market," said CivicaScript President Brent J. Eberle. "This report demonstrates the substantial savings that can be achieved when manufacturers, payers and pharmacies work together to put patients first." CivicaScript expects savings to continue to grow as additional products gain adoption and its new therapies enter the market. Earlier this year, the organization expanded into biosimilars with the launch of a low-cost private-label insulin glargine and exclusive distribution of ustekinumab-aauz,1 a biosimilar to Stelara®2. Civica insulin is available nationwide; in California, it is sold under the CalRx®3 brand. Key 2025 savings data Patients who used CivicaScript medicines in 2025 saved more than $400,000 in out-of-pocket pharmacy costs. Per claim savings varied by product and product strength; the highest average per claim savings for patients was $56 (for droxidopa capsules, 300 mg). CivicaScript payer members, who bear a larger share of total medicine costs, saw $15.7 million in savings in 2025. On average, payers saved $856/claim with abiraterone – the company's most utilized product -- and $80/claim to $2,358/claim for its four newer products. CivicaScript is a nonprofit pharmaceutical company created in 2020 to lower the prices of prohibitively expensive generic medicines. The company's business model is to manufacture low-cost generic medicines, then work with payers, PBMs and pharmacies across the country to pass along the cost savings to patients. The model focuses on transparency and collaboration throughout the value chain from manufacturing through dispensing — with every stakeholder along the way knowing the price of the medicine and driving savings through to the patient. CivicaScript's MaxRP® policy is its maximum recommended price to the consumer. Information on every CivicaScript product package enables healthcare providers, caregivers, patients and others to compare prices and confirm they are being charged no more than the MaxRP. "At a time when too many families are facing rising prescription drug costs, our partnership with CivicaScript is delivering on a simple, but powerful, promise to make essential generic medicines more affordable," said Sean Robbins, EVP and Chief Operating Officer at Blue Cross Blue Shield Association. "By advancing a transparent model that puts patients first, we're helping reshape the marketplace to bring more competition, lower costs and improve access for the people who need these medicines most." About the analysis The report analyzed pharmacy claims data from January 1 through December 31, 2025, from each CivicaScript member. The report reflects the savings from CivicaScript products as of their first full quarter of availability. 1 Ustekinumab-aauz injection, 45 mg/0.5mL and 90 mg/mL 2 Stelara® is a registered trademark of Johnson & Johnson. 3 CalRx® is a registered trademark of the California Department of Health Care Access and Information. SOURCE Civica Rx 21% more press release views with Request a Demo

06 Jan 2026

·www.biospace.com

Fresenius Kabi Introduces New Presentation of Otulfi® (ustekinumab-aauz), a Biosimilar to Stelara®

45 mg/0.5 mL single dose vial provides dosing flexibility for pediatric patients LAKE ZURICH, Ill.--(BUSINESS WIRE)-- #CommittedToLife --Fresenius Kabi, an Operating Company of Fresenius, and a leading provider of essential medicines and medical technologies, announced today it has introduced a new presentation of Otulfi ® (ustekinumab-aauz) in a 45 mg/0.5 mL single-dose vial for subcutaneous injection. Otulfi ® is a prescription medicine and the brand name for Fresenius Kabi’s FDA-approved biosimilar of the reference product, Stelara ® (ustekinumab). With this addition, Fresenius Kabi now offers all dosage forms and strengths of the reference product, giving physicians flexibility and supporting patient treatment continuity. Fresenius Kabi’s Otulfi ® has also received interchangeability designation from the FDA. Otulfi ® was approved by the U.S. Food and Drug Administration in September 2024 for the treatment of adults with moderately to severely active Crohn’s disease and ulcerative colitis, and adults and pediatric patents ages 6 and older with moderate to severe plaque psoriasis (who are candidates for phototherapy or systemic therapy) and active psoriatic arthritis. The new dosage form provides dosing flexibility for pediatric patients under 60kg (132 lbs) who have plaque psoriasis and psoriatic arthritis. In March, Fresenius Kabi introduced Otulfi ® in 45 mg/0.5mL and 90mg/mL single-dose prefilled syringes for subcutaneous injection and a 130mg/26mL single-dose vial for intravenous infusion. “With this new presentation of Otulfi, we’re expanding treatment options for pediatric patients and reinforcing our commitment to improving access to biosimilars. Fresenius Kabi continues to grow its biosimilar portfolio to ensure patients of all ages benefit from therapies that meet the FDA’s rigorous standards for safety and efficacy," said Dr. Sang-Jin Pak, President Biopharma, Fresenius Kabi. In May 2025, the 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 1 . This can lead to a reduced administrative burden. Not all biosimilars receive interchangeability status. About Otulfi ® (ustekinumab-aauz) Otulfi ® (ustekinumab-aauz) is indicated for the treatment of moderately to severely active Crohn’s disease and ulcerative colitis in adult patients; moderate to severe 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. Otulfi ® is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in Otulfi ® . The drug received FDA approval in September 2024 and has been available in the U.S. since March 2025. Otulfi ® 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 ® 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. 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 . Please click to see the full Prescribing Information and Medication Guide for Otulfi ® (ustekinumab-aauz) here . About Fresenius Kabi As a global healthcare 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 essential 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. 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. 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 healthcare. Fresenius Kabi is part 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 healthcare solutions on a global scale. For more information, please visit . To learn about U.S. career opportunities at Fresenius Kabi, visit us at and follow us on LinkedIn and Facebook . Reference: U.S. Food and Drug Administration. (2024, June 20). 9 Things to Know About Biosimilars and Interchangeable Biosimilars . 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. Otulfi ® (ustekinumab-aauz) is a trademark of Fresenius Kabi Deutschland GmbH in selected countries. Stelara ® is a registered trademark of Johnson & Johnson. Contacts Media contact Joanie Clougherty (614) 717-5741 Joan.Clougherty@fresenius-kabi.com

Drug ApprovalBreakthrough Therapy

05 Jan 2026

·www.prnewswire.com

CivicaScript announces availability of low-cost insulin and biosimilar for chronic inflammatory conditions in the US

New additions expand company's rapidly growing product portfolio LEHI, Utah, Jan. 5, 2026 /PRNewswire/ -- CivicaScript®, LLC, a nonprofit company dedicated to bringing low-cost generic medicines and biosimilars to U.S. patients, today announced the availability of two new products: insulin glargine-yfgn and ustekinumab-aauz. Civica insulin glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus, and is interchangeable1 with Lantus®2 (insulin glargine). It is the result of a collaborative effort of Civica, CivicaScript, the Civica Foundation and other partners to improve the availability of affordable insulin. Civica insulin glargine-yfgn is marketed nationally by CivicaScript. Thanks to a partnership with the state of California's CalRx® program, it will carry the CalRx brand in California pharmacies. Ustekinumab-aauz is indicated for the treatment of chronic inflammatory conditions in certain patients with plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. It is interchangeable3 to the reference product Stelara®4 (ustekinumab). "We're proud to begin the New Year by expanding access to two important biosimilars that can help lower costs for patients and health plans," said CivicaScript President Brent J. Eberle. "Our growing portfolio shows that putting patients first isn't just the right thing to do – it's a proven path to delivering affordable generics and biosimilars." Civica insulin glargine-yfgn is available in prefilled pens at the lowest list price in the current long-acting insulin market. CivicaScript is selling it to pharmacies across the United States for $45 for a box of five pens – a significant discount in many cases to current prices. CivicaScript's maximum recommended price (MaxRPTM policy) for consumers is no more than $55. The cost to consumers may be even lower than $55, depending on a person's insurance plan. This stable, transparent price contrasts with copay assistance programs offered by other manufacturers, which require patients to register for programs that can change at any time. CivicaScript sells ustekinumab-aauz in pre-filled syringes for subcutaneous injection in two strengths. The Wholesale Acquisition Cost for a 12-week supply of 90 mg is $985 and the WAC for a 12-week supply of 45 mg is $575. The biosimilar is available at this low, transparent price to CivicaScript's members and partners, including health plans and pharmacy benefit managers. 1 See Prescribing Information. 2 Lantus® is a registered trademark of sanofi-aventis U.S. LLC. 3 See Prescribing Information. 4 Stelara® is a registered trademark of Johnson & Johnson. About CivicaScript CivicaScript is bringing unprecedented transparency to the drug supply chain to make quality generic medicines affordable and available for everyone. A not-for-profit company, CivicaScript is committed to providing affordable, essential generic medicines and biosimilars to promote the social welfare and health of the community. For more information on the organization and our mission, visit our website. CivicaScript is the Civica, Inc. operating unit for outpatient medications. About insulin glargine-yfgn Do not dilute or mix insulin glargine-yfgn with any other insulin or solution. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner. Do not administer insulin glargine-yfgn via an insulin pump or intravenously because hypoglycemia can occur. For full prescribing information and patient information, including warnings and precautions, potential adverse reactions and drug interactions, please see Prescribing Information. About ustekinumab-aauz Indications: 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; and moderately to severely active ulcerative colitis. Ustekinumab-aauz also is indicated for pediatric patients ≥6 years of age with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and for pediatric patients ≥6 years of age with active psoriatic arthritis. Contraindications: Ustekinumab-aauz is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in ustekinumab-aauz. For more information, please see Prescribing Information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Media Contact Liz Power, Vice President, Communications [email protected] 860 501 3849 SOURCE CivicaScript 21% more press release views with Request a Demo

AcquisitionDrug Approval

100 Deals associated with Ustekinumab-Aauz

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Colitis, Ulcerative	United Kingdom	Fresenius Kabi Ltd.	20 Dec 2024
Crohn Disease	United Kingdom	Fresenius Kabi Ltd.	20 Dec 2024
Psoriasis	Canada	Fresenius Kabi Canada Ltd.	01 Dec 2024
Arthritis, Psoriatic	European Union	Formycon AG	25 Sep 2024
Arthritis, Psoriatic	European Union	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Arthritis, Psoriatic	Iceland	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Arthritis, Psoriatic	Iceland	Formycon AG	25 Sep 2024
Arthritis, Psoriatic	Liechtenstein	Formycon AG	25 Sep 2024
Arthritis, Psoriatic	Liechtenstein	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Arthritis, Psoriatic	Norway	Formycon AG	25 Sep 2024
Arthritis, Psoriatic	Norway	Fresenius Kabi Deutschland GmbH	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	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Crohn's disease, active moderate	Liechtenstein	Formycon AG	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	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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed Manual	Not Applicable	-	491	FYB202	egfldreghs(irysdwdkdl) = 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%. ruzaigvtgv (rqvyrmpwkk ) View more	Similar	19 Oct 2024
				EU-Ref
FDA_CDER Manual	Not Applicable	Crohn Disease	1,368	Placebo (CD-1)	ioegdjntji(kignebwfze) = cxcsoeavof ylhbksxvos (hzzinwykal ) View more	Positive	27 Sep 2024
				Ustekinumab (CD-1)	ioegdjntji(kignebwfze) = mnvcekixgp ylhbksxvos (hzzinwykal ) View more
FDA_CDER Manual	Not Applicable	Arthritis, Psoriatic	927	Placebo (PsA STUDY 1)	govoogzgsk(agyelbllls) = gfjcfroptk wbukkuwumq (ojhygbknvs ) View more	Positive	27 Sep 2024
				Ustekinumab 45 mg (PsA STUDY 1)	govoogzgsk(agyelbllls) = taahdkbwyh wbukkuwumq (ojhygbknvs ) View more
FDA_CDER Manual	Not Applicable	Crohn Disease	388	Placebo (CD-3)	arehbbstsk(jgsrknabhg) = gaqqrkmfkp yqisutmrmw (kwoewuslec ) View more	Positive	27 Sep 2024
				Ustekinumab (CD-3)	arehbbstsk(jgsrknabhg) = xsfpdaypji yqisutmrmw (kwoewuslec ) View more
FDA_CDER Manual	Not Applicable	Plaque psoriasis	73	Placebo	eyorvhbpln(cotzquysoo) = axbkqiikcj exskrzaqor (iokutvifcz ) View more	Positive	27 Sep 2024
				Ustekinumab	eyorvhbpln(cotzquysoo) = wesfdwwzni exskrzaqor (iokutvifcz ) View more
FDA_CDER Manual	Not Applicable	Colitis, Ulcerative	961	Placebo (Prior biologic failure)	nzpjzgwfvm(ggulyqkvmm) = oyyjwogcyy ksrrnjnyfq (yzvppinojc ) View more	Positive	27 Sep 2024
				Ustekinumab	nzpjzgwfvm(ggulyqkvmm) = rpyrojhphv ksrrnjnyfq (yzvppinojc ) View more
FDA_CDER Manual	Not Applicable	Plaque psoriasis	1,996	Placebo (Ps STUDY 1)	tkdqsbvxvy(gdmvjengja) = edjmjroqef vmmzfmkcoo (fykalbtief ) View more	Positive	27 Sep 2024
				UstekinumabUstekinumab 45 mg (Ps STUDY 1)	tkdqsbvxvy(gdmvjengja) = vupeolgwaz vmmzfmkcoo (fykalbtief ) View more

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