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

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250428100791/en/