CMS Grants Fresenius Kabi Permanent, Product-Specific Q-Code for Conexxence® and Bomyntra® (denosumab-bnht)

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LAKE ZURICH, Ill.--(BUSINESS WIRE)--Sep 29, 2025--

Fresenius Kabi, a part of the global healthcare company of Fresenius, announced today that the Centers for Medicare and Medicaid Services (CMS) issued a permanent, product-specific billing code for Conexxence ®(1) and Bomyntra ®(2) (denosumab-bnht).

Under the Healthcare Common Procedure Coding System (HCPCS), the Level II codeQ5158, is for “Injection, denosumab-bnht (bomyntra/conexxence), biosimilar, 1 mg effective October 1, 2025.”

These denosumab biosimilars were approved by the FDA for all indications of the reference products, Prolia ®(3) (denosumab) and Xgeva ®(4) (denosumab), respectively.

“This designation helps broaden access to these high-quality biological medicines which support quality patient care while reducing costs,” said Dr. Sang Jin Pak, President Fresenius Kabi Biopharma. “As our biosimilar portfolio continues to expand, we will be able to provide access for even more patients.”

The drugs received FDA approval in March 2025 and were launched in the U.S. on July 1, 2025. Earlier this year, Fresenius announced Fresenius Kabi reached a global settlement with Amgen concerning its denosumab biosimilars.

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.

Conexxence and Bomyntra (denosumab-bnht) are the fifth and sixth Fresenius biosimilar commercialized in the U.S., following the approvals and launches of adalimumab-aacf, Tyenne ® (tocilizumab-aazg), Stimufend ® (pegfilgrastim-fpgk), and Otulfi ® (ustekinumab-aauz). Fresenius’s growing pipeline of autoimmune and oncology biosimilars also has several molecules in early and late-stage development.

About Conexxence ®(1) (denosumab-bnht) and Bomyntra ®(2) (denosumab-bnht)

Conexxence ®(1) (denosumab-bnht) is approved for use in various adult patient populations at high risk for fractures, including individuals with osteoporosis, patients undergoing certain cancer treatments that affect bone density, and patients receiving long-term glucocorticoid therapy. In the U.S., Conexxence ®(1) carries a boxed warning and includes a Risk Evaluation and Mitigation Strategy (REMS) program, which aims to educate prescribers and patients about the risk of severe hypocalcemia in patients with advanced chronic kidney disease, including those on dialysis. Conexxence® is contraindicated in patients with hypocalcemia, during pregnancy and in cases of known hypersensitivity to denosumab products.

Bomyntra ®(2) (denosumab-bnht) is approved for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. It is also indicated for the treatment of hypercalcemia of malignancy that is refractory to bisphosphonate therapy and the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Bomyntra ®(2) (denosumab-bnht) is contraindicated in patients with hypocalcemia and those with known hypersensitivity to denosumab products.

Patients receiving Conexxence ® or Bomyntra ® should not receive other denosumab products concomitantly. If a clinically significant allergic reaction occurs with Conexxence ® or Bomyntra ®, treatment should be permanently discontinued.

For Conexxence ® full Prescribing Information, including boxed warning, please visit https://biosimilars.fresenius-kabi.com/portfolio/products/conexxence. For details on the Conexxence® REMS program, visit: https://www.conexxencerems.com /

For Bomyntra ® full Prescribing Information, please visit https://biosimilars.fresenius-kabi.com/portfolio/products/bomyntra/dosing-administration

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 critically and chronically ill patients. With more than 41,000 employees and present in over 130 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. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare 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 healthcare 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 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 healthcare solutions on a global scale.

For more information, please visit www.fresenius-kabi.com.

(1)(2) Conexxence ® and Bomyntra ® are registered trademarks of Fresenius Kabi Deutschland GmbH in selected countries.

(3)(4) Prolia ® and Xgeva ® are registered trademarks of Amgen Inc.

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SOURCE: Fresenius Kabi

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PUB: 09/29/2025 11:00 AM/DISC: 09/29/2025 10:59 AM

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