European Introduction of Denosumab Biosimilars Strengthens Fresenius Kabi’s Position in Affordable Oncology and Osteoporosis Care

(IN BRIEF) Fresenius Kabi has launched its denosumab biosimilars Conexxence® and Bomyntra® across Europe following European Commission approval in July 2025 for all indications of their reference medicines Prolia® and Xgeva®. The products target a range of conditions including osteoporosis, therapy-related bone loss, skeletal complications from metastatic cancer, and giant cell tumor of bone. The company highlights the launch as an important step toward improving access to cost-effective biologic therapies, emphasizing its unique position as the first biosimilar supplier in Europe to offer a pre-filled syringe for the oncology indication. The rollout builds on a global settlement with Amgen and marks the fifth and sixth biosimilars introduced by Fresenius Kabi in Europe. Both Conexxence® and Bomyntra® underwent comprehensive clinical and analytical evaluations confirming equivalence to their respective reference biologics. Their launch is supported by the international patient resource program KabiCare. Fresenius Kabi continues to expand its global role in biopharmaceuticals, clinical nutrition, and medical technologies as part of the broader Fresenius Group.

(PRESS RELEASE) BAD HOMBURG, 2-Dec-2025 — /EuropaWire/ — Fresenius Kabi, a key division of the global healthcare group Fresenius, has introduced its denosumab biosimilars Conexxence® and Bomyntra® to the European market. These launches follow European Commission authorization granted in July 2025, covering all approved uses of the reference biologics Prolia® and Xgeva®. Together, the products address a wide spectrum of clinical needs, ranging from osteoporosis in postmenopausal women and men at elevated risk of fractures to therapy-related bone loss, prevention of skeletal complications caused by bone metastases, and treatment of giant cell tumor of bone.

The company emphasized that this rollout represents an important advancement in improving patient access to high-quality biologic alternatives. Dr. Sang Jin Pak, President Biopharma at Fresenius Kabi, noted that being the first biosimilar manufacturer in Europe to offer a pre-filled syringe option for the oncology indication marks a meaningful step in their efforts to broaden affordable treatment choices for patients and healthcare systems across the region.

Earlier in the year, Fresenius Kabi finalized a global settlement with Amgen related to its denosumab biosimilar portfolio, clearing the pathway for commercialization. Conexxence® and Bomyntra® now become the fifth and sixth biosimilars the company has made available in Europe. Fresenius Kabi continues to invest heavily in its biosimilar pipeline, developing multiple molecules across early and late-stage programs focused on autoimmune diseases and oncology.

The introduction of the two medicines is supported by KabiCare, the company’s global patient and healthcare provider support platform. Through educational resources, treatment guidance, and practical tools for daily management, KabiCare helps ensure that patients and clinicians can use these biologics with confidence and clarity, contributing to more sustainable healthcare delivery across Europe.

About Conexxence

The active ingredient in Conexxence® is denosumab. Denosumab is a monoclonal antibody that inhibits RANKL, reducing bone resorption and increasing bone mass. Conexxence® is administered by subcutaneous injection.

The biosimilar development program for Conexxence® included analytical, non-clinical, and clinical studies confirming equivalent efficacy and comparable safety to Prolia®³, including a Phase 1 pharmacokinetic/ pharmacodynamic trial in healthy volunteers and a Phase 3 trial (LUMIADE-3)⁵.

Conexxence® is approved in the EU⁶ and other key markets such as the US⁷ and UK⁸ for the treatment of osteoporosis in postmenopausal women and men at increased risk of fracture, and for bone loss associated with hormone ablation in cancer patients.

About Bomyntra

The active ingredient in Bomyntra® is denosumab. Denosumab inhibits RANKL, reducing bone destruction associated with malignancy. Bomyntra® is administered by subcutaneous injection.

The biosimilar development program for Bomyntra® included analytical, non-clinical, and clinical studies confirming equivalent efficacy and comparable safety to Prolia®³, including a Phase 1 pharmacokinetic/ pharmacodynamic trial in healthy volunteers and a Phase 3 trial (LUMIADE-3)⁵.

Bomyntra® is approved in the EU⁹ and other key markets such as US¹⁰ and UK¹¹ for the prevention of skeletal-related events in adults with advanced malignancies involving bone and for the treatment of giant cell tumor of bone.

About KabiCare

KabiCare is Fresenius Kabi’s comprehensive patient support program, available to patients and HCPs across the world. The online resource provides patients with the knowledge to better understand their illness, gives information about their treatment and offers practical information for their daily life. For more information, please visit KabiCare.

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.

References

¹ Conexxence® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries.

² Bomyntra® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries.

³ Prolia® is a registered trademarks of Amgen Inc.

⁴ Xgeva® is a registered trademarks of Amgen Inc.

⁵ ClinicalTrials.gov. A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis. Available at: https://clinicaltrials.gov/search?term=NCT04934072 [Last accessed November 2025]

⁶ Conexxence (denosumab) EMA Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/conexxence [Last accessed November 2025]

⁷ Conexxence (denosumab) US prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761398Orig1s000lbl.pdf [Last accessed November 2025]

⁸ Conexxence (denosumab) Summary of product characteristics. Available at: https://mhraproducts4853.blob.core.windows.net/docs/6dd26621a11588a15513ca3428190f347abbc8b4. [Last accessed November 2025]

⁹ Bomyntra (denosumab) EMA Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/bomyntra [Last accessed November 2025]

¹⁰ Bomyntra (denosumab) US prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761398Orig1s000lbl.pdf [Last accessed November 2025]

¹¹ Bomyntra (denosumab) Summary of product characteristics. Available at: https://mhraproducts4853.blob.core.windows.net/docs/8579abb55e9f7900e69234038c408ede839901af and https://mhraproducts4853.blob.core.windows.net/docs/c7ffba83463e2ffee978af110368111e0761b531. [Last accessed November 2025]

Media Contact:

Katrin Kerner
Head of Group Communications
(Press and Media Relations)
T +49 (0) 6172 608 96273
pr-fre@fresenius.com

SOURCE: Fresenius Kabi AG

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