Samsung Bioepis Launches Denosumab Biosimilars OBODENCE™ and XBRYK™ in Europe to Improve Access and Patient Outcomes
Samsung Bioepis Co., Ltd., a global biopharmaceutical company recognized for its innovative work in developing biosimilars across multiple therapeutic areas, today announced the commercial launch of two new denosumab biosimilars in Europe: OBODENCE™ (60 mg pre-filled syringe) and XBRYK™ (120 mg vial). These biosimilars reference the well-established originator products Prolia® and Xgeva®, respectively. OBODENCE™ will be available across European markets starting December 2025, followed by XBRYK™ in January 2026.
The introduction of OBODENCE™ and XBRYK™ reflects Samsung Bioepis’ ongoing commitment to enhancing patient access to high-quality, cost-effective treatment options. Denosumab, a monoclonal antibody targeting RANKL (receptor activator of nuclear factor kappa-B ligand), is a critical therapy in the management of bone-related conditions including osteoporosis and skeletal complications associated with cancer metastases. By providing biosimilar alternatives, Samsung Bioepis aims to address both the clinical and economic challenges faced by healthcare systems and patients across Europe.
Expanding Access to Bone Health Treatments
“We are extremely excited to launch OBODENCE™ and XBRYK™ through our direct sales channels in Europe,” said Linda Choi MacDonald, Executive Vice President and Global Head of the Commercial Division at Samsung Bioepis. “Osteoporosis remains a significant public health challenge across the continent, with many patients lacking access to timely and affordable treatments. Similarly, bone complications arising from metastatic cancers can drastically reduce a patient’s quality of life and even increase mortality if not addressed promptly. Our biosimilars are designed to improve accessibility, enable timely care, and reduce financial burdens on healthcare systems, while maintaining the high-quality standards expected from Samsung Bioepis.”
OBODENCE™ and XBRYK™ not only expand the therapeutic options available in Europe but also align with global efforts to improve patient outcomes by introducing more affordable biosimilar alternatives. By doing so, Samsung Bioepis reinforces its position as a leader in delivering high-value biologics that address unmet medical needs across multiple therapeutic areas.
OBODENCE™: Addressing Osteoporosis and Bone Loss
OBODENCE™ is a biosimilar to Prolia® and is indicated for several conditions related to bone fragility. In the European Union, OBODENCE™ 60 mg pre-filled syringe is approved for:
- Treatment of osteoporosis in postmenopausal women and men at increased risk of fractures: Denosumab has been shown to significantly reduce the risk of vertebral, non-vertebral, and hip fractures, which are associated with substantial morbidity, reduced mobility, and increased mortality.
- Treatment of bone loss in men undergoing hormone ablation therapy for prostate cancer: Hormone ablation can accelerate bone loss, placing patients at higher risk for vertebral fractures. Denosumab effectively reduces this risk, supporting skeletal health during cancer treatment.
- Management of glucocorticoid-induced bone loss in adults: Long-term systemic glucocorticoid therapy, often used to treat autoimmune or inflammatory conditions, is associated with increased fracture risk. OBODENCE™ offers a therapeutic option to mitigate this complication and protect bone integrity.
Osteoporosis remains a critical public health issue in Europe, affecting millions of individuals and imposing a substantial economic burden. It is estimated that osteoporosis results in approximately 4.3 million fragility fractures annually, with associated healthcare costs exceeding €56 billion. Despite the availability of effective treatments, less than half of women at high risk of fractures receive appropriate therapy, often due to cost barriers or limited access. By providing OBODENCE™ as a biosimilar option, Samsung Bioepis aims to enhance treatment accessibility and reduce the financial burden on patients and healthcare systems.
XBRYK™: Supporting Patients with Bone-Related Complications from Cancer
XBRYK™ is a biosimilar referencing Xgeva®, a therapy widely used in oncology to prevent skeletal-related events (SREs) in patients with bone metastases or certain bone tumors. XBRYK™ 120 mg vials are indicated in the European Union for:
- Prevention of skeletal-related events in adults with advanced malignancies involving bone: SREs include pathological fractures, spinal cord compression, radiation to bone, and surgical interventions. These events not only cause severe pain and impair quality of life but also increase mortality and healthcare costs.
- Treatment of unresectable or surgically challenging giant cell tumor of bone in adults and skeletally mature adolescents: Giant cell tumors can cause substantial morbidity if untreated or in cases where surgery would lead to severe complications. XBRYK™ provides an effective non-surgical therapeutic alternative.
Bone metastases are a common complication of cancers such as breast, prostate, and lung cancer. Patients affected by skeletal complications often experience debilitating pain, reduced mobility, and a higher risk of mortality. By launching XBRYK™, Samsung Bioepis seeks to provide patients with timely access to an essential therapy that mitigates these complications and enhances overall quality of life.
Biosimilar Innovation and Samsung Bioepis’ Growing Portfolio
OBODENCE™ represents Samsung Bioepis’ first biosimilar in endocrinology, while XBRYK™ is the company’s third biosimilar in oncology. Together, they mark the 10th and 11th biosimilars launched by Samsung Bioepis in Europe, underscoring the company’s extensive commitment to developing high-quality, accessible biologics across multiple therapeutic domains. The company’s broader portfolio includes therapies in immunology, oncology, ophthalmology, hematology, and nephrology, reflecting a diversified approach to addressing global healthcare needs.
Samsung Bioepis leverages state-of-the-art manufacturing processes and rigorous clinical evaluation to ensure that its biosimilars meet the highest standards of safety, efficacy, and quality. By doing so, the company not only provides more affordable alternatives to originator biologics but also supports the sustainability of healthcare systems across Europe and beyond.
OBODENCE™ EU Important Safety Information
As with all medications, OBODENCE™ carries specific safety considerations that healthcare providers should consider when prescribing. The European Union Summary of Product Characteristics (SmPC) highlights the following precautions and warnings:
- Hypersensitivity: Serious allergic reactions may occur; patients should be monitored for signs of an allergic response.
- Hypocalcemia: Denosumab may cause low blood calcium levels; supplementation with calcium and vitamin D is recommended where appropriate.
- Renal impairment: Special caution is advised in patients with compromised kidney function.
- Skin infections: Certain infections may be more likely during treatment.
- Osteonecrosis of the jaw (ONJ) and external auditory canal: Rare but serious adverse effects associated with prolonged antiresorptive therapy.
- Atypical femoral fractures: Long-term therapy may be linked to unusual fracture patterns.
- Concomitant use of other denosumab-containing products: Not recommended due to potential additive effects.
- Hypercalcemia in pediatric patients: Denosumab is generally not indicated in this population; monitoring is advised in specific cases.
These highlights are not exhaustive; healthcare providers should refer to the full SmPC for OBODENCE™ to ensure safe and effective use.
Commitment to Patient-Centric Care
The launch of OBODENCE™ and XBRYK™ demonstrates Samsung Bioepis’ commitment to patient-centric care by expanding access to critical therapies for bone health. Osteoporosis and cancer-related bone complications are associated with high morbidity and substantial healthcare costs. By providing biosimilar alternatives, Samsung Bioepis enables broader access to effective treatments, reduces financial burdens, and supports healthcare providers in delivering timely and efficient care.
The company’s direct-to-market approach for these biosimilars reflects a strategic effort to strengthen engagement with healthcare professionals, ensure supply reliability, and facilitate patient access across European markets. Samsung Bioepis’ focus on high-quality biosimilars aligns with global initiatives to promote cost-effective healthcare solutions without compromising clinical outcomes.
About Samsung Bioepis
Samsung Bioepis is a global biopharmaceutical company specializing in the development, manufacture, and commercialization of biosimilars across multiple therapeutic areas. With a focus on innovation, quality, and patient access, Samsung Bioepis has established itself as a trusted provider of biosimilar medicines worldwide. The company’s portfolio spans endocrinology, oncology, immunology, ophthalmology, hematology, and nephrology, reflecting its commitment to addressing unmet medical needs and enhancing healthcare sustainability.
Through strategic partnerships, rigorous clinical development, and advanced manufacturing capabilities, Samsung Bioepis continues to expand the availability of biosimilars to patients in need, reinforcing its mission to improve healthcare access and outcomes globally.
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