Samsung Bioepis To Present Clinical And Scientific Data For Oncology Biosimilars At ESMO Congress 2026

• Phase 1 interim study for SB27, a proposed biosimilar to Keytruda (pembrolizumab), demonstrates its pharmacokinetic bioequivalence, comparable efficacy and safety to reference pembrolizumab in resected stage II–IIIA non-small cell lung cancer (NSCLC)
• Scientific presentation for SB16, a biosimilar to Prolia / Xgeva (denosumab), highlights the totality-of-evidence framework supporting full indication extrapolation of SB16 to oncology indications

Samsung Bioepis Co., Ltd. today announced that it will present clinical and scientific data for its two oncology biosimilars—SB27, a proposed biosimilar to Keytrudaⁱ (pembrolizumab), and SB16ⁱⁱ, a biosimilar to Proliaⁱⁱⁱ/Xgeva^iv (denosumab)— at the European Society for Medical Oncology (ESMO) Congress 2026, to be held October 23-27 in Madrid, Spain.

The presentations feature two abstracts highlighting Samsung Bioepis’s growing oncology portfolio: interim clinical findings evaluating the pharmacokinetics (PK), efficacy, and safety of SB27 in patients with resected stage II–IIIA non-small cell lung cancer (NSCLC) and a comprehensive evaluation detailing the totality-of-evidence supporting the indication extrapolation of SB16 from postmenopausal osteoporosis (PMO) to oncological indications.

“We are pleased to present meaningful clinical and scientific evidence for our oncology biosimilars at ESMO Congress 2026,” said Donghoon Shin, Executive Vice President and Clinical Sciences Division Leader at Samsung Bioepis. “The interim Phase 1 data for SB27 reinforce our high analytical and clinical standards by demonstrating pharmacokinetic bioequivalence alongside comparable efficacy and safety to reference pembrolizumab. Concurrently, our presentation on SB16 demonstrates the scientific rigor of our totality-of-evidence approach, underscoring how indication extrapolation based on shared mechanisms of action can reliably expand patient access to essential bone-targeted cancer treatments.”

Key Data Presentations at ESMO Congress 2026:

About SB27
SB27 is Samsung Bioepis’s proposed biosimilar to Keytruda (pembrolizumab). 

Pembrolizumab is a humanized monoclonal IgG4 kappa antibody directed against the programmed cell death protein 1 (PD-1) receptor. By inhibiting the interaction between PD-1 and its ligands (PD-L1 and PD-L2), it reactivates tumor-specific cytotoxic T-lymphocytes to target cancer cells across multiple tumor types.^v 

The randomized, double-blind, three-arm, parallel-group, multicenter Phase 1 clinical trial evaluated the PK, efficacy, safety, and immunogenicity of SB27 compared with EU-sourced and US-sourced reference pembrolizumab. A total of 163 participants with completely resected stage II–IIIA NSCLC who had completed adjuvant platinum-based chemotherapy were randomized in a 1:1:1 ratio to receive 200 mg Q3W of SB27, EU-sourced pembrolizumab, or US-sourced pembrolizumab intravenously. The total study duration was approximately 59 weeks (including a 28-day screening period). 

The co-primary PK endpoints were area under the concentration-time curve from Day 1 to the Day 22 (AUCD1-D22) at Cycle 1 and Cycle 6. Equivalence was assessed by analysis of covariance with weight as a covariate, and was established when the 90% confidence intervals (CIs) for geometric least squares means (LSMeans) ratio were contained within the equivalence margin of 80% to 125%.

About SB16
SB16 is Samsung Bioepis’ biosimilar referencing Prolia / Xgeva (denosumab), a human monoclonal antibody targeting the Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL). In Europe, the European Commission (EC) has granted marketing authorization for OBODENCE™ (60mg pre-filled syringe), a biosimilar referencing Prolia (denosumab) and XBRYK™ (120mg vial), a biosimilar referencing Xgeva (denosumab), in February 2025. In Europe, the products also received marketing authorizations from the Medicines and Healthcare products Regulatory Agency (MHRA) and Swissmedic in March 2025.

About OBODENCE (denosumab) In The European Union
OBODENCE 60 mg solution for injection in pre-filled syringe is indicated for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.

Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures.

Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

OBODENCE EU Important Safety Information
The EU Summary of Product Characteristics for OBODENCE includes the following Special warning and Precautions: 

• Hypocalcaemia
• Renal impairment
• Skin infections
• Osteonecrosis of the jaw (ONJ)
• Osteonecrosis of the external auditory canal
• Atypical fractures of the femur
• Long-term antiresorptive treatment
• Concomitant treatment with other denosumab-containing medicinal products
• Hypercalcaemia in paediatric patients

These highlights do not include all the information needed to use OBODENCE safely and effectively. Refer to the Summary of Product Characteristics for OBODENCE’s full safety information.

About XBRYK (denosumab) In The European Union
XBRYK 120 mg solution for injection is indicated for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone. 

Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

XBRYK EU Important Safety Information
The EU Summary of Product Characteristics for XBRYK includes the following Special warning and Precautions: 

• Hypocalcaemia
• Renal impairment
• Osteonecrosis of the jaw (ONJ)
• Osteonecrosis of the external auditory canal
• Atypical fractures of the femur
• Hypercalcaemia following treatment discontinuation in patients with giant cell tumour of bone and in patients with growing skeletons

These highlights do not include all the information needed to use XBRYK safely and effectively. Refer to the Summary of Product Characteristics for XBRYK’s full safety information.

About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings (KRX: 0126Z0), Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology, and neurology. For more information, visit www.samsungbioepis.com.

ⁱ  Keytruda is a trademark of Merck Sharp & Dohme LLC.

ⁱⁱ SB16 is approved and commercialized under different brand names in different regions. 

ⁱⁱⁱ Prolia is a trademark of Amgen Inc.

^iv Xgeva is a trademark of Amgen Inc.

^v  European Medicines Agency. Keytruda (pembrolizumab) Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/keytruda. Accessed October 2026.