FDA Approves Samsung Bioepis’ OSPOMYV™, XBRYK™ (denosumab-dssb), a Biosimilar to Prolia and Xgeva

• OSPOMYV™ and XBRYK™ approved by the U.S. Food and Drug Administration (FDA) for all indications referencing Prolia and Xgeva, respectively
• Samsung Bioepis’ first endocrinology biosimilar to be approved by the FDA – widening its therapeutic areas and portfolios

Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for OSPOMYV™ (denosumab-dssb; SB16; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; SB16; 120 mg vial), biosimilars referencing Prolia and Xgeva respectively. In addition, the FDA granted a provisional determination for both Ospomyv and Xbryk's interchangeability designation.

OSPOMYV, referencing Prolia, has been approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture, treatment to increase bone mass in men with osteoporosis at high risk for fracture, treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer and for the treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

XBRYK, referencing Xgeva, has been approved for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, 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, and for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

“The FDA approval of OSPOMYV and XBRYK marks a key step in improving patient access and alleviating treatment cost for patients with osteoporosis and cancer-related bone loss in the US. By providing quality-proven biosimilars, we are helping to address a critical healthcare need and reduce the burden of skeletal fractures that impact patients’ quality of life,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “This achievement underscores our commitment to healthcare innovation through biosimilars and our mission to meet the growing needs in critical therapeutic areas.”

The FDA approval was based on totality of evidence including analytical, non-clinical data, and clinical data. A randomized, double-blind, three-arm, parallel group, single-dose Phase 1 study demonstrated the pharmacokinetic (PK) equivalence between SB16, EU-sourced denosumab (EU-DEN), and US-sourced denosumab (US-DEN) in healthy male participants. The primary PK endpoints were met, in terms of area under the concentration-time curve (AUC) from time zero to infinity, AUC from time zero to the last quantifiable concentration, and maximum serum concentration.¹ In addition, a randomized, double-blind, multi-center Phase 3 study demonstrated equivalent efficacy and comparable safety, immunogenicity, PK, and pharmacodynamics (PD) profiles between SB16 and reference denosumab (DEN) in postmenopausal osteoporosis (PMO) patients. The primary endpoint was met in terms of percent (%) change from baseline in lumbar spine bone mineral density (BMD) at Month 12, and a follow-up up to Month 18 demonstrated switching to SB16 from DEN were comparable up to Month 18 in terms of efficacy, PK, PD, safety and immunogenicity.^2,3

OSPOMYV and XBRYK, marks Samsung Bioepis’ 9^th and 10^th FDA approved medicines as well as the company’s first FDA approval for an endocrinology biosimilar, setting another milestone for the company to broaden its biosimilar portfolio that cover a spectrum of therapeutic areas including immunology, oncology, ophthalmology, hematology and endocrinology.

OSPOMYV™ (denosumab-dssb) injection, for subcutaneous use

Ospomyv is a RANK ligand (RANKL) inhibitor indicated for treatment:

• of postmenopausal women with osteoporosis at high risk for fracture
• to increase bone mass in men with osteoporosis at high risk for fracture
• of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
• to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
• to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

SELECTED SAFETY INFORMATION

CONTRAINDICATIONS

• Hypocalcemia
• Pregnancy
• Known hypersensitivity to denosumab products

WARNINGS AND PRECAUTIONS

• Hypocalcemia: Pre-existing hypocalcemia must be corrected before initiating Ospomyv. May worsen, especially in patients with renal impairment. Adequately supplement all patients with calcium and vitamin D. Concomitant use of calcimimetic drugs may also worsen hypocalcemia risk. Evaluate for presence of chronic kidney disease mineral-bone disorder. Monitor serum calcium.
• Same Active Ingredient: Patients receiving Ospomyv should not receive other denosumab products concomitantly.
• Hypersensitivity including anaphylactic reactions may occur. Discontinue permanently if a clinically significant reaction occurs.
• Osteonecrosis of the jaw: Has been reported with denosumab products. Monitor for symptoms.
• Atypical femoral fractures: Have been reported. Evaluate patients with thigh or groin pain to rule out a femoral fracture.
• Multiple vertebral fractures have been reported following treatment discontinuation. Patients should be transitioned to another antiresorptive agent if Ospomyv is discontinued.
• Serious infections including skin infections: May occur, including those leading to hospitalization. Advise patients to seek prompt medical attention if they develop signs or symptoms of infection, including cellulitis.
• Dermatologic reactions: Dermatitis, rashes, and eczema have been reported. Consider discontinuing Ospomyv if severe symptoms develop.
• Severe bone, joint, muscle pain may occur. Discontinue use if severe symptoms develop.
• Suppression of bone turnover: Significant suppression has been demonstrated. Monitor for consequences of bone over-suppression.

These highlights do not include all the information needed to use OSPOMYV safely and effectively. See full prescribing information for OSPOMYV HERE, which includes the Boxed Warning, Medication Guide and Instructions for Use.

XBRYK™ (denosumab-dssb) injection, for subcutaneous use

Xbryk is a RANK ligand (RANKL) inhibitor indicated for:

• Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
• 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.
• Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

SELECTED SAFETY INFORMATION

CONTRAINDICATIONS

• Hypocalcemia
• Known clinically significant hypersensitivity to denosumab products

WARNINGS AND PRECAUTIONS

• Same Active Ingredient: Patients receiving Xbryk should not receive other denosumab products concomitantly.
• Hypersensitivity reactions including anaphylaxis may occur. Discontinue permanently if a clinically significant reaction occurs.
• Hypocalcemia: Denosumab products can cause severe symptomatic hypocalcemia. Fatal cases have been reported with denosumab products use. Correct hypocalcemia prior to initiating Xbryk. Monitor calcium levels during therapy, especially in the first weeks of initiating therapy, and adequately supplement all patients with calcium and vitamin D.
• Osteonecrosis of the jaw (ONJ) has been reported in patients receiving denosumab products. Perform an oral examination prior to starting Xbryk. Monitor for symptoms. Avoid invasive dental procedures during treatment with Xbryk.
• Atypical femoral fracture: Evaluate patients with thigh or groin pain to rule out a femoral fracture.
• Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons: Monitor patients for signs and symptoms of hypercalcemia, and manage as clinically appropriate.
• Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation: When Xbryk treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures.
• Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus and to use effective contraception.

These highlights do not include all the information needed to use XBRYK safely and effectively. See full prescribing information for XBRYK HERE, which includes the Boxed Warning, Medication Guide and Instructions for Use.

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. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X, LinkedIn.

¹ Lee HA, Kim S, Seo H, Kim S. A phase I, randomized, double-blind, single-dose pharmacokinetic study to evaluate the biosimilarity of SB16 (proposed denosumab biosimilar) with reference denosumab in healthy male subjects. Expert Opin Investig Drugs. 2023 Jul-Dec;32(10):959-966. doi: 10.1080/13543784.2023.2273510. Epub 2023 Nov 6. PMID: 37870163.

² Langdahl B, Chung YS, Plebanski R, Czerwinski E, Dokoupilova E, Supronik J, Rosa J, Mydlak A, Rowińska-Osuch A, Baek KH, Urboniene A, Mordaka R, Ahn S, Rho YH, Ban J, Eastell R. Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12. J Clin Endocrinol Metab. 2024 Sep 7:dgae611. doi: 10.1210/clinem/dgae611. Epub ahead of print. PMID: 39243386.

³ Richard Eastell, Bente Langdahl, Yoon-Sok Chung, Rafal Plebanski, Edward Czerwinski,Eva Dokoupilova, Jerzy Supronik, Jan Rosa, Andrzej Mydlak, Anna Rowinska-Osuch, Ki-Hyun Baek, Audrone Urboniene, Robert Mordaka, Sohui Ahn, Young Hee Rho, Jisuk Ban. A Randomized, Double-blind, Phase III Study to Compare SB16 (Proposed Denosumab Biosimilar) to Reference Denosumab in Patients with Postmenopausal Osteoporosis: 18-Month Results. Oral presentation at 2024 European Calcified Tissue Society (ECTS) Congress. May 25-28, 2024. Marseille, France.

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