Health Canada approves Celltrion’s Stoboclo^® and Osenvelt^®(CT-P41), denosumab biosimilars for the treatment of all indications approved for the reference products, Prolia^® and Xgeva^®, respectively

TORONTO--(BUSINESS WIRE)--Celltrion today announced that Health Canada has approved Stoboclo^® and Osenvelt^® (CT-P41), biosimilars referencing Prolia^® and Xgeva^®, respectively for all indications of reference products.^1,2

“The approval of Stoboclo and Osenvelt underscores our commitment to developing patient-centric therapies, particularly for incurable forms of disease such as osteoporosis where patients face difficult prognoses,” said Jungyong Shin, Managing Director at Celltrion Healthcare Canada. “We are proud to lead the biosimilar industry with our expanded portfolio, offering significant cost-saving potential while enhancing patient access and supporting the Canadian skeletal disorders community.”

The Health Canada approval is based on robust clinical evidence, including results from a Phase III clinical trial in postmenopausal women with osteoporosis designed to evaluate the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety and immunogenicity of CT-P41 to reference denosumab. Study results demonstrated that CT-P41 had equivalent efficacy and pharmacodynamics to reference denosumab with similar pharmacokinetics and comparable safety and immunogenicity profiles.³

Stoboclo and Osenvelt are Celltrion’s sixth biosimilars approved in Canada after receiving the company’s approval of Remdantry™/ Remsima^® SC (infliximab), Yuflyma^® (adalimumab), Vegzelma^® (bevacizumab), SteQeyma^® (ustekinumab), Omlyclo^® (omalizumab).

Notes to Editors:

About Stoboclo^®

Stoboclo^® is a receptor activator of NF-κb ligand (RANKL) inhibitor (bone metabolism regulator) developed as a biosimilar referencing Prolia^® (denosumab) approved in Canada. Stoboclo has been approved for indications approved for the reference products, Prolia. Denosumab biosimilars and reference product (Prolia) have been approved in Canada to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to increase bone mass in men with nonmetastatic prostate cancer receiving androgen deprivation therapy (ADT), to increase bone mass in women with nonmetastatic breast cancer receiving adjuvant aromatase inhibitor (AI) therapy, and to increase bone mass for the treatment and prevention of glucocorticoid-induced osteoporosis in women and men at high risk for fracture. Stoboclo is available as 60 mg / mL solution for injection in prefilled syringe.¹

About Osenvelt^®

Osenvelt^® is a receptor activator of NF-κb ligand (RANKL) inhibitor (bone metabolism regulator) developed as a biosimilar referencing Xgeva^® (denosumab) approved in Canada. Osenvelt has been approved for indications approved for the reference products, Xgeva. Denosumab biosimilars and reference product (Xgeva) are indicated to reduce the risk of developing skeletal-related events in patients with multiple myeloma and in patients with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer, and other solid tumours, to treat 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, and to treat hypercalcemia of malignancy that is refractory to intravenous bisphosphonate. Osenvelt is available as 120 mg/1.7 mL solution for injection in single-use vial.²

About Celltrion Inc.

Celltrion is a leading biopharmaceutical company that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook.

About Celltrion Healthcare Canada Limited

Celltrion Healthcare Canada is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with Health Canada regulations. With the approval of Stoboclo^® and Osenvelt^®, Celltrion now has eight products across six biosimilars approved by Health Canada: Remdantry™/ Remsima^® SC (infliximab), Yuflyma^® (adalimumab), Vegzelma^® (bevacizumab), SteQeyma^® (ustekinumab), Omlyclo^® (omalizumab), Stoboclo^® and Osenvelt^® (denosumab). For more information, please visit: https://www.celltrionhealthcare.ca

Stoboclo^® and Osenvelt^® are trademarks of Celltrion, Inc. and are used under license.
Prolia^® and Xgeva^® are registered trademarks of Amgen Inc.

¹ Stoboclo Product Monograph. Celltrion Inc. September 2025. Product information from Health Canada.
² Osenvelt Product Monograph. Celltrion Inc. September 2025. Product information from Health Canada.
³ Reginster JY et al. Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis. Osteoporos Int. 2024 Nov;35(11):1919-1930. doi: 10.1007/s00198-024-07161-x. Epub 2024 Jul 23. PMID: 39042292; PMCID: PMC11499533. Available at: https://pubmed.ncbi.nlm.nih.gov/39042292/ [Last accessed September 2025].