Celltrion’s biosimilar portfolio continues to grow, expanding treatment options to reach more patients in Canada
Celltrion announced that Health Canada has approved Stoboclo and Osenvelt (CT-P41), biosimilars referencing Prolia and Xgeva, respectively for all indications of reference products.
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“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.”
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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® ,SteQeyma® (ustekinumab), Omlyclo.
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Source- businesswire
