» Osteoporosis: Sandoz Announces Positive Results for Phase I/III Trials of Its Biosimilar Denosumab MyPharma Editions

Posted on Friday, September 30, 2022

Sandoz, a global leader in generic and biosimilar medicines, has just announced new advances in its biosimilar medicines in development, with the publication of positive results from the ROSALIA integrated Phase I/III clinical trial for its treatment denosumab .

“Biosimilars can have a significant positive impact on patient access to medicines and generate much-needed cost savings for the sustainability of healthcare systems,” said Florian Bieber, Global Head of Biopharmaceutical Development at Sandoz. “With this important step, we are moving towards wider availability of this essential medicine for people with osteoporosis through this biosimilar version at a controlled price. »

Denosumab is indicated for the treatment of a variety of conditions: osteoporosis in postmenopausal women and men at increased risk of fracture, treatment-related bone loss, prevention of skeletal-related complications in cancer patients with bone metastases, and giant cell tumor of bone2,3,4,5.

The results of the integrated phase I/III clinical study confirm that, in the indications concerned, the biosimilar medicinal product is equivalent to the reference medicinal product (princeps) in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity. They make it possible to demonstrate its similarity, the demonstration of which is essential to allow the use of the product in all indications.

About 500 million men and women in the world could suffer from osteoporosis1, a pathology responsible for 8.9 million fractures per year, or one every three seconds1. By 2050, hip fractures are expected to increase by 240% in women and 310% in men compared to 19901.

Sandoz biosimilar medicines provide patients with sustainable and affordable access to essential medicines that have the potential to have a major impact on patients’ lives, in therapeutic areas such as immunology, oncology, nephrology and endocrinology. Sandoz has a leading global portfolio, which includes eight biosimilars already made available and more than fifteen others in various stages of development.

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References
1. International Osteoporosis Foundation. Facts and Statistics. Available at: [consulté pour la dernière fois en août 2022].
2. Amgen Europe BV Xgeva® (denosumab): Summary of Product Characteristics. Available at: [consulté pour la dernière fois en août 2022].
3. Amgen Europe BV Prolia® (denosumab): Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/prolia-epar-product-information_fr.pdf
4. Amgen Inc. Prolia® (Denosumab): Prescribing Information. Available at: [consulté pour la dernière fois en août 2022].
5. Amgen Inc. Xgeva® (Denosumab): Prescribing Information. Available at: [consulté pour la dernière fois en août 2022].
6. www.clinicaltrials.gov. Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients with Postmenopausal Osteoporosis. NCT03974100. Available at: [consulté pour la dernière fois en août 2022].

Source: Sandoz

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» Osteoporosis: Sandoz Announces Positive Results for Phase I/III Trials of Its Biosimilar Denosumab MyPharma Editions


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