- Submission supported by comprehensive analytical and clinical data package
- Denosumab indicated for treating variety of conditions including osteoporosis in postmenopausal women1,2
- Sandoz continues to build biosimilars portfolio to increase patient access to high-quality therapies and support healthcare system sustainability
BASEL, Switzerland I February 06, 2023 I Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for proposed biosimilar denosumab.
The application includes all indications covered by the reference medicines Prolia® (denosumab)* and Xgeva® (denosumab)* for treating a variety of conditions, including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer that has spread to the bone, giant cell tumor of the bone, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.1,2
“In addition to being an important medicine for cancer of the bone, denosumab is critical in the treatment of osteoporosis and potential prevention of osteoporosis-related fractures that so many women over 50 are at risk of,” said Keren Haruvi, President, Sandoz Inc. and Head of North America.
“We are proud to be among the first to submit a BLA for a denosumab biosimilar as, if approved, it could increase patient access to an affordable, high-quality, potentially disease-modifying treatment across the US, while also delivering savings for healthcare systems.”
In the US alone, more than 10 million adults over age 50 are estimated to have osteoporosis, of whom more than 80% are women.3 It is predicted that one in two of these women and one in four men will have an osteoporosis-related fracture in their lifetimes.4 Osteoporosis-related fractures may lead to diminished quality of life, disability, and even death.5
The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study. Results confirmed that the proposed biosimilar denosumab matches the reference medicine in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in women with postmenopausal osteoporosis; and contributes to demonstration of similarity, which is the basis for use in all indications.
Sandoz biosimilars help patients, in areas including immunology, oncology, supportive care and endocrinology, access critical and potentially life-changing medicines sustainably and affordably. Sandoz has a leading global portfolio with eight marketed biosimilars and a further 15-plus in various stages of development.
About denosumab
Denosumab is a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue).1 By binding to and inhibiting RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone loss, and subsequently the likelihood of fractures and other serious bone conditions.6
References
- Amgen Inc. Prolia® (Denosumab): Prescribing Information. Available from: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Prolia/prolia_pi.pdf [Last accessed: January 2023].
- Amgen Inc. Xgeva® (Denosumab): Prescribing Information. Available from: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/xgeva/xgeva_pi.pdf [Last accessed: January 2023].
- Wright, N.C., et al., The recent prevalence of osteoporosis and low bone mass in the United States based on bone mineral density at the femoral neck or lumbar spine. J Bone Miner Res, 2014. 29(11): p. 2520-6.
- Cleveland Clinic Osteoporosis: Symptoms, Causes, Tests & Treatment. Available from: https://my.clevelandclinic.org/health/diseases/4443-osteoporosis [Last accessed: January 2023].
- Osteoporosis and the Burden of Osteoporosis-Related Fractures. Available from: https://www.ajmc.com/view/a357_11ma7__dempster_s164to169 [Last accessed: January 2023].
- International Osteoporosis Foundation. Facts and Statistics. Available from: https://www.osteoporosis.foundation/facts-statistics/epidemiology-of-osteoporosis-and-fragility-fractures [Last accessed: January 2023].
*Prolia® and Xgeva® are registered trademarks of Amgen Inc.
About Sandoz
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering major therapeutic areas, accounted for 2022 sales of USD 9.2 billion.
SOURCE: Sandoz
Post Views: 1,024
- Submission supported by comprehensive analytical and clinical data package
- Denosumab indicated for treating variety of conditions including osteoporosis in postmenopausal women1,2
- Sandoz continues to build biosimilars portfolio to increase patient access to high-quality therapies and support healthcare system sustainability
BASEL, Switzerland I February 06, 2023 I Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for proposed biosimilar denosumab.
The application includes all indications covered by the reference medicines Prolia® (denosumab)* and Xgeva® (denosumab)* for treating a variety of conditions, including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer that has spread to the bone, giant cell tumor of the bone, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.1,2
“In addition to being an important medicine for cancer of the bone, denosumab is critical in the treatment of osteoporosis and potential prevention of osteoporosis-related fractures that so many women over 50 are at risk of,” said Keren Haruvi, President, Sandoz Inc. and Head of North America.
“We are proud to be among the first to submit a BLA for a denosumab biosimilar as, if approved, it could increase patient access to an affordable, high-quality, potentially disease-modifying treatment across the US, while also delivering savings for healthcare systems.”
In the US alone, more than 10 million adults over age 50 are estimated to have osteoporosis, of whom more than 80% are women.3 It is predicted that one in two of these women and one in four men will have an osteoporosis-related fracture in their lifetimes.4 Osteoporosis-related fractures may lead to diminished quality of life, disability, and even death.5
The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study. Results confirmed that the proposed biosimilar denosumab matches the reference medicine in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in women with postmenopausal osteoporosis; and contributes to demonstration of similarity, which is the basis for use in all indications.
Sandoz biosimilars help patients, in areas including immunology, oncology, supportive care and endocrinology, access critical and potentially life-changing medicines sustainably and affordably. Sandoz has a leading global portfolio with eight marketed biosimilars and a further 15-plus in various stages of development.
About denosumab
Denosumab is a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue).1 By binding to and inhibiting RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone loss, and subsequently the likelihood of fractures and other serious bone conditions.6
References
- Amgen Inc. Prolia® (Denosumab): Prescribing Information. Available from: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Prolia/prolia_pi.pdf [Last accessed: January 2023].
- Amgen Inc. Xgeva® (Denosumab): Prescribing Information. Available from: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/xgeva/xgeva_pi.pdf [Last accessed: January 2023].
- Wright, N.C., et al., The recent prevalence of osteoporosis and low bone mass in the United States based on bone mineral density at the femoral neck or lumbar spine. J Bone Miner Res, 2014. 29(11): p. 2520-6.
- Cleveland Clinic Osteoporosis: Symptoms, Causes, Tests & Treatment. Available from: https://my.clevelandclinic.org/health/diseases/4443-osteoporosis [Last accessed: January 2023].
- Osteoporosis and the Burden of Osteoporosis-Related Fractures. Available from: https://www.ajmc.com/view/a357_11ma7__dempster_s164to169 [Last accessed: January 2023].
- International Osteoporosis Foundation. Facts and Statistics. Available from: https://www.osteoporosis.foundation/facts-statistics/epidemiology-of-osteoporosis-and-fragility-fractures [Last accessed: January 2023].
*Prolia® and Xgeva® are registered trademarks of Amgen Inc.
About Sandoz
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering major therapeutic areas, accounted for 2022 sales of USD 9.2 billion.
SOURCE: Sandoz
Post Views: 1,024
