US FDA accepted Sandoz Biologics License Application for proposed biosimilar denosumab


The submission is supported by comprehensive analytical and clinical data packages. Denosumab indicated for treating variety of conditions including osteoporosis in postmenopausal women1,2. Sandoz will continue to build biosimilars portfolio to increase patient access to high-quality therapies and support healthcare system sustainability.


Article Summary 

Sandoz, a global leader in off-patent (generic and biosimilar) medicines, announced that its Biologics License Application (BLA) for proposed biosimilar denosumab has been accepted by the US Food and Drug Administration (FDA).


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.


“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.”


The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study. 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. 


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: Novartis, 6th Feb 2023) 


Leave A Comment

Leave a Reply

Your email address will not be published.