Sandoz Announces Further Progress in its Biosimilars Portfolio, with the Publication of Positive Results from the Integrated Phase I/III Clinical Trial of Denosumab

Sandoz Announces Further Progress in its Biosimilars Portfolio, with the Publication of Positive Results from the Integrated Phase I/III Clinical Trial of Denosumab

  • The ROSALIA study met the primary endpoints, confirming that the proposed biosimilar denosumab matches the reference product in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in postmenopausal women with osteoporosis

  • Osteoporosis is responsible for 8.9 million bone fractures a year, including debilitating hip fractures – a number that is expected to rise dramatically over the next two decades1

  • Positive trial results follow EMA and FDA filing acceptance of two other proposed Sandoz biosimilars, adalimumab HCF and natalizumab

Basel, September 19, 2022 – Sandoz, a global leader in off-patent medicines (generics and biosimilars), today announces further progress in its biosimilar product portfolio, with the publication of positive results from the integrated Phase I/III clinical trial ROSALIA for its proposed biosimilar denosumab.

“Biosimilars have the potential to create a substantial positive impact on patient access and the sustainability of healthcare systems,” said Florian Bieber, Global Head of Development, Sandoz Biopharmaceuticals. “Therefore, this important milestone means we are one step closer to providing people with osteoporosis with access to a more affordable biosimilar version of this essential medicine, which could help modify the course of their disease.”

Denosumab is indicated for the treatment of a variety of conditions, including osteoporosis in postmenopausal women, in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal complications from cancer that has spread tumor and giant cell tumor of the bone2,3,4.5.

The results of the integrated phase I/III study confirm that the biosimilar corresponds to the reference drug in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in the respective indications; and contributes to the demonstration of similarity, which is the basis of use in all indications.

About 500 million men and women worldwide could be affected by osteoporosis1which causes 8.9 million fractures a year – a fracture every three seconds1. By 2050, hip fractures are expected to increase by 240% in women and 310% in men compared to 19901.

The results come shortly after Sandoz confirmed acceptance of license applications for two other proposed biosimilars. In July 2022, the application for natalizumab, the first proposed biosimilar for multiple sclerosis, was accepted for review by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). In June 2022, the EMA and FDA accepted Sandoz’s applications for review for the 100 mg/mL high-strength (HCF) formulation of its biosimilar adalimumab.

Sandoz biosimilars help patients in areas such as immunology, oncology, nephrology, supportive care and endocrinology gain sustainable and affordable access to essential and potentially life-changing medicines . Sandoz has a leading global portfolio with eight biosimilars marketed and more than 15 others in various stages of development.

About ROSALIA6
In the ROSALIA study, 527 postmenopausal women with osteoporosis were randomized to receive either the biosimilar denosumab or the reference medicine for up to 78 weeks of treatment. The objectives were to demonstrate similar efficacy in terms of modification of bone mineral density in the lumbar spine, as well as similar pharmacokinetics and pharmacodynamics. The global clinical program for the biosimilar denosumab has been developed in consultation with key regulatory agencies and the results of this clinical study are expected to support regulatory approval.

About denosumab
Denosumab is a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in the breakdown of bone tissue)2. By binding to and inhibiting RANKL, denosumab decreases the production and activity of osteoclasts, leading to a reduction in bone loss, and subsequently the likelihood of fractures and other serious bone conditions2.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential”, “may”, “will”, “plans”, ” “may”, “could”, “should”, “expect”, “anticipate”, “expect”, “believe”, “commit”, “investigate”, “pipeline”, “initiate” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling of the investigational or approved products described in this press release, or regarding potential future revenues from such products. place undue reliance on these statements. These forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to important known and unknown risks and uncertainties. or more of these risks or uncertainties materialize, or if underlying assumptions prove incorrect, actual results could differ materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indication or labeling in any particular market or time. Nor can there be any guarantee that, if approved, these generic or biosimilar products will be approved for all indications included in the label of the reference product. There is also no guarantee that these products will be commercially successful in the future. In particular, our expectations regarding these products could be affected by, among other things, uncertainties inherent in research and development, including the results of clinical trials and further analysis of existing clinical data; regulatory actions or delays or government regulation generally; particular prescribing preferences of physicians and patients; competition generally, including the potential approval of additional generic or biosimilar versions of these products; global trends toward health care cost containment, including pressures from governments, payers and the general public on pricing and reimbursement and demands for increased price transparency; the results of litigation, including intellectual property litigation or other legal efforts to prevent or limit the sale of its products by Sandoz; general political, economic and business conditions, including the effects and efforts to mitigate pandemic diseases such as COVID-19; security, quality, data integrity or manufacturing issues; potential or actual breaches of data security and data privacy, or disruptions to our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F filed with the Securities and Exchange United States Commission. Novartis is providing the information in this press release as of this date and undertakes no obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Sandoz
Sandoz, a division of Novartis, is a global leader in generic medicines and biosimilars. Our goal is to create pioneering access for patients by developing and commercializing innovative and 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, spanning all major therapeutic areas, accounted for $9.6 billion in sales in 2021.

Sandoz on social networks:
LinkedIn: https://www.linkedin.com/company/sandoz
Twitter: https://twitter.com/sandoz_global
Facebook: https://www.facebook.com/sandozglobal/
Instagram: https://www.instagram.com/sandozglobal

CEO Richard Saynor on LinkedIn: https://www.linkedin.com/in/richard-saynor/

References

  1. International Osteoporosis Foundation. Facts and statistics. Available at: https://www.osteoporosis.foundation/facts-statistics/epidemiology-of-osteoporosis-and-fragility-fractures [Last accessed: August 2022].

  2. Amgen Europe BV Xgeva® (Denosumab): Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/xgeva-epar-product-information_en.pdf [Last accessed: August 2022].

  3. Amgen Europe BV Prolia® (Denosumab): Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/prolia [Last accessed: August 2022].

  4. Amgen Inc. Prolia® (Denosumab): Prescribing information. Available at: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Prolia/prolia_pi.pdf [Last accessed: August 2022].

  5. Amgen Inc. Xgeva® (Denosumab): Prescribing information. Available at: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/xgeva/xgeva_pi.pdf [Last accessed: August 2022].

  6. www.clinicaltrials.gov. Study investigating the PK, PD, efficacy, safety and immunogenicity of biosimilar denosumab (GP2411) in patients with postmenopausal osteoporosis. NCT03974100. Available at: https://clinicaltrials.gov/ct2/show/NCT03974100?term=GP2411&rank=1 [Last accessed: August 2022].

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