Sandoz Advertising and marketing Authorization Purposes for proposed biosimilar denosumab accepted by EMA

  • Submissions supported by complete analytical and scientific information bundle together with a Part I PK/PD similarity research and the built-in Part I/III ROSALIA scientific trial
  • Denosumab is indicated for treating a wide range of situations, together with osteoporosis in postmenopausal girls, prevention of skeletal associated issues in most cancers that has unfold to the bone and unresectable large cell tumor of the bone1,2
  • Sandoz continues to construct its biosimilars portfolio to extend affected person entry to high-quality, inexpensive biologics and generate financial savings for well being programs

Basel, Might 25, 2023 — Sandoz, a worldwide chief in off-patent (generic and biosimilar) medicines, at the moment introduced that the European Medicines Company (EMA) has accepted the advertising and marketing authorization purposes (MAA) for proposed biosimilar denosumab for regulatory assessment.

The 2 purposes embrace all indications lined by the reference medicines Prolia® (denosumab)* and Xgeva® (denosumab)*, respectively, for treating a wide range of situations, together with osteoporosis in postmenopausal girls and in males at elevated threat of fractures, treatment-induced bone loss, prevention of skeletal associated issues in most cancers which have unfold to the bone, and large cell tumor of the bone.1,2

“Sandoz is likely one of the first to have its purposes for a proposed biosimilar denosumab accepted by the EMA. If authorised, this has the potential to supply folks dwelling with osteoporosis and most cancers of the bone or bone metastasis entry to an economical and high-quality remedy choice.” stated Florian Bieber, Growth Platform Head Biopharmaceuticals and Chief Medical Officer, Sandoz. “This information follows the latest utility acceptance by the US Meals and Drug Administration and helps our continued dedication to offering expanded entry to life-changing therapies, whereas additionally serving to over-burdened healthcare programs generate financial savings.”

Roughly 500 million women and men worldwide could also be affected by osteoporosis, which causes 8.9 million fractures yearly – or one fracture each three seconds.3 By 2050, hip fractures are projected to extend by 240% in girls and 310% in males in comparison with 1990.3 Prevalence of skeletal associated issues in most cancers is estimated to be as excessive as 63% for breast most cancers, 59% for lung most cancers and 52% for prostate most cancers. Skeletal associated issues in most cancers are related to lack of mobility and social functioning, lowered high quality of life, elevated well being care expenditure and worse survival.4,5,6

The EMA purposes are based mostly on a complete analytical and scientific information bundle, comprised of information from a Part I PK/PD similarity research in wholesome volunteers and the built-in Part I/III ROSALIA research. The information bundle confirmed the denosumab biosimilar matches the reference medication when it comes to pharmacokinetics, pharmacodynamics, efficacy, security, and immunogenicity within the respective research populations; and contributes to the demonstration of similarity, which is the idea to be used in all indications for which Xgeva and Prolia are authorised.

Sandoz is dedicated to serving to hundreds of thousands of sufferers sustainably and affordably entry vital and probably life-changing biologic medicines throughout a variety of areas together with immunology, oncology, supportive care and endocrinology. It has a number one world portfolio with eight marketed biosimilars and an additional 24 property in varied phases of improvement. Since launching the primary biosimilar in Europe in 2006, Sandoz has confirmed biosimilars create early and expanded affected person entry to life-altering medicines whereas rising healthcare financial savings and creating competitors that fuels innovation and improvement of recent and enhanced therapies in areas of unmet want.

About denosumab
Denosumab is a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells concerned in breaking down bone tissue).1 By binding to and inhibiting RANKL, denosumab decreases the manufacturing and exercise of osteoclasts, leading to a discount of bone loss, and subsequently the probability of fractures and different critical bone situations.7

This press launch accommodates forward-looking statements throughout the which means of the USA Non-public Securities Litigation Reform Act of 1995. Ahead-looking statements can usually be recognized by phrases reminiscent of “potential,” “can,” “will,” “plan,” “might,” “may,” “would,” “anticipate,” “anticipate,” “look ahead,” “imagine,” “dedicated,” “investigational,” “pipeline,” “launch,” or related phrases, or by categorical or implied discussions relating to potential advertising and marketing approvals, new indications or labeling for the investigational or authorised merchandise described on this press launch, or relating to potential future revenues from such merchandise. You shouldn’t place undue reliance on these statements. Such forward-looking statements are based mostly on our present beliefs and expectations relating to future occasions, and are topic to vital recognized and unknown dangers and uncertainties. Ought to a number of of those dangers or uncertainties materialize, or ought to underlying assumptions show incorrect, precise outcomes might fluctuate materially from these set forth within the forward-looking statements. There will be no assure that the investigational or authorised merchandise described on this press launch might be submitted or authorised on the market or for any further indications or labeling in any market, or at any explicit time. Neither can there be any assure that, if authorised, such generic or biosimilar merchandise might be authorised for all indications included within the reference product’s label. Nor can there be any assure that such merchandise might be commercially profitable sooner or later. Particularly, our expectations relating to such merchandise may very well be affected by, amongst different issues, the uncertainties inherent in analysis and improvement, together with scientific trial outcomes and extra evaluation of present scientific information; regulatory actions or delays or authorities regulation usually; the actual prescribing preferences of physicians and sufferers; competitors on the whole, together with potential approval of further generic or biosimilar variations of such merchandise; world developments towards well being care value containment, together with authorities, payor and basic public pricing and reimbursement pressures and necessities for elevated pricing transparency; litigation outcomes, together with mental property disputes or different authorized efforts to forestall or restrict Sandoz from promoting its merchandise; basic political, financial and enterprise situations, together with the consequences of and efforts to mitigate pandemic illnesses reminiscent of COVID-19; security, high quality, information integrity or manufacturing points; potential or precise information safety and information privateness breaches, or disruptions of our data expertise programs, and different dangers and elements referred to in Novartis AG’s present Kind 20-F on file with the US Securities and Change Fee. Novartis is offering the data on this press launch as of this date and doesn’t undertake any obligation to replace any forward-looking statements contained on this press launch because of new data, future occasions or in any other case.


  1. European Medicines Company (EMA). Prolia® (Denosumab): Prescribing Info. Obtainable from: [Last accessed: May 2023].
  2. European Medicines Company (EMA). Xgeva® (Denosumab): Prescribing Info. Obtainable from: [Last accessed: May 2023].
  3. Worldwide Osteoporosis Basis. Info and Statistics. Obtainable from: https://www.osteoporosis.basis/facts-statistics/epidemiology-of-osteoporosis-and-fragility-fractures [Last accessed: May 2023].
  4. Bhowmik D. et al. Present Medical Analysis and Opinion, 35:3, 513-523.
  5. Cadieux B. et al. Journal of Bone Oncology, 2022, 33: 1-13.
  6. Coleman R. et al. Bone well being in most cancers: ESMO Medical Follow Pointers, 2020.
  7. Amgen Europe B.V. Xgeva® (Denosumab): Abstract of Product Traits. Obtainable from: [Last accessed: May 2023].

*Prolia® and Xgeva® are registered logos of Amgen Inc.

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About Sandoz
Sandoz, a Novartis division, is a worldwide chief in generic prescription drugs and biosimilars. Our function is to pioneer entry for sufferers by growing and commercializing novel, inexpensive approaches that handle unmet medical wants. Our ambition is to be the world’s main and most valued generics firm. Our broad portfolio of high-quality medicines, protecting main therapeutic areas, accounted for 2022 gross sales of USD 9.2 billion.

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