A Randomized, Double-blind, Multicenter Integrated Phase I/III Study in Postmenopausal Women With Osteoporosis to Compare the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety and Immunogenicity of GP2411 (Proposed Biosimilar Denosumab) and Prolia® (EU-authorized)

This study was conducted to assess if there were any clinically meaningful differences in pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between GP2411 (proposed biosimilar denosumab) and EU-authorized Prolia® (denosumab).

开始日期2019-07-02

申办/合作机构

Sandoz Group AG

[+1]

100 项与地舒单抗生物类似药 (Novartis) 相关的临床结果

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100 项与地舒单抗生物类似药 (Novartis) 相关的专利（医药）

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项与地舒单抗生物类似药 (Novartis) 相关的文献（医药）

2024-11-01·CLINICAL THERAPEUTICS

The Totality of Evidence for SDZ-deno: A Biosimilar to Reference Denosumab

Review

作者: Eastell, Richard ; Sekhar, Susmit ; Renner, Oliver ; Body, Jean-Jacques ; Vogg, Barbara ; Poetzl, Johann ; Kivitz, Alan ; Schwebig, Arnd ; Krivtsova, Natalia

PURPOSE:

Sandoz biosimilar denosumab (GP2411 [SDZ-deno]; Jubbonti/Wyost) is approved by the US FDA, EMA and Health Canada for all indications of reference denosumab (REF-deno; Prolia/Xgeva), a fully human IgG2κ monoclonal antibody that binds with high affinity and specificity to receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab blocks RANKL, preventing bone resorption and loss of bone density/architecture in conditions characterized by excessive bone loss such as osteoporosis in postmenopausal women and metastatic bone disease, among others.

METHODS:

This narrative review summarizes the totality of evidence (ToE) for SDZ-deno that supported its approval as Jubbonti/Wyost in the EU and US.

FINDINGS:

Analytical evaluation indicated that SDZ-deno has high purity and structural homology with REF-deno. SDZ-deno also demonstrated similar binding affinities, size and charge variants, and disulfide isoforms to REF-deno, and did not trigger clinically meaningful antibody-dependent cellular cytotoxicity. In clinical evaluation, SDZ-deno was similar to REF-deno in pharmacokinetics (PK) and pharmacodynamics (PD) in a 39-week Phase I study in 502 healthy male participants, and to REF-deno in a 72-week Phase III study in 527 postmenopausal women with osteoporosis. In both studies, the 90% and 95% confidence intervals (for PK and PD endpoints, respectively) of the geometric mean ratios for AUC_inf, C_max (and AUC_last in the Phase I study; PK endpoints), and area under the effect versus time curve of percent change from baseline in serum carboxy-terminal crosslinked telopeptide of type I collagen (PD endpoint), were fully contained within the prespecified equivalence margins (0.80, 1.25). The Phase III study also demonstrated SDZ-deno is similar in efficacy to REF-deno in postmenopausal women with osteoporosis, as the difference in percent change from baseline in lumbar spine bone mineral density at week 52 between REF-deno and SDZ-deno was fully contained within the prespecified equivalence margins (-1.45, 1.45). SDZ-deno was well tolerated in both studies. As the ToE has established biosimilarity of SDZ-deno and REF-deno, extrapolation to all indications is justified based on the common mechanism of action and the comparable PK, safety, and immunogenicity across all indications.

IMPLICATIONS:

The ToE for SDZ-deno suggests it will be an effective biosimilar to REF-deno, and its lower unit price is anticipated to increase the number of appropriate patients who will benefit.

2024-08-05·JOURNAL OF BONE AND MINERAL RESEARCH

Correction to: Equivalence trial of proposed denosumab biosimilar GP2411 and reference denosumab in postmenopausal osteoporosis: the ROSALIA study

2024-04-19·Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research

Equivalence trial of proposed denosumab biosimilar GP2411 and reference denosumab in postmenopausal osteoporosis: the ROSALIA study

Article

作者: Vogg, Barbara ; Banerjee, Samik ; Jeka, Sławomir ; Żuchowski, Paweł ; Schwebig, Arnd ; Eastell, Richard ; Poetzl, Johann ; Sekhar, Susmit ; Dokoupilová, Eva ; Body, Jean-Jacques ; Krivtsova, Natalia ; Kivitz, Alan

Abstract:

Denosumab is a monoclonal antibody used to reduce risk of fractures in osteoporosis. ROSALIA was a multicenter, double-blind, randomized, integrated phase I/phase III study comparing the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and safety of proposed biosimilar denosumab GP2411 with reference denosumab (REF-DMAb) (Prolia®; Amgen). Postmenopausal women with osteoporosis were randomized 1:1 to 2 60-mg doses of GP2411 or REF-DMAb, one at study start and one at week 26. At week 52, the REF-DMAb group was re-randomized 1:1 to a third dose of REF-DMAb or switch to GP2411. The primary efficacy endpoint was percentage change from baseline (%CfB) in LS-BMD at week 52. Secondary efficacy endpoints were %CfB in LS-BMD, FN-BMD, and TH-BMD at weeks 26 and 78 (and week 52 for FN-BMD and TH-BMD). Primary PK and PD endpoints were the area under the serum concentration–time curve extrapolated to infinity and maximum drug serum concentration at week 26, and the area under the effect–time curve of the %CfB in serum CTX at week 26. Secondary PK and PD endpoints included drug serum concentrations and %CfB in serum CTX and P1NP during the study period. Similar efficacy was demonstrated at week 52, with 95% CIs of the difference in %CfB in LS-BMD between treatment groups fully contained within prespecified equivalence margins. Similarity in PK and PD was demonstrated at week 26. Immunogenicity was similar between groups and was not impacted by treatment switch. The rate of new vertebral fractures was comparable. Treatment-emergent adverse events were comparable between groups (63.6% [GP2411/GP2411]; 76.0% [REF-DMAb/REF-DMAb]; 76.6% [REF-DMAb/GP2411]). In conclusion, ROSALIA showed similar efficacy, PK and PD, and comparable safety and immunogenicity of GP2411 to REF-DMAb in postmenopausal osteoporosis.

项与地舒单抗生物类似药 (Novartis) 相关的新闻（医药）

2025-06-02

·PipelineReview

Sandoz launches first and only interchangeable denosumab biosimilars in US, providing new affordable treatment options for over 10 million patients[1]

BASEL, Switzerland I June 2, 2025 I Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, has announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are available to patients in the US starting today. WYOST® and Jubbonti® are the first and only interchangeable FDA-approved denosumab biosimilars and are approved to treat all indications of the reference medicines XGEVA®* (denosumab) and Prolia®* (denosumab), respectively.[2,3] This launch builds on Sandoz established leadership in biosimilars and oncology, dating back to the introduction of the first biosimilar in the US in 2015. WYOST® and Jubbonti® are key biosimilar value drivers that are integral to the Sandoz growth strategy, representing a significant step forward in advancing the Company’s ambition to be the biosimilar leader in the US. Keren Haruvi, President Sandoz North America, said: “Denosumab is a vital medicine for conditions such as osteoporosis and cancer-related skeletal events. Providing an additional high-quality, cost-effective treatment option helps improve access and affordability for US patients.” WYOST® and Jubbonti® have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines. WYOST® and Jubbonti® are approved as interchangeable with the reference medicines for all indications. WYOST® and Jubbonti® will be launching with an established Q code. Sandoz is providing comprehensive support resources for patients who are prescribed WYOST® and Jubbonti®, including reimbursement and financial support. Claire Gill, Chief Executive Officer, Bone Health and Osteoporosis Foundation, said: “Bone loss and cancer-related skeletal complications can have a profound impact on patients’ lives, but access to effective treatments has often been impacted by cost. With the introduction of new biosimilar options, patients now have access to more treatments they need and deserve.” Bone metastases occur when cancer cells move away from the original tumor site and into the bone, weakening its structure and often causing significant skeletal-related events (SREs) such as pain and fractures.[4] They are most common in patients with breast, prostate, lung, kidney and thyroid cancers and approximately 330,000 people in the US are living with bone metastases.[4] Osteoporosis is a condition that develops when bone mineral density and bone mass decrease causing the bones to become thinner, weaker and more likely to break.[5] Over 10 million US adults 50 years of age or older live with osteoporosis, with over 43 million at risk due to low bone mass.[1,5] Half of all women and a quarter of all men over the age of 50 will break a bone due to osteoporosis.[6] *XGEVA® and Prolia® are registered trademarks of Amgen Inc. About WYOST® (denosumab-bbdz) WYOST® 120 mg/1.7 mL (70 mg/mL) injection has been approved by the FDA as interchangeable with the reference medicine, a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue).[3,7] WYOST® is indicated in the US to prevent SREs in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.[7] This is not the complete list of all the safety information for Wyost. Please click to see full Prescribing Information for Wyost. About Jubbonti® (denosumab-bbdz) Jubbonti® 60 mg/1 mL injection has been approved by the FDA as interchangeable with the reference medicine, a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue).[2,8] Jubbonti® is indicated in the US to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.[8] This is not the complete list of all the safety information for Jubbonti. Please click to see full Prescribing Information for Jubbonti. REFERENCES [1] Sarafrazi N, Wambogo EA, Shepherd JA. Osteoporosis or Low Bone Mass in Older Adults: United States, 2017–2018. Centers for Disease Control and Prevention. 2021;405. Available at: https://www-cdc-gov.libproxy1.nus.edu.sg/nchs/products/databriefs/db405.htm [Last accessed: June 2025] [2] Food and Drug Administration. Prolia® (Ustekinumab): Medication Guide. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125320s213lbl.pdf [Last accessed: June 2025] [3] Food and Drug Administration. XGEVA® (Ustekinumab): Medication Guide. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125320s0000lbl.pdf [Last accessed: June 2025] [4] Moffitt Cancer Center. Bone Metastasis. Available at: https://www.moffitt.org/cancers/bone-metastasis/ [Last accessed: June 2025] [5] Food and Drug Administration. Osteoporosis. Available at: https://www.fda.gov/consumers/womens-health-topics/osteoporosis [Last accessed: June 2025] [6] American Academy of Orthopaedic Surgeons. Osteoporosis. Available at: https://orthoinfo.aaos.org/en/diseases–conditions/osteoporosis/ [Last accessed: June 2025] [7] WYOST®. Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761362s000lbl.pdf [Last accessed: June 2025] [8] Jubbonti®. Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761362s000lbl.pdf [Last accessed: June 2025] ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion. SOURCE: Sandoz

上市批准

2025-04-30

·PipelineReview

Sandoz enters global collaboration license agreement with Henlius to commercialize leading oncology therapy, ipilimumab, in multiple indications

BASEL, Switzerland I April 29, 2025 I Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, announced today that it has signed a global collaboration agreement with Shanghai Henlius Biotech, Inc. (Henlius, HKEX:02696) to commercialize a biosimilar of leading oncology therapy, ipilimumab. The agreement is milestone-based for a total consideration of up to USD 301 million, including an upfront payment of USD 31 million, and will target net reference-medicine sales of USD 2.5 billion[1]. Under the terms of the agreement, Sandoz has exclusive commercial rights for a biosimilar of ipilimumab in Australia, Canada, Europe, Japan and the US. The core sequence patent for ipilimumab expired in March 2025 in the US and will expire no later than February 2026 in the EU. Richard Saynor, CEO of Sandoz, said: “The global burden of cancer continues to grow and the potential to address unmet patient needs has never been greater.[3] This agreement offers us the chance to reach many more millions of patients, while helping to drive the long-term sustainability of healthcare systems.” The reference medicine, ipilimumab, is a monoclonal (CTLA-4) antibody-blocking medication, which is used alone or with other medicines to treat certain types of colorectal cancer, esophageal cancer, hepatocellular carcinoma (a type of liver cancer), malignant pleural mesothelioma, melanoma, non-small cell lung cancer, and renal cell carcinoma (a type of kidney cancer).[4,5,6] Henlius is developing its own proposed biosimilar of ipilimumab in an integrated Phase I/III trial in the unresectable hepatocellular carcinoma setting, targeting 656 patients to be enrolled (NCT06841185). Sandoz is developing its own proposed biosimilar of nivolumab in an integrated Phase I/III trial in the advanced melanoma setting, targeting 720 patients to be enrolled (NCT06587451). The reference medicine, nivolumab, (Opdivo®**) is a monoclonal (PD-1) antibody-blocking medication, which is used alone or with other medicines to treat more than 10 different cancer types. In combination with ipilimumab, nivolumab is indicated for the treatment of melanoma, malignant pleural mesothelioma, renal cell carcinoma, certain types of colorectal cancer, esophageal cancer, non-small cell lung cancer and hepatocellular carcinoma.[7,8] Sandoz is the leading biosimilar provider globally and has recently moved up to third position in the US, with a strategic ambition to occupy the leading position in that market.[9] The Company’s industry-leading biosimilars pipeline comprises 28 molecules, complemented by around 450 generic pipeline medicines to support its goal of sustainable and broadly-based long-term growth. The marketed biosimilar oncology portfolio includes Rixathon®, Zarzio®, Ziextenzo®, and Binocrit®. This year, Sandoz expects to launch its biosimilars Wyost®/Jubbonti® (denosumab) in the US in the second quarter and in Europe in the fourth quarter. * Yervoy® is a registered trademark of Bristol-Myers Squibb (US) ** Opdivo® is a registered trademark of Bristol-Myers Squibb (US) REFERENCES 1. Loss-of-exclusivity (LoE) dates based on IP databases; originator-sales data at LoE-1 from internal analysis and Evaluate Pharma [November 2024] 2. Decisions Resource Group (DRG) database of total treated population with Yervoy® (G7 markets) [accessed April 2025] 3. Cancer Today [accessed March 2025] 4. Yervoy® US Prescribing Information [accessed March 2025] 5. Yervoy® EMEA Summary of Product Characteristics [accessed March 2025] 6. Definition of Yervoy ® – NCI Dictionary of Cancer Terms – NCI [accessed March 2025] 7. Opdivo® US: Prescribing Information [accessed March 2025] 8. Opdivo® EMEA Summary of Product Characteristics [accessed March 2025] 9. IQVIA [download February 2025] ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion. SOURCE: Sandoz

引进/卖出上市批准生物类似药

2025-04-30

·GlobeNewswire-Health Care

Sandoz reports Q1 2025 net sales in line with company expectations; full-year guidance confirmed

Ad-hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Q1 2025 net sales of USD 2,480 million up by 3% in constant currencies (cc); stable in USDup by 5%[1] at a comparable growth rate (CGR), when adjusted for impact of 2024 acquisition of US biosimilar Cimerli® (ranibizumab) and 2024 divestment of China businessten largest-selling medicines grew by combined 4% and represented 33% of net sales Europe net sales grew by 7%[1]. International declined by 2%[1] and increased by 2% when adjusted for China divestment. Net sales in North America grew by 1%[1] and, adjusted for Cimerli acquisition, by 3%Anticipated biosimilar launches primarily weighted to second half of year. Launches include Wyost®/Jubbonti® (denosumab) in Europe and US, Tyruko® (natalizumab) in US[2] and Afqlir® (aflibercept) in EuropeFavorable moves towards regulatory streamlining of biosimilar development reflected in decision to minimize pembrolizumab Phase III trialFull-year impact of US government’s confirmed recent tariffs within guidanceFull-year 2025 guidance confirmed: mid single-digit net-sales growth[1] and core EBITDA margin of around 21% Basel, April 30, 2025 – Sandoz (SIX: SDZ / OTCQX: SDZNY), the global leader in generic and biosimilar medicines, today presents its net-sales update for the first quarter of 2025. Richard Saynor, Chief Executive Officer of Sandoz, commented: “With Q1 sales in line with our expectations, we have now delivered fourteen consecutive quarters of top-line growth. This reconfirms our growing track record of execution and performance, driven by commercial excellence and an expanding biosimilar pipeline and portfolio, underpinned by our generics base. I’m looking forward to additional growth in the second quarter and further progress this year as we launch more biosimilar medicines. “With our business continuing to grow, we are confident of delivering more affordable medicines for patients and savings for society, while producing sustainable growth in sales, profitability and cash generation. It is the powerful combination of delivery and pioneering access for patients that makes us proud to be part of the Sandoz growth journey.” FULL-YEAR 2025 GUIDANCE The Company expects further major biosimilar launches later this year, while price erosion is expected to return to normalised levels of a low to mid-single-digit percentage. Sandoz anticipates core EBITDA-margin expansion to reflect the mix of sales, simplification of the external network and the ongoing transformation program. As a result, the Company continues to expect: FY 2025 net sales to grow by a mid single-digit percentage[3] a core EBITDA margin in FY 2025 of around 21% This guidance excludes any impacts of unforeseen events or unconfirmed developments, such as significant further potential trade tariffs emanating from the US government. FIRST-QUARTER NET SALES Net sales for the first quarter amounted to USD 2,480 million, representing growth of 3%[3]. Volume contributed six percentage points of growth, partly offset by price erosion of three percentage points. Q1 2025% of Net SalesQ1 2024 % changeUSD m USD m USDccCGR[3] Generics1,809731,869 -302Biosimilars67127623 81114Net Sales2,4801002,492 035 Generics overviewNet sales for the first quarter were USD 1,809 million, reflecting a stable performance[3] (+2% on a CGR basis). Generics represented 73% of total net sales (Q1 2024: 75%). Europe sales of generics grew in the first quarter, driven by the effect of launches in 2024. International net sales declined, with the impact from the divested China business outweighing growth in other markets. In North America, generics’ net-sales growth benefitted from the successful recent launch of paclitaxel. Biosimilars overviewNet sales for the first quarter were USD 671 million, reflecting growth of 11%[3] (+14% on a CGR basis). Biosimilars represented 27% of total net sales (Q1 2024: 25%). Strong Europe biosimilars’ net-sales growth benefitted from a number of good performances, including Hyrimoz® (adalimumab) and recently launched Pyzchiva® (ustekinumab), while International biosimilar net sales also saw a strong contribution from Omnitrope® (somatropin). North America biosimilar net sales declined, reflecting the withdrawal of Cimerli during the quarter; excluding the impact of the 2024 acquisition Cimerli, North America biosimilar net sales increased. Net sales by region Q1 2025% of Net SalesQ1 2024 % changeUSD m USD m USDccCGR[4] Europe1,372551,326 377International59024642 -8-22North America51821524 -113Net Sales2,4801002,492 035 Europe overviewNet sales for the first quarter amounted to USD 1,372 million, reflecting growth of 7%[4]. Europe net sales of generics grew in the first quarter, with higher growth in biosimilars primarily a result of recent launches, including Pyzchiva. International overviewNet sales for the first quarter amounted to USD 590 million, reflecting a decline of 2%[4]. Excluding the impact of the divestment of the China business, growth amounted to 2%[4]. Pricing increased in both generics and biosimilars during the quarter, with strong biosimilar net sales partly a result of the continued good performance from Omnitrope. North America overviewNet sales for the first quarter amounted to USD 518 million, reflecting growth of 1%[4]. Excluding the impact of the withdrawal of Cimerli, growth amounted to 3%[4]. A good performance from generics was driven by the successful recent launch of paclitaxel, as well as continued strong growth in Canada. Biosimilar net-sales growth would have been positive when excluding the impact of the 2024 acquisition of Cimerli. Price erosion was driven by reduced Cimerli and private-label adalimumab pricing. US TARIFFS The only tariffs applicable to the Company, as part of recent implementation from the US government, is a total 20% China tariff, implemented on March 4, 2025, and a tariff on any medicines coming from Canada but outside the scope of the United States-Mexico-Canada Agreement. These impacts have been incorporated within full-year guidance. The Sandoz manufacturing footprint consists of 15 sites, including 11 in Europe and one in the US, from which the latter does not export to Europe. US first-quarter net sales represented less than one-fifth of total net Q1 sales. REGULATORY STREAMLINING: BIOSIMILARS Reflecting encouraging and favourable developments, Sandoz has decided to minimize its ongoing Phase III trial in patients with untreated metastatic non-squamous non-small cell lung cancer for the proposed biosimilar, pembrolizumab. The ongoing Phase I pharmacokinetic trial is continuing as planned. This decision was partly based on communications with the US FDA, as well as a reflection paper published by the European Medicines Agency. The Company is assessing implications, including for its wider biosimilars pipeline. In April 2025, Sandoz announced the filing of an antitrust lawsuit in the US against Amgen, Inc. (Amgen), for extending and entrenching the dominant market position of Enbrel®[5] (etanercept), first approved by the US FDA in 1998. Sandoz alleges that Amgen blocked competition from more cost-effective biosimilar competitors, including Sandoz etanercept biosimilar, Erelzi®[6] (etanercept-szzs), by unlawfully purchasing and using certain patent rights to entrench its position in the market. KEY LINKS A conference call and webcast for investors and analysts will begin today at 9am CET. Details can be found here, with the accompanying presentation here. CALENDAR The Company intends to publish its half-year results on August 7, 2025. [1] In constant currencies (cc).[2] Subject to FDA approval of John Cunningham virus assay.[3] In constant currencies (cc).[4] In constant currencies (cc).[5] Enbrel® is a registered trademark of Amgen, Inc.[6] Erelzi® is a registered trademark of Sandoz, Inc. CONTACTS Media Relations contactsInvestor Relations contactsglobal.mediarelations@sandoz.cominvestor.relations@sandoz.comAlex Kalomparis+41 79 279 02 85Craig Marks+44 7818 942 383Joerg E. Allgaeuer+49 171 838 4838Tamara Hackl+41 79 790 52 17Danja Spring+41 79 156 74 88Rupreet Sandhu+41 79 410 54 72 DISCLAIMER This media release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. This media release includes non-IFRS financial measures as defined by Sandoz. An explanation of non-IFRS measures can be found in the Supplementary financial information of the latest Integrated Annual Report. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure more than 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion. APPENDIX QUARTERLY NET SALES The Company intends to provide the net-sales performance by region by generics/biosimilars at each half-year and full-year results. FY 2024 Q1 2024% change Q2 2024% change Q3 2024% change Q4 2024% change USD mUSD cc USD mUSDcc USD mUSDcc USD mUSDccGenerics 1,86901 1,835-11 1,85434 1,94614Biosimilars6232121 7203537 7413637 7692325Net Sales 2,49256 2,55579 2,5951112 2,71579 Q1 2024% change Q2 2024% change Q3 2024% change Q4 2024% change USD mUSD cc USD mUSDcc USD mUSDcc USD mUSDccEurope 1,32642 1,30823 1,3621312 1,36778International642412 62759 63528 65306North America52466 6202223 5981718 6951314Net Sales 2,49256 2,55579 2,5951112 2,71579 Attachment Media release_Q1 2025 sales.pdf

生物类似药上市批准临床3期临床1期并购

100 项与地舒单抗生物类似药 (Novartis) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	M05BX04	DB06643

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
恶性肿瘤体液性高钙血症	澳大利亚	Sandoz Pty Ltd.	2024-08-23
多发性骨髓瘤	澳大利亚	Sandoz Pty Ltd.	2024-08-23
骨癌	欧盟	Sandoz GmbH	2024-05-17
骨癌	冰岛	Sandoz GmbH	2024-05-17
骨癌	列支敦士登	Sandoz GmbH	2024-05-17
骨癌	挪威	Sandoz GmbH	2024-05-17
代谢性骨病	欧盟	Sandoz GmbH	2024-05-16
代谢性骨病	冰岛	Sandoz GmbH	2024-05-16
代谢性骨病	列支敦士登	Sandoz GmbH	2024-05-16
代谢性骨病	挪威	Sandoz GmbH	2024-05-16
骨病	美国	Sandoz, Inc.	2024-03-05
骨转移癌	美国	Sandoz, Inc.	2024-03-05
骨巨细胞瘤	美国	Sandoz, Inc.	2024-03-05
糖皮质激素诱导的骨质疏松症	美国	Sandoz, Inc.	2024-03-05
高钙血症	美国	Sandoz, Inc.	2024-03-05
骨质疏松症	美国	Sandoz, Inc.	2024-03-05
绝经期后骨质疏松	美国	Sandoz, Inc.	2024-03-05
骨质疏松性骨折	美国	Sandoz, Inc.	2024-03-05

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
骨折	申请上市	美国	Sandoz International GmbH	2023-02-06

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03974100 (ROSALIA, WCO_IOF_ESCEO2023)	临床3期	绝经期后骨质疏松	527	GP2411	網淵鹹繭夢糧淵鏇憲夢(夢遞簾簾憲醖構網鏇齋) = 鹽網壓獵襯築鏇餘淵積齋製醖遞鹽鹽蓋獵製蓋 (蓋簾鑰衊衊餘齋壓觸襯 ) 更多	积极	2023-05-04
				Reference Denosumab	網淵鹹繭夢糧淵鏇憲夢(夢遞簾簾憲醖構網鏇齋) = 鑰範憲獵鹹糧遞夢夢壓齋製醖遞鹽鹽蓋獵製蓋 (蓋簾鑰衊衊餘齋壓觸襯 ) 更多
NCT03974100 (ROSALIA, CTgov)	临床3期	绝经期后骨质疏松	527	GP2411	積網鹽製築網衊構構廠(餘廠積壓齋網廠淵顧鏇) = 鬱壓鏇鬱鏇鑰餘襯鑰願糧醖製積積繭膚築膚壓 (鬱網網願齋鏇膚襯鏇衊, 0.2634) 更多	-	2023-03-08
NCT03974100 (GlobeNewswire) 人工标引	临床3期	骨质疏松症	-	Denosumab-GP2411	願簾鏇淵鹽憲鏇顧積簾(壓壓簾鹽艱艱範鬱觸廠) = ROSALIA study met primary endpoints, confirming proposed biosimilar denosumab matches reference product in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in postmenopausal women with osteoporosis 選鑰積壓憲製願衊鹹觸 (鬱廠鬱糧選襯願夢艱廠 )	相似	2022-09-19
				Denosumab