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

山德士有限公司

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100 项与地舒单抗生物类似药 (Novartis) 相关的临床结果

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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 ; Kivitz, Alan ; Krivtsova, Natalia

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）

2024-10-30

·GlobeNewswire-Health Care

Sandoz reports third-quarter and nine-month 2024 sales

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Strong third-quarter biosimilars growth of 37% in constant currencies from existing portfolio and recent launchesGenerics growth acceleration driven by EuropeThird-quarter net sales¹ of USD 2.6 billion, up 12% in constant currencies (up 11% in USD)Nine-month net sales of USD 7.6 billion, up 9% in constant currencies (up 8% in USD)Net sales growth guidance increased to high-single digit in constant currencies (from mid- to high-single digit) and core EBITDA margin² guidance of around 20% confirmed Basel, October 30, 2024 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced net sales for the third quarter and nine months ended September 30, 2024. For the third quarter, net sales were USD 2.6 billion, an increase of 12% in constant currencies compared to the same quarter of the prior year. For the first nine months of 2024, net sales were USD 7.6 billion, an increase of 9% in constant currencies compared to the prior year. Richard Saynor, Chief Executive Officer of Sandoz, said: “We remain focused on execution, meeting key milestones in our biosimilars business and progressing on our journey as a standalone company. In recent months, we received approval for Pyzchiva® and Enzeevu™ in the US, launched Pyzchiva® in Europe and see continued strong uptake of Hyrimoz® in the US. “Net sales growth was achieved across generics and biosimilars, with generics accelerating in the third quarter and strong double-digit biosimilars growth in both the third quarter and first nine months. Additionally, all three regions contributed to this strong performance. We expect momentum in our business to continue, driving margin expansion through favorable product mix and leveraging our cost base. We have further advanced on our path to simplifying our business, including progression on the transformation program we launched earlier this year.” THIRD-QUARTER AND NINE-MONTH SALES Net sales for the third quarter were USD 2.6 billion, up 12% in constant currencies, compared to the third quarter of 2023. Volume contributed 13 percentage points of growth. This was partially offset by price erosion of 1 percentage point. Biosimilars were the key driver of growth in the quarter, while generics experienced solid demand. Growth accelerated in both businesses. Net sales for the first nine months of 2024 were USD 7.6 billion, up 9% in constant currencies compared to prior year. Volume contributed 11 percentage points of growth. This was partially offset by price erosion of 2 percentage points. The growth was primarily driven by biosimilars, with strong demand for both the base business and new in-market organic and acquired products in the US. Net sales by business Q3 2024Q3 2023 Change % 9M 20249M 2023 Change %USD millions unless indicated otherwise USDcc* USDcc*Generics 1 8541 794 34 5 5585 512 12Biosimilars 741 543 3637 2 0841 592 3132Net sales to third parties 2 5952 337 1112 7 6427 104 89 *constant currencies Generics overviewNet sales for the third quarter were USD 1.9 billion, up 4% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 5.6 billion, up 2% in constant currencies versus prior year. Growth in the Europe region accelerated in the third quarter, mainly driven by recent launches. The momentum continued in the International region, aided by demand for the antifungal agent Mycamine® and favorable pricing dynamics, partly offset by the divestment of the Chinese business. North America declined due to timing of new launches in the US. Biosimilars overviewNet sales for the third quarter were USD 741 million, up 37% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 2.1 billion, up 32% in constant currencies versus prior year. The strong double-digit biosimilars growth reflects the uptake of Hyrimoz® (adalimumab) in the US, the acquisition of Cimerli® (ranibizumab), the continued strong demand for our first-ever biosimilar, Omnitrope® (somatropin), and the launches of Tyruko® (natalizumab) and Pyzchiva® (ustekinumab) in Europe. Net sales by region Q3 2024Q3 2023 Change % 9M 20249M 2023 Change %USD millions unless indicated otherwise USDcc USDccEurope 1 3621 204 1312 3 9963 751 76North America 598 510 1718 1 7421 514 1515International 635 623 28 1 9041 839 49Net sales to third parties 2 5952 337 1112 7 6427 104 89 Europe overviewNet sales for the third quarter were USD 1.4 billion, up 12% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 4.0 billion, up 6% in constant currencies versus prior year. Strong growth in biosimilars continues, led by demand for Omnitrope® and the contribution from the recent launches of Tyruko® and Pyzchiva®. Generics momentum accelerated in the third quarter, driven by recent launches and the lapping of the strong prior-year comparison in the first half. North America overviewNet sales for the third quarter were USD 598 million, up 18% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 1.7 billion, up 15% in constant currencies versus prior year. Growth was driven by the ongoing uptake of Hyrimoz® in the US, the acquisition of Cimerli®, share gain of Omnitrope® in the US and the launch of Wyost®/Jubbonti® in Canada. This was partly offset by a decline in generics sales due to the timing of new launches in the US. International overviewNet sales for the third quarter were USD 635 million, up 8% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 1.9 billion, up 9% in constant currencies versus prior year. This was primarily a result of strong volume growth across both generics and biosimilars, contribution from the acquisition of Mycamine® in the prior year, favorable price dynamics and recent launches, partly offset by the divestment of the Chinese business in the second quarter. GUIDANCE 2024 On the back of strong momentum in its biosimilars business and solid generics demand, the company is increasing its full-year 2024 net sales guidance to high-single digit growth in constant currencies versus prior year (from mid- to high-single digit) and is confirming its core EBITDA margin guidance of around 20%. THIRD-QUARTER STRATEGIC MILESTONES Sandoz continued to execute on its strategy and passed additional milestones in its biosimilars portfolio. On July 1, the company announced the US FDA approval of biosimilar Pyzchiva® for all indications of the reference medicine. The company intends to launch Pyzchiva® in the US among the first wave of ustekinumab biosimilars in February 2025. On July 25, Sandoz announced the launch of biosimilar Pyzchiva® across Europe to treat chronic inflammatory diseases. Pyzchiva® was the first biosimilar to launch in Europe with all reference medicine strengths, including an initiation dose for Crohn’s disease. On August 12, Sandoz received FDA approval for Enzeevu™ to treat neovascular age-related macular degeneration. This approval further enhances the company’s leading US ophthalmology portfolio and increases access for patients. Launch timing will be dependent on several factors, including the progress and outcome of pending or potential litigation or any potential settlements. KEY LINKS Webcast – Live at 9am CET Analyst call presentationAnalyst consensus 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 Half-Year Report 2024. 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 800 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,500 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 2023, Sandoz recorded net sales of USD 9.6 billion. CONTACTS Global Media Relations contacts Investor Relations contactsGlobal.MediaRelations@sandoz.comInvestor.Relations@sandoz.comSteffen Kurzawa+41 79 800 8501Laurent de Weck+41 79 795 7364Joerg E. Allgaeuer+49 171 838 4838Tamara Hackl+41 79 790 5217 SUPPORTING FINANCIAL INFORMATION Quarterly net sales 2024 Q1 2024Change % Q2 2024Change % Q3 2024Change %USD millions unless indicated otherwise USDcc USDcc USDccGenerics 1 86901 1 835-11 1 85434Biosimilars 6232121 7203537 7413637Net sales to third parties 2 49256 2 55579 2 5951112 Q1 2024Change % Q2 2024Change % Q3 2024Change %USD millions unless indicated otherwise USDcc USDcc USDcc Europe 1 32642 1 30823 1 3621312North America 52466 6202223 5981718International 642412 62759 63528Net sales to third parties 2 49256 2 55579 2 5951112 2023 Q1 2023Change % Q2 2023Change % Q3 2023Change % Q4 2023Change %USD millions unless indicated otherwise USDcc* USDcc* USDcc* USDcc* Generics 1 86826 1 85046 1 79454 1 92066Biosimilars 5161117 5331314 54374 6232926Net sales to third parties 2 38449 2 38358 2 33764 2 5431110 Q1 2023Change % Q2 2023Change % Q3 2023Change % Q4 2023Change %USD millions unless indicated otherwise USDcc* USDcc* USDcc* USDcc* Europe 1 2701016 1 2771412 1 204113 1 272104North America 496-5-3 508-4-2 510-4-3 6152020International 618-14 598-38 623312 656414Net sales to third parties 2 38449 2 38358 2 33764 2 5431110 ¹ Net sales in this document refer systematically to net sales to third parties. In the first nine months of 2023, third-party sales excluded sales to our former parent. Post spin-off, sales to our former parent are reported as third-party sales.² An explanation of non-IFRS measures can be found in the Supplementary financial information of the Half-Year Report 2024 Attachment 241030_Q3 and 9M Sales 2024_ Media Release.pdf

上市批准生物类似药并购

2024-08-09

·FiercePharma

Sandoz lifts guidance after Humira biosimilar drives another quarter of sales growth

Novartis spinout Sandoz garnered $2.6 billion in second-quarter product sales. After the performance, the company raised its sales guidance for the year. After taking a market share lead in the crowded Humira biosimilar space and with other key launches in the works, Novartis spinout Sandoz is raising its full-year sales guidance.Sandoz previously communicated that it expects 2024 sales growth to reach mid-single-digit percentages. Now, after reporting second-quarter results, the company said it expects mid- to high-single-digit growth for the year.The company collected $2.6 billion in net sales during the second quarter, representing 9% sales growth compared to the same period last year.The boost was driven by the drugmaker’s clutch of biosimilars, which together saw an "exceptional" growth rate of 29%, CEO Richard Saynor said on Sandoz’s recent earnings call. Sandoz does not report individual product sales. Within the drugmaker’s biosimilar franchise, Humira copycat Hyrimoz is the standout. The med holds an 81% market share in the crowded space of biosimilar competitors to AbbVie’s popular immunology drug and has the “broadest payer coverage” of them all, according to a Sandoz investor presentation (PDF).Sandoz took on a unique strategy with its Hyrimoz, launching both a branded and an unbranded version and linking with CVS Health’s biosimilar subsidiary Cordavis on a co-labeled version. Earlier this year, CVS Caremark pulled AbbVie’s branded Humira from its national commercial formularies, in turn sending Hyrimoz prescriptions skyrocketing.Outside of Hyrimoz, the biosimilar maker has a number of potentially big launches in the works. Just recently, Sandoz launched its version of Johnson & Johnson’s Stelara in Europe. That biosim is expected to hit the U.S. in February 2025 in accordance with a J&J settlement. After that, the company looks to launch its copies of Amgen’s bone drugs Xgeva and Prolia, which will be branded as Wyost and Jubbonti, respectively, in the second quarter of next year. Regeneron and Bayer’s ophthalmology powerhouse Eylea is another potential victim of Sandoz's biosimilar ambitions. The companies are engaged in patent litigation right now, but Saynor said the company's Eylea biosimilar should arrive in the coming years.In the meantime, Sandoz can also still rely on its aging Omnitrope to buoy sales alongside Hyrimoz. That drug, a biosimilar to Pfizer’s human growth hormone Genotropin, predates even the FDA’s biosimilar approval pathway with its 2006 nod. Since then, Omnitrope has overtaken Pfizer’s original as the market leader, and its sales were still on the rise in the second quarter of 2024.It hasn’t yet been a year since Sandoz spun out of Novartis, but the company is already hard at work initiating a “multi-year transformation program” to simplify its organizational structure. Under that program, the company expects savings of $50 million in this year's second half. By 2026, Sandoz is targeting annual savings of $200 million.

生物类似药专利侵权专利到期

2024-06-02

·蒲公英Ouryao

Bio·News | 生物医药行业一周头条（05.23-05.29）

yuanBio·News药监资讯1、国家药监局 | 11月24日起、分析方法开发/验证适用ICH2024年5月28日，国家药监局发布公告，为推动药品注册技术标准与国际接轨，经研究，自2024年11月24日开始的相关研究（以试验记录时间点为准），均适用Q2（R2）/Q14指导原则。（相关阅读点击查看）（来源：国家药品监督管理局、蒲公英Ouryao）2、CDE | 征求意见：关爱计划2024年5月24日，国家药监局审评中心发布了公开征求《以患者为中心的罕见疾病药物研发试点工作计划（“关爱计划”）》申报指南和实施框架意见的通知，征求意见时限为自发布之日起1个月。（相关阅读点击查看）（来源：国家药品监督管理局药品审评中心、蒲公英Ouryao）受理情况CDE受理情况2024年5月23日-5月29日期间，中国国家药监局药品审评中心（CDE）共受理药品申请292个，其中生物制品48个（新药21个和进口6个，见下图）。（来源：国家药品监督管理局药品审评中心）企业动态1、恒瑞医药 | Trop2 ADC创新药SHR-A1921拟纳入突破性疗法2024年5月26日，恒瑞官微发布消息称，其自主研发的TROP-2抗体偶联药物（antibody-drug-conjugate, ADC）注射用SHR-A1921用于治疗铂耐药复发上皮性卵巢癌、输卵管癌或原发性腹膜癌适应症被国家药品监督管理局药品审评中心拟纳入突破性治疗品种公示名单。今年3月，注射用SHR-A1921该适应症获得美国食品和药物监督管理局（FDA）授予快速通道资格（fast track designation, FTD）。目前，国内外尚未有同靶点药物获批卵巢癌相关的适应症。（来源：国家药品监督管理局药品审评中心）2、博安生物 | 地舒单抗注射液获批上市，度拉糖肽生物类似药申报上市2024年5月27日，博安生物宣布，其自主开发的肿瘤领域地舒单抗注射液（120mg）——博洛加®正式获得中国国家药品监督管理局的上市批准，用于治疗不可手术切除或者手术切除可能导致严重功能障碍的骨巨细胞瘤，包括成人和骨骼发育成熟（定义为至少1处成熟长骨且体重≥45 kg）的青少年患者。与此同时，博洛加®用于实体肿瘤骨转移和多发性骨髓瘤适应症的上市申请工作也在推进中。中国市场以外，博安生物亦在欧洲、美国、日本开展博洛加®的国际多中心Ⅲ期临床试验，并计划在全球更多国家和地区上市该产品。2024年5月28日，博安生物宣布，其自主研发的度拉糖肽注射液生物类似药（BA5101）的上市申请（BLA）已获得中国国家药监局药品审评中心（CDE）受理，用于成人2型糖尿病患者的血糖控制。BA5101是目前国内首个提交上市申请的度易达®（英文名：Trulicity®）的生物类似药，该产品的国际注册和临床也在同步推进。（来源：博安生物官微）3、山德士 | 两款地舒单抗生物类似药在欧盟获批2024年5月22日，山德士(Sandoz)宣布，欧盟委员会（EC）已批准该公司地舒单抗生物类似药Wyost和Jubbonti上市，这两款药物分别是安进的Xgeva和Prolia在欧洲的首个也是目前唯一获批的生物类似药版本。Wyost被批准用于癌症相关骨病的治疗，Jubbonti被批准用于治疗骨质疏松症。山德士预计从2025年11月开始销售这两款药物。山德士在生物类似药领域具有全球领先的优势，其管线中共有24款生物类似药，可以说是目前生物类似药领域当之无愧的王者。据财报披露，山德士2023年生物类似药业务收入高达22.15亿美元。5月初公布的第一季度报中，生物类似药业务更是增长了21%。（来源：Sandoz官网、医药经济人）4、赛诺菲 | CD38单抗新适应症获FDA受理并获优先审评资格2024年5月22日，赛诺菲CD38单抗艾沙妥昔单抗新适应症上市申请获CDE受理，其注册分类为2.2，意味着该项适应症境内外均未获批。结合此前赛诺菲公布的III期IMROZ试验结果，推测该项适应症为一线治疗不符合移植条件的多发性骨髓瘤（MM）患者。2020年3月，艾沙妥昔单抗首次获FDA批准上市，联合泊马度胺和地塞米松治疗既往至少接受过2线以上疗法（包括来那度胺和一种蛋白酶体抑制剂）的复发性难治性多发性骨髓瘤成人患者。2021年3月，艾沙妥昔单抗获FDA批准扩展新适应症，联合卡非佐米和地塞米松用于既往接受过1-3线治疗的复发性或难治性多发性骨髓瘤成人患者。2023年2月，依托“港澳药械通”政策，艾沙妥昔单抗落地中国粤港澳大湾区。2023年12月，艾沙妥昔单抗首次在华申报上市。（来源：Sanofi官网、医药经济人）5、复宏汉霖 | 秘鲁获批，汉利康出海“首战”高捷2024年5月27日，复宏汉霖官微发布消息称，近期，其自主开发和生产的汉利康®（利妥昔单抗）正式获得秘鲁药监局（Dirección General de Medicamentos, Insumos y Drogas, “DIGEMID”）批准上市，商品名为AUDEXA®。汉利康®成为继汉曲优®和汉斯状®后，复宏汉霖第三款海外获批上市的自主研发和生产的产品。作为中国首个生物类似药，汉利康®自2019年获批上市以来已惠及超25万名中国患者。复宏汉霖第三款实现海外获批上市自研产品，锚定全球化战略汉利康®首次海外获批，加速惠及新兴市场国家中国首款生物类似药，已惠及逾25万中国患者（来源：复宏汉霖官微）END编辑：芝麻核桃声明：本文仅代表作者个人观点，不代表任何组织及本公众号立场，如有不当之处，敬请指正。如需转载，请注明作者及来源：蒲公英Biopharma。热门活动请关注/2024年6月6日上海生物制药创新发展高管沙龙点击查看活动详情/2024年6月13-14日上海制药首席项目官人才培养项目点击查看活动详情/2024年6月27-28日南京2024药品原辅包技术发展峰会点击查看活动详情

突破性疗法临床3期抗体药物偶联物快速通道优先审批

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,

后查看更多信息

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

分期

评价

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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 (CTgov)	临床3期	绝经期后骨质疏松	527	GP2411	鹽鑰壓遞鹹廠顧觸觸範(範鬱構獵襯網選觸願壓) = 網齋壓餘艱夢範遞醖鏇網窪鑰製糧鬱構範衊製 (淵鹹糧衊觸築遞築構範, 遞築製鬱簾繭淵範衊夢 ~ 壓齋願醖繭觸餘選簾鏇) 更多	-	2023-03-08
NCT03974100 (GlobeNewswire) 人工标引	临床3期	骨质疏松症	-	Denosumab-GP2411	襯積獵蓋齋壓積範構網(淵簾壓窪廠獵鏇壓遞簾) = 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 廠鬱鏇齋鹽醖憲鹹築淵 (鏇蓋鹹糧製顧蓋齋觸鹽 )	相似	2022-09-19
NCT03974100 (GlobeNewswire) 人工标引	临床3期	骨质疏松症	-	Denosumab		相似	2022-09-19