A Randomized, Open Label Multicenter Trial to Investigate the Efficacy of a Treat-to-target (T2T) Treatment Strategy With Secukinumab (AIN457) as a First-line Biologic Compared to a Standard-of-care (SOC) Treatment Over 36 Weeks in Patients With Active Axial Spondyloarthritis (axSpA)

This is a randomized, parallel-group, open-label, multicenter study of patients with active axSpA. The aim is to demonstrate that the efficacy of a Treat-to-Target (T2T) approach (with secukinumab as first-line biologic) is superior to a Standard-Of-Care (SOC) approach in terms of achieving strong clinical efficacy in patients with active axial Spondyloarthritis (axSpA) who are naïve to biological therapy and who have had an inadequate response to non-steroidal anti-inflammatory drugs. The study will include an 8-week Screening period, a 36-week treatment period according to previous randomization, and a safety follow-up period of 20 weeks. The primary endpoint is the percentage of patients achieving an Assessment in SpondyloArthritis international Society response 40 (ASAS40) at Week 24.

开始日期2019-06-04

申办/合作机构

Novartis Pharmaceuticals Corp.

NCT02744755

/ Completed临床3期

A Randomized, Double-blind, Parallel-group, Multicenter Study to Demonstrate Similar Efficacy and to Compare Safety and Immunogenicity of GP2017 and Humira® in Patients With Moderate to Severe Active Rheumatoid Arthritis

Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis

开始日期2016-03-31

申办/合作机构

山德士有限公司

[+1]

NCT02706704

/ Recruiting临床2期IIT

Efficacy of Intravitreal Adalimumab Compared to Subcutaneous Adalimumab in Patients With Non-infectious Uveitis

The objective of this study is to compare and evaluate the efficacy of subcutaneous (40mg) adalimumab biweekly injections to intravitreal adalimumab (1.5 mg/ 0.03 mL) administration, given at zero, 2 weeks then every four weeks, in subjects with active non-infectious intermediate-, posterior-, or pan-uveitis.

开始日期2016-02-01

申办/合作机构

American University of Beirut Medical Center

100 项与阿达木单抗生物类似药(Sandoz) 相关的临床结果

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100 项与阿达木单抗生物类似药(Sandoz) 相关的转化医学

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100 项与阿达木单抗生物类似药(Sandoz) 相关的专利（医药）

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项与阿达木单抗生物类似药(Sandoz) 相关的文献（医药）

2025-01-01·Journal of Pediatric Health Care

Biosimilars Versus Originators in Children With Juvenile Idiopathic Arthritis: A Real-World Experience

Article

作者: Di Sessa, Anna ; Gicchino, Maria Francesca ; Miraglia del Giudice, Emanuele ; Olivieri, Alma Nunzia ; Capasso, Giusy ; Amodio, Alessia

INTRODUCTION:

We aimed to evaluate the efficacy, safety, and immunogenicity profile of Etanercept (ETA) and Adalimumab (ADA) biosimilars (BIOs) compared to their originators in children with juvenile idiopathic arthritis (JIA).

METHOD:

Eighty-one JIA children treated with ETA or ADA originators or BIOs were examined at baseline (T0) and after 3- (T1), 6- (T2), 12- (T3), and 24-(T4) months after starting treatment.

RESULTS:

Lower Juvenile Arthritis Disease Activity Score 10 (JADAS-10) scores were reported at T1, T2, T3, and T4 in JIA children treated with BIOs than originators (all p < 0.05). At T1 and T3, anti-drugs antibodies levels were lower in children receiving BIOs than originators (p = 0.04 and p = 0.0007, respectively), even after adjustments (both p < 0.05). Relapses were lower for BIOs compared to originators (p < 0.001). Safety profile was comparable between the groups (p > 0.05).

DISCUSSION:

A better overall profile of BIOs than originators was demonstrated in JIA children, but larger confirmatory studies are needed.

2024-12-01·EXPERT OPINION ON BIOLOGICAL THERAPY

Comparing anti-drug antibody signal-to-noise ratios to assess immunogenicity and interchangeability in adalimumab biosimilar studies

Article

作者: Blauvelt, Andrew ; Cohen, Hillel P. ; Torella, Claudia ; Wang, Qingfeng ; Brückmann, Ines ; von Richter, Oliver ; Guerrieri, Davide ; Poetzl, Johann ; Fan, Jamie ; Lemke, Lena ; Horvat, Matej

BACKGROUND:

To support an interchangeability designation for Sandoz adalimumab biosimilar (GP2017), antidrug antibody (ADA) signal-to-noise (S/N) ratios were assessed in the GP2017 ADACCESS trial to directly assess potential changes in immunogenicity.

RESEARCH DESIGN AND METHODS:

ADACCESS was a 51-week trial in patients with moderate-to-severe plaque psoriasis that included patients treated continuously with reference adalimumab (cH), and patients who experienced four switches between reference adalimumab and GP2017 (H2H). ADAs were measured every 6 weeks during the switching phase using an electrochemiluminescence assay. A non-parametric analysis was performed to estimate the 90% confidence interval (CI) of the median of difference in ADA S/N ratios between the cH and H2H treatment groups at week 41. If the 90% CI was within the margin of -0.16 to 0.16 (representing assay noise), this was considered a non-clinically meaningful difference in immunogenicity.

RESULTS:

The 90% CIs of the median of difference in ADA S/N ratios between the two treatment groups were within the defined margin of -0.16 to 0.16 at week 41, and at all other time points. Efficacy and safety data were also similar between the treatment groups.

CONCLUSION:

Analysis of ADA S/N ratios showed no increase in immunogenicity following up to four switches between reference adalimumab and GP2017.

TRIAL REGISTRATION:

NCT02016105.

2024-09-01·Current rheumatology reviews

Development of Morphea Following Treatment with an ADA Biosimilar: A Case Report

Article

作者: Voulgari, Paraskevi V ; Drosos, Alexandros A ; Pelechas, Eleftherios ; Venetsanopoulou, Aliki I ; Mavridou, Konstantina

Background::

Tumor necrosis factor alpha (TNFα) is a pivotal cytokine involved in the pathogenesis of certain inflammatory diseases, such as rheumatoid arthritis (RA), spondyloarthropathies, and inflammatory bowel diseases. In the last two decades, TNFα inhibitors (TNFi) have revolutionized the treatment and outcome of the above disorders. However, the use of TNFi has been associated with the development of many autoimmune phenomena and paradoxical skin manifestations that may present as the same type of clinical indications for which the TNFi effectively used. Thus, they may display as arthritis, uveitis, colitis, psoriasis, and several other cutaneous clinical manifestations, among them the development of morphea, a localized scleroderma skin lesion.

Case Presentation::

We describe a 58-year-old woman with seronegative RA, refractory to methotrexate, who was treated with ABP-501 (Hefiya), an adalimumab (ADA) biosimilar and developed an oval-shaped, deep skin lesion of approximately 3.5cm in size, affecting the left part of her back compatible with morphea 3 months after the initiation of therapy. ADA biosimilar was discontinued and two months later, she had substantial skin improvement.

Conclusion::

This is the first report of morphea manifestation during TNFi biosimilar since the patient had no other trigger factors for morphea development like trauma and infections. Physicians dealing with patients treated with TNFi biosimilars should be aware of paradoxical skin reactions, among them morphea; thus, close monitoring, a minute and careful clinical examination, and a follow- up check are required.

项与阿达木单抗生物类似药(Sandoz) 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

2024-08-27

·Business Wire

MedImpact Expands Access to Two Humira Biosimilars for New Patients

SAN DIEGO--( BUSINESS WIRE )--MedImpact Healthcare Systems, Inc., the nation’s largest independent provider of health solutions, technology, and pharmacy benefit services, today announced that it is expanding access to Humira biosimilars, Simlandi and adalimumab-adaz, for new patients requiring medication for inflammatory conditions such as Crohn’s disease or rheumatoid arthritis. Patients already taking Humira through their pharmacy benefit can continue to do so, and new patients who have taken one of the two biosimilars but did not see the desired results may switch to Humira. “We are making these biosimilars for Humira available through the pharmacy benefit because we are now, for the first time, satisfied that they meet our stringent standards for clinical interchangeability and lowest net cost,” said Nicole Ellermeier, PharmD, MBA, Vice President Formulary Strategy & Rebate Economics, MedImpact. “And we have designed our approach to give members, providers, and payers flexibility, choices, and confidence.” MedImpact’s approach to biosimilars announced today is consistent with its 35-year tradition of pharmacy and manufacturer neutrality. Members may have their prescriptions filled at any pharmacy for FDA-approved biosimilars, regardless of the manufacturer. This level of flexibility is not universally available in the marketplace. Given the complexity of the manufacturing process and nature of the ingredients, MedImpact is making two biosimilars available to ensure availability in the event of supply chain disruptions. To ensure that clinical considerations take precedence over cost alone, the member copay, deductible, and other factors will be the same for the biosimilars and Humira. This allows member flexibility without incurring any additional out-of-pocket costs. MedImpact continues to monitor the market for biosimilars for several conditions and will to add to its formularies others that meet its clinical, supply chain, and cost requirements. “Expanding access to biosimilars is complex and involves significant clinical and economic implications,” said Arpit Patel, PharmD, Vice President, Trade Relations, MedImpact. “Our guiding principle, however, is straightforward: First, we must provide convenient and affordable access to clinically appropriate medications, followed by ensuring these medications are financially sustainable for patients and payers alike.” About MedImpact Healthcare Systems San Diego-based MedImpact Healthcare Systems, Inc. is the nation’s largest independent health solutions, technology, and pharmacy benefit management provider. For 35 years, MedImpact has helped commercial and government healthcare payers improve member health, manage benefits, and reduce drug costs. To learn more, visit us online , follow us on LinkedIn , or contact us at info@MedImpact.com .

2024-08-12

·Pharmaceutical Technology

FDA approves Sandoz’s Enzeevu as Eylea biosimilar saga continues

The biosimilar references Regeneron and Bayer’s blockbuster ophthalmology asset Eylea (aflibercept). Image credit: Shutterstock / photoJS. The US Food and Drug Administration (FDA) has approved Sandoz ’s Enzeevu (aflibercept-abzv), the drugmaker’s biosimilar for wet age-related macular degeneration (AMD). Available as a 2mg vial kit and pre-filled syringe, the biosimilar– which references Regeneron and Bayer ’s Eylea (aflibercept) – is indicated to improve and maintain visual acuity in patients with the eye disease. Enzeevu joins Biocon Biologics’s Yesafili (aflibercept-jbvf) and Samsung Bioepis’ Opuviz (aflibercept-yszy) in the list of FDA-approved biosimilars to Eylea. Yesafili and Opuviz were both greenlit by the agency as the first biosimilars in May this year. They were both designated as interchangeable products. The FDA has provisionally said Enzeevu would be interchangeable with Eylea as “it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products”, as per a 12 August press release. Interchangeable biosimilars are eligible for a year of market exclusivity if they are the first biosimilar of a given product to receive interchangeable designation, as per the Biologics Price Competition and Innovation Act. It is possible that multiple interchangeable biosimilars could share a period of initial exclusivity if they are approved at the same time. See Also: What’s involved in designing effective lyophilization cycles? Sanofi invests $1.4bn in insulin production in Germany However, how this exclusivity period is exercised was scrutinised when Boehringer Ingelheim , which produces the first interchangeable biosimilar for Humira (adalimumab) called Cyletzo, was in litigation with Pfizer , which also produces an interchangeable biosimilar. The company has said that Enzeevu’s launch will be dependent on the outcome of pending or potential future related litigations, as well as any potential settlements, amongst other factors. Sandoz did not reply to a request from Pharmaceutical Technology to clarify the exclusivity timelines. Biosimilars are not new to the wet AMD treatment space, with the first copycat to Genentech’s Lucentis (ranibizumab) hitting the market in 2021. Sandoz strengthened its ophthalmology portfolio when it spent $170m to acquire Cimerli (ranibizumab-eqrn) – the first interchangeable biosimilar to Lucentis – from Coherus in March this year. Sandoz stated Enzeevu will be a “key biosimilar value driver” as the company expands its ophthalmology presence. Sandoz, which completed its spin-off from Novartis late last year, lifted its 2024 sales guidance earlier this week while reporting Q2 financial results. Propelled by strong sales of the Humira-copycat Hyrimoz, the company notched total sales of $2.6bn for the second quarter. Wet AMD, also known as neovascular AMD, is a leading cause of vision loss, affecting around 1.5 million people aged 40 years and older in the US. Amongst AMD cases, the wet subtype is responsible for 90% of severe vision losses. Similar to Eylea, the biosimilars work by inhibiting vascular endothelial growth factor (VEGF), which prevents abnormal blood vessel growth. Regeneron’s Eylea currently dominates the ophthalmology market, netting $5.89bn in sales last year. However, product revenues were down by 6.3% from the year before due to increased competition from Roche’s wet AMD drug Vabysmo (faricimab) and others. Regeneron has also been locked in various court battles with other companies over alleged patent infringements with their aflibercept biosimilars. Samsung Bioepis’ Opuviz received a preliminary injunction, whilst Biocon was hit with a permanent injunction. Regeneron won a case against Viatris ’s proposed biosimilar in December 2023, citing a patent that protects its drug until 2027. Along with biosimilar introduction, Eylea will also face competition from Vabysmo. Vabysmo, whose patent expires in 2039, reached blockbuster status in only its second year on the market, notching $2.66bn in global sales last year. The biologic is predicted to see revenues of $8.5bn by 2030, according to GlobalData’s Pharma Intelligence Center. GlobalData is the parent company of Pharmaceutical Technology .

上市批准生物类似药专利侵权

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB04	DB00051

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
中间葡萄膜炎	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2022-02-16
后葡萄膜炎	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2022-02-16
白塞氏葡萄膜炎	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2020-06-29
全葡萄膜炎	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2020-06-29
脓疱型银屑病	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2020-06-29
关节炎	澳大利亚	Sandoz Pty Ltd.	2019-03-01
多关节型幼年特发性关节炎	澳大利亚	Sandoz Pty Ltd.	2019-03-01
强直性脊柱炎	欧盟	Sandoz GmbH	2018-07-26
强直性脊柱炎	冰岛	Sandoz GmbH	2018-07-26
强直性脊柱炎	列支敦士登	Sandoz GmbH	2018-07-26
强直性脊柱炎	挪威	Sandoz GmbH	2018-07-26
银屑病关节炎	欧盟	Sandoz GmbH	2018-07-26
银屑病关节炎	冰岛	Sandoz GmbH	2018-07-26
银屑病关节炎	列支敦士登	Sandoz GmbH	2018-07-26
银屑病关节炎	挪威	Sandoz GmbH	2018-07-26
中轴性脊柱关节炎	欧盟	Sandoz GmbH	2018-07-26
中轴性脊柱关节炎	冰岛	Sandoz GmbH	2018-07-26
中轴性脊柱关节炎	列支敦士登	Sandoz GmbH	2018-07-26
中轴性脊柱关节炎	挪威	Sandoz GmbH	2018-07-26
溃疡性结肠炎	欧盟	Sandoz GmbH	2018-07-26

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临床结果

适应症

分期

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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


ACR2021	N/A	银屑病 \| 银屑病关节炎 \| 类风湿关节炎	-	SDZ-ADL (GP2017)	醖餘淵憲壓鬱憲製齋願(憲齋壓鹽鹽鬱願遞餘壓) = At 1-hour post-dose, 96.6% of HV experienced no pain (VAS score, 0-4 mm) 餘餘積壓廠餘鬱獵壓鹹 (築觸膚窪鏇網願蓋憲積 )	积极	2021-11-07
EULAR2021	N/A	银屑病 \| 类风湿关节炎	-	SDZ-ADL (GP2017)	範觸觸淵鑰憲鏇糧鑰膚(醖艱鬱膚憲襯範鏇獵顧) = 夢顧壓壓壓糧簾繭鏇蓋蓋鏇鬱餘願夢網襯壓蓋 (製鏇網淵鏇製製憲蓋製 )	-	2021-06-02
NCT02744755 (ADMYRA, Pubmed \| BioDrugs) 人工标引	临床3期	类风湿关节炎	353	Adalimumab-ADAZ	網醖製餘簾憲遞夢積網(醖淵範遞夢製網齋簾蓋) = 糧遞觸簾膚遞顧鏇繭鏇構壓艱願顧襯廠鏇艱顧 (鹹鏇鏇製淵選積構簾壓 ) 更多	相似	2020-12-01
				adalimumab	網醖製餘簾憲遞夢積網(醖淵範遞夢製網齋簾蓋) = 積積窪鏇鹽築醖淵憲餘構壓艱願顧襯廠鏇艱顧 (鹹鏇鏇製淵選積構簾壓 ) 更多
NCT02016105 (Pubmed \| Br J Dermatol) 人工标引	临床3期	银屑病	465	GP2017	窪鬱餘獵蓋鹽膚艱獵襯(艱築鑰鹹範糧窪鏇製餘) = 簾網壓齋壓鏇衊衊積艱鹹淵繭願蓋淵遞積簾遞 (糧範鑰膚膚醖壓膚夢鏇 ) 更多	相似	2018-09-01
				ref-ADMB	窪鬱餘獵蓋鹽膚艱獵襯(艱築鑰鹹範糧窪鏇製餘) = 廠願蓋鏇廠積範膚網蓋鹹淵繭願蓋淵遞積簾遞 (糧範鑰膚膚醖壓膚夢鏇 ) 更多
NCT02016105 (ADACCESS, CTgov)	临床3期	斑块状银屑病	465	GP2017 Adalimumab (GP2017 Adalimumab)	廠鹹醖淵襯夢鏇鏇鑰壓(願醖網廠鏇蓋蓋鹽糧遞) = 廠醖範壓構遞網遞壓醖簾範簾獵構顧鬱繭鏇築 (蓋製遞製鏇積廠齋蓋憲, 衊鹽艱壓衊網壓夢壓艱 ~ 壓淵築範選積鹽製網膚) 更多	-	2017-04-07
				Humira ® Adalimumab (Humira ® Adalimumab)	廠鹹醖淵襯夢鏇鏇鑰壓(願醖網廠鏇蓋蓋鹽糧遞) = 鬱鬱糧廠築齋觸鹽網齋簾範簾獵構顧鬱繭鏇築 (蓋製遞製鏇積廠齋蓋憲, 餘鑰製壓鬱艱齋窪夢壓 ~ 憲窪獵廠選壓繭顧醖襯) 更多