阿达木单抗生物类似药 (Samsung Bioepis)(Adalimumab-BWWD (Samsung Bioepis)) - 药物靶点：TNF-α_在研适应症：多关节型幼年特发性关节炎，肠炎，脊柱干骺端发育不良，轴向_专利_临床

概要

基本信息

药物类型

生物类似药、单克隆抗体

别名

Adalimumab biosimilar (Samsung Bioepis)、adalimumab-bwwd

+ [3]

靶点

TNF-α

作用机制

TNF-α抑制剂(肿瘤坏死因子α抑制剂)

治疗领域

免疫系统疾病感染遗传病与畸形+ [4]

在研适应症

多关节型幼年特发性关节炎肠炎脊柱干骺端发育不良，轴向+ [17]

非在研适应症-

原研机构

Samsung Bioepis Co., Ltd.

在研机构

Samsung Bioepis Co., Ltd.Samsung Bioepis AU Pty Ltd

非在研机构-

最高研发阶段批准上市

首次获批日期

欧盟 (2017-08-24),

强直性脊柱炎银屑病关节炎中轴性脊柱关节炎+ [14]

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 26792L

当前序列信息引自: *****

Sequence Code 88699H

当前序列信息引自: *****

关联

8

项与阿达木单抗生物类似药 (Samsung Bioepis) 相关的临床试验

NCT05510063 / Completed临床4期

A Phase IV, Randomized, Double-blind, Parallel-group, Multiple-dose, Active Comparator, Multicenter Clinical Study to Evaluate the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis

This is a Phase IV, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study to evaluate the pharmacokinetics, efficacy, safety, and immunogenicity of SB5 versus Humira in subjects with moderate to severe chronic plaque psoriasis.

开始日期2022-08-04

申办/合作机构

Samsung Bioepis Co., Ltd.

[+1]

EUCTR2022-000695-19-LT / Unknown status临床4期

A Phase IV, Randomised, Double-blind, Parallel-group, Multiple-dose, Active Comparator, Multicentre Clinical Study to Evaluate the Pharmacokonetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira® in Subjects with Moderate to Severe Chronic Plaque Psoriasis

开始日期2022-07-22

申办/合作机构

Samsung Bioepis Co., Ltd.

NCT04514796 / Completed临床1期

A Randomised, Single-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects

This study is to evaluate to compare the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of SB5 in healthy male subjects.

开始日期2020-08-13

申办/合作机构

Samsung Bioepis Co., Ltd.

100 项与阿达木单抗生物类似药 (Samsung Bioepis) 相关的临床结果

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100 项与阿达木单抗生物类似药 (Samsung Bioepis) 相关的转化医学

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100 项与阿达木单抗生物类似药 (Samsung Bioepis) 相关的专利（医药）

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97

项与阿达木单抗生物类似药 (Samsung Bioepis) 相关的文献（医药）

2024-10-01·International Journal of Clinical Pharmacy

A randomised, crossover trial exploring the patient perspective and effectiveness of biosimilar adalimumab transition: IBD reference and biosimilar adalimumab cross over study (iBaSS)

Article

作者: Gonçalves, João ; Latter, Sue ; Harris, Clare ; Addison, Janet ; Young, David ; Harvey, Justin ; Rahmany, Sohail ; Cummings, Fraser ; Iria, Inês

BACKGROUNDPatient satisfaction has been positively associated with adherence which is expected to impact outcomes. Although vital for successful implementation of biosimilar medicines, little is known about the patient perspective of transition.AIMThe aim of this study was to investigate clinical outcomes and patient experience of transitioning between reference adalimumab and a biosimilar (SB5).METHODiBaSS is a phase IV single-centre, prospective, randomised, single-blind, cross-over study in adult subjects with Crohn's disease. Participants, stable on adalimumab before consent, received 24 weeks of treatment with both reference adalimumab and SB5. The primary outcome was the proportion of patients maintaining baseline clinical status throughout each treatment period, with patients' perspective of disease control and treatment satisfaction assessed as secondary outcomes.RESULTSA total of 112 participants, representative of the heterogeneous patient populations encountered in routine clinical practice, were enrolled. A similar proportion of participants maintained baseline clinical status through each treatment period: 81.8% with reference adalimumab and 79.5% with SB5. Patient reported outcomes (IBD-Control questionnaire (SB5: 15.5; reference adalimumab 15) and TSQM), adverse events and therapeutic drug monitoring remained consistent through both treatment periods, although a higher median injection pain VAS score was noted with SB5 (53/100 versus 6/100 with reference adalimumab). The number of switches undertaken in the study did not impact serum drug concentration or immunogenicity.CONCLUSIONThis study, mimicking real world adalimumab transition, demonstrates that patients undertaking brand transition can be expected to have consistent clinical and satisfaction outcomes.CLINICAL TRIAL REGISTERED WITH EUDRACTNumber 2018-004967-30.

2024-09-13·Ocular Immunology and Inflammation

Efficacy and Safety of Switching from Adalimumab Originator to SB5, Adalimumab Biosimilar for Noninfectious Uveitis

Article

作者: Woo, Se Joon ; Song, Seok Hyeon

PURPOSETo evaluate the efficacy and safety of switching from adalimumab originator (Humira, AbbVie) to SB5, adalimumab biosimilar (Adalloce, Samsung Bioepis) in patients with noninfectious uveitis (NIU).METHODSFifteen patients (29 eyes) with NIU who were switched from adalimumab originator to SB5 and followed up for 6 months or longer were retrospectively included. Data consisted of best-corrected visual acuity (BCVA, logMAR), intraocular pressure (IOP, mmHg), anterior chamber (AC) cell grade, anterior vitreous (AV) cell grade, vitreous haze grade, central macular thickness (CMT, μm), and macular volume (MV, mm³) at pre-switching, 2, 4, and 6 months post-switching.RESULTSThere were no significant differences in BCVA, AC and AV cell grades, and vitreous haze grades at 2, 4, and 6 months post- compared with pre-switching, and no significant differences in CMT and MV at 2 and 6 months post-switching. CMT and MV decreased from 260.55 ± 67.44 μm and 8.37 ± 1.14 mm³ at pre-switching to 244.14 ± 60.31 μm (p = 0.032) and 8.11 ± 1.20 mm³ (p = 0.027) at 4 months post-switching, respectively. There was no recurrence of uveitis, as defined by AC cell grade, vitreous haze, or BCVA. Four patients (27%) were switched back to adalimumab originator after a mean of 9 weeks, due to discomfort during the injection (three patients) and technical difficulty with the new injection device (one patient). No other adverse events occurred after switching to SB5.CONCLUSIONSwitching from adalimumab originator to SB5 for NIU does not result in clinically significant differences in treatment efficacy and safety.

2024-03-01·Journal for ImmunoTherapy of Cancer

Cancer-oocyte SAS1B protein is expressed at the cell surface of multiple solid tumors and targeted with antibody-drug conjugates

Article

作者: Mandal, Arabinda ; Adair, Sara J ; Bauer, Todd W ; Pires, Eusebio S ; Shetty, Jagathpala ; Tran, Christine A ; Slingluff, Craig L ; Ban, Bhupal ; Mandal, Mriganka ; Olson, Walter C ; Herr, John C

BackgroundSpermacrosomalSLLP1 binding (SAS1B) protein is found in oocytes, which is necessary for sperm-oocyte interaction, and also in uterine and pancreatic cancers. Anti-SAS1B antibody-drug conjugates (ADCs) arrested growth in these cancers. However, SAS1B expression in cancers and normal tissues has not been characterized. We hypothesized that SAS1B is expressed on the surface of other common solid cancer cells, but not on normal tissue cells, and might be selectively targeted therapeutically.MethodsSAS1B expression in human normal and cancer tissues was determined by immunohistochemistry, and complementary DNA (cDNA) libraries were employed to PCR amplify human SAS1B and its transcripts. Monoclonal antibodies (mAbs) to human SAS1B were generated using mouse hybridomas. SAS1B deletion constructs were developed to map SAS1B’s epitope, enabling the creation of a blocking peptide. Indirect immunofluorescence (IIF) of human transfected normal and cancer cells was performed to assess SAS1B expression. SAS1B intracellular versus surface expression in normal and tumor tissues was evaluated by flow cytometry after staining with anti-SAS1B mAb, with specificity confirmed with the blocking peptide. Human cancer lines were treated with increasing mAb and ADC concentrations. ATP was quantitated as a measure of cell viability.ResultsSAS1B expression was identified in a subset of human cancers and the cytoplasm of pancreatic islet cells. Two new SAS1B splice variants were deduced. Monoclonal antibodies were generated to SAS1B splice variant A. The epitope for mAbs SB2 and SB5 is between SAS1B amino acids 32–39. IIF demonstrated intracellular SAS1B expression in transfected kidney cells and on the cell surface of squamous cell lung carcinoma. Flow cytometry demonstrated intracellular SAS1B expression in all tumors and some normal cells. However, surface expression of SAS1B was identified only on cancer cells. SB2 ADC mediated dose-dependent cytotoxic killing of multiple human cancer lines.ConclusionSAS1B is a novel cancer-oocyte antigen with cell surface expression restricted to cancer cells. In vitro, it is an effective target for antibody-mediated cancer cell lysis. These findings support further exploration of SAS1B as a potential therapeutic cancer target in multiple human cancers, either with ADC or as a chimeric antigen receptor-T (CAR-T) cell target.

49

项与阿达木单抗生物类似药 (Samsung Bioepis) 相关的新闻（医药）

2024-11-18

·PipelineReview

Samsung Bioepis and Biogen Receive European Commission (EC) Approval for Aflibercept Biosimilar, OPUVIZ

INCHEON, South Korea and CAMBRIDGE, MA, USA I November 18, 2024 I Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European Commission (EC) has approved OPUVIZ™ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea 1,2 (aflibercept), developed and registered by Samsung Bioepis. OPUVIZ, also known as SB15, is approved in adult patients for the treatment of neovascular (wet) age related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV). “Retinal disorders are affecting millions of people’s lives in Europe, yet many patients face barriers to treatment due to high costs,” said Byoungin Jung, Vice President, Regulatory Affairs at Samsung Bioepis. “The EC approval for OPUVIZ represents a major step toward our goal of expanding access to vital biologic therapies for those in need. We will continue working to expand access to our quality-assured, safe and effective biosimilars to improve patient’s quality of life and support sustainability of healthcare systems.” “This approval is an exciting milestone for both patients and healthcare systems in Europe. OPUVIZ has the potential to create a new treatment option for eligible patients, while also easing the burden of costs associated with these retinal conditions,” said Wolfram Schmidt, Head of Europe at Biogen. “We are delighted to continue our partnership with Samsung Bioepis, with the approval of our fifth biosimilar treatment option in Europe.” The EC approval was based on a totality of evidence including analytical, non-clinical data, and clinical data. A randomized, double-masked, parallel group, multicenter Phase 3 study demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PK) profiles between SB15 and reference aflibercept (AFL). The primary endpoint was met in terms of change from baseline in best corrected visual acuity (BCVA) at week 8, and the 32-week interim analysis and 56-week analysis demonstrated comparability in other secondary efficacy, safety, immunogenicity, and PK endpoints between SB15 and AFL. 3, 4 OPUVIZ is the second ophthalmology biosimilar approved in Europe and fifth biosimilar in the portfolio developed by Samsung Bioepis with commercialization rights held by Biogen, which includes BYOOVIZ™ (ranibizumab), BENEPALI™ (etanercept), IMRALDI™ (adalimumab) and FLIXABI™ (infliximab). In November 2019, Samsung Bioepis and Biogen announced that they had entered into a commercialization agreement for two ophthalmology biosimilar candidates, BYOOVIZ (SB11, ranibizumab) and OPUVIZ (SB15, aflibercept), in the U.S., Canada, Europe and certain other markets. About the SB15 Phase 3 study 3,4 The study is a randomized, double-masked, parallel group phase 3 study conducted at 56 centers in 10 countries from June 2020 to March 2022, including follow-up through 56 weeks. Of 549 screened participants, 449 participants 50 years and older with treatment-naive nAMD were randomized 1:1 to receive either SB15 (n = 224) or AFL (n = 225). At Week 32, patients were re-randomized to either continue SB15 or AFL, or switch from AFL to SB15 resulting in three treatment groups; continuing SB15 (SB15/SB15, n=219), continuing AFL (AFL/AFL, n=108), switching from AFL to SB15 (AFL/SB15, n=111). In total, 425 patients completed up to Week 56. Key efficacy endpoints of the study were 1) change from baseline in best corrected visual acuity (BCVA), 2) change from baseline in central subfield thickness (CST), and 3) proportion of patients with intra or sub-retinal fluid. About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X , LinkedIn . About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at www.biogen.com . Follow us on social media – Facebook , LinkedIn , X , YouTube . References: SOURCE: Samsung Bioepis

临床3期临床结果上市批准引进/卖出

2024-10-07

·PRNewswire

Prime Therapeutics announces new, cost-effective Humira® biosimilar solutions, offering clients flexibility and choice

EAGAN, Minn., Oct. 7, 2024 /PRNewswire/ -- Prime Therapeutics LLC (Prime) today announced new, cost-effective Humira biosimilar solutions, offering clients continued flexibility and choice, along with financial risk mitigation strategies designed to maintain and promote access to biosimilars for millions of Americans. These new solutions reflect Prime's distinctive conflict-free approach to the prescription drug supply chain model by offering clients access to biosimilar therapies through a broad network of quality specialty pharmacies. Beginning in 2025, Prime will recommend four manufacturers that offer new biosimilar options for plans, including Organon (Hadlima®), Teva (Simlandi®), Sandoz (adalimumab-adaz), and Celltrion (adalimumab-aaty). Plan options will include retaining Humira® in a parity position to biosimilars, biosimilars first, or biosimilars only strategies. All solutions offer clients access to four, low list-price biosimilar options, with net costs as low as $500-600 per 30-day supply. Adding these solutions deliver more options to the market that allow providers, pharmacies and members choice, leading to biosimilar conversion success. Further, Prime's recommended options have robust biosimilar pipelines, demonstrating a long-term investment in success in the market to provide members with stability and access to their necessary therapies. Prime also supports the efforts of biosimilar manufacturers to provide patient support to keep out-of-pocket costs affordable for most commercial members. "As a trusted, truly transparent pharmacy partner, Prime curates the best solutions, customized for our clients' needs," said Dave Schlett, executive vice president and president, PBM solutions at Prime. "When assessing which option to pursue, clients need to consider the existing member impact, as well as the ability to shift drug market shares to ensure that total plan cost objectives and member savings are achieved." Prime is committed to generating savings, simplifying the navigation of the pharmacy benefit and supporting members on their care management journey. About Prime Therapeutics Prime Therapeutics LLC (Prime) is a diversified pharmacy solutions organization. We offer innovative pharmacy benefit management, specialty and medical drug management, and state government solutions to millions of people across the country. At Prime, we're reimagining pharmacy solutions to provide the care we'd want for our loved ones. We challenge the way it's always been done to develop intelligently designed solutions that deliver savings, simplicity and support to help people achieve better health. For more information, visit us at PrimeTherapeutics.com or follow us on LinkedIn. SOURCE Prime Therapeutics LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

生物类似药

2024-09-24

·FiercePharma

Docs discuss sluggish switch to Humira biosimilars, name preferred off-patent options

Spherix Global Insights looked at which biosimilar brands stand to benefit as AbbVie loses access. Spherix Global Insights has provided a different angle on AbbVie’s successful retention of Humira sales in the face of biosimilar competition, polling doctors about forces shaping the market and their preferred off-patent options.AbbVie reported global Humira sales of $2.8 billion in the second quarter. That represented a 29% drop on an operational basis but meant Humira remained a major product more than one year on from the launch of the first biosimilar in the U.S. Spherix surveyed 313 physicians, split roughly evenly between gastroenterologists, rheumatologists and dermatologists, to understand what is happening.Significantly more gastroenterologists than rheumatologists or dermatologists expressed favorable views of biosimilars, Spherix said. Nearly half of gastroenterologists proactively choose to prescribe biosimilar brands, the survey found, but rheumatologists and dermatologists have largely been driven to off-patent options by “external pressures.” Those pressures have intensified slower than some people expected.One rheumatologist said two years ago they would have predicted Humira would only account for 10% of the market by late 2024. Yet, at the time of the survey in April, the rheumatologist wasn’t seeing that split nor encountering any issues when prescribing Humira. Another physician said they felt about 30% of patients were on biosimilars, with the rest staying on Humira. The second physician also expected biosimilars to penetrate the market faster and to face “this whole tsunami of just lots and lots of work and just the sudden shift.” Yet, so far, the shift has “been odd,” the physician said in April, because “it's not every payer and it hasn't been as awful as I thought it would be.”AbbVie expects to “maintain parity access to biosimilars for a significant majority of patient lives this year,” Jeffrey Stewart, the company’s chief commercial officer, said on an earnings call in July. Asked by an analyst about 2025, Stewart said Humira access “will certainly be lower than this year,” but AbbVie expects to maintain parity access for a “meaningful” portion of patients across all channels.Spherix looked at which biosimilar brands stand to benefit as AbbVie loses access. Gastroenterologists still favor Amgen’s Amjevita, the first Humira biosimilar to launch in the U.S., but are gradually increasing their use of unbranded adalimumab, as sold by Sandoz, Boehringer Ingelheim and Biocon, and Samsung Bioepis and Organon’s Hadlima. Physicians in the other specialties are increasingly using Hadlima, too.Specific biosimilar brand usage depends on what is covered by the patient’s insurance. As well as fighting among themselves, biosimilar manufacturers face competition from AbbVie’s Humira successors Skyrizi and Rinvoq. Stewart said AbbVie saw around 20% of patients move to drugs with other mechanisms, such as Skyrizi and Rinvoq, when they lost access to Humira.

生物类似药专利到期上市批准

100 项与阿达木单抗生物类似药 (Samsung Bioepis) 相关的药物交易

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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
强直性脊柱炎	冰岛	Samsung Bioepis Co., Ltd.	2017-08-24
强直性脊柱炎	挪威	Samsung Bioepis Co., Ltd.	2017-08-24
强直性脊柱炎	列支敦士登	Samsung Bioepis Co., Ltd.	2017-08-24
强直性脊柱炎	欧盟	Samsung Bioepis Co., Ltd.	2017-08-24
非感染性前葡萄膜炎	列支敦士登	Samsung Bioepis Co., Ltd.	2017-08-24
非感染性前葡萄膜炎	挪威	Samsung Bioepis Co., Ltd.	2017-08-24
非感染性前葡萄膜炎	冰岛	Samsung Bioepis Co., Ltd.	2017-08-24
非感染性前葡萄膜炎	欧盟	Samsung Bioepis Co., Ltd.	2017-08-24
斑块状银屑病	挪威	Samsung Bioepis Co., Ltd.	2017-08-24
斑块状银屑病	冰岛	Samsung Bioepis Co., Ltd.	2017-08-24
斑块状银屑病	欧盟	Samsung Bioepis Co., Ltd.	2017-08-24
斑块状银屑病	列支敦士登	Samsung Bioepis Co., Ltd.	2017-08-24
银屑病	欧盟	Samsung Bioepis Co., Ltd.	2017-08-24
银屑病	列支敦士登	Samsung Bioepis Co., Ltd.	2017-08-24
银屑病	冰岛	Samsung Bioepis Co., Ltd.	2017-08-24
银屑病	挪威	Samsung Bioepis Co., Ltd.	2017-08-24
葡萄膜炎	挪威	Samsung Bioepis Co., Ltd.	2017-08-24
葡萄膜炎	列支敦士登	Samsung Bioepis Co., Ltd.	2017-08-24
葡萄膜炎	欧盟	Samsung Bioepis Co., Ltd.	2017-08-24
葡萄膜炎	冰岛	Samsung Bioepis Co., Ltd.	2017-08-24

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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


BADBIR (EADV2022)	N/A	银屑病	-	SB5	鏇顧遞壓齋顧鹹構膚襯(鹹膚鬱鹹壓遞糧顧齋製) = Common reasons for SB5 discontinuation were inefficacy (10.6%) and adverse events (9.9%) 鑰選鏇遞鏇淵鏇壓選製 (築顧繭鹽廠鹹醖遞廠廠 ) 更多	积极	2022-09-07
PROPER (EULAR2022)	N/A	银屑病关节炎 \| 类风湿关节炎 \| 中轴性脊柱关节炎	1,000	SB5	淵衊鬱窪襯築鹽蓋鹽鑰(艱襯繭構衊繭淵憲夢窪) = 顧窪遞遞憲膚製窪網築淵窪製簾餘鑰蓋簾廠網 (鬱繭壓簾網窪衊積憲艱, 11.4) 更多	-	2022-06-01
NCT02326233 (CTgov)	临床1期	-	190	Pen of SB5 (Pen of SB5)	鏇襯壓範餘淵構餘願願(製獵蓋淵願膚齋鏇鬱獵) = 憲鬱獵廠繭憲鏇鏇願齋膚淵憲遞網淵醖夢餘願 (齋構膚積齋積觸鹹鹹網, 壓蓋鹽齋築鹽範襯積簾 ~ 鏇獵網蓋築醖鹹網襯鬱) 更多	-	2019-03-18
				PFS of SB5 (PFS of SB5)	鏇襯壓範餘淵構餘願願(製獵蓋淵願膚齋鏇鬱獵) = 憲餘觸鹹夢構醖淵簾艱膚淵憲遞網淵醖夢餘願 (齋構膚積齋積觸鹹鹹網, 齋醖壓糧願選醖壓遞繭 ~ 蓋衊鬱範遞簾憲衊願鏇) 更多
NCT02326233 (Pubmed \| Drug Des Devel Ther) 人工标引	临床1期	-	95	SB5 (delivered subcutaneously via AI)	(觸網積顧壓獵蓋壓觸獵) = For the primary endpoints, the 90% CIs for the ratio of geometric least squares means for SB5 AI to SB5 PFS ranged between 0.9503 and 1.2240, which were all within the equivalence margin of 0.80-1.25 窪鏇網製簾鑰餘衊構製 (製觸網鑰範鏇構簾築鬱 )	不佳	2018-11-05
				SB5 (delivered subcutaneously PFS)
NCT02144714 (CTgov)	临床1期	-	189	US sourced Humira®+SB5 (EU Sourced Humira®)	觸鬱鑰獵簾顧鏇蓋夢艱(醖醖積餘廠艱衊鏇鏇鹽) = 餘醖齋繭淵餘膚繭蓋醖廠夢顧鹹膚鹽餘糧獵齋 (壓繭選壓醖遞襯衊遞衊, 製製糧構獵鑰醖衊壓衊 ~ 蓋膚鹽鹹鬱鏇製網鬱鬱) 更多	-	2018-09-21
				EU sourced Humira® (US Sourced Humira®)	觸鬱鑰獵簾顧鏇蓋夢艱(醖醖積餘廠艱衊鏇鏇鹽) = 構壓網選夢網築衊膚醖廠夢顧鹹膚鹽餘糧獵齋 (壓繭選壓醖遞襯衊遞衊, 窪襯鹽願願齋淵齋築齋 ~ 鬱顧鬱選願築鏇積製憲) 更多
NCT02167139 (Pubmed)	临床3期	类风湿关节炎	544	SB5	(餘夢觸觸構願願夢繭獵) = 餘鹹繭夢鏇製網衊繭鹽鹽膚衊醖廠鹹餘齋鑰構 (艱壓膚夢網糧蓋製構艱 )	积极	2018-01-01
				Reference ADA	(餘夢觸觸構願願夢繭獵) = 齋襯糧範襯鹹鏇鹹觸醖鹽膚衊醖廠鹹餘齋鑰構 (艱壓膚夢網糧蓋製構艱 )
EULAR2017	临床3期	-	-	SB5 (Adalimumab Biosimilar)	(積獵鑰壓積選積醖願衊) = 遞繭廠襯觸夢簾餘獵觸築選構壓築艱淵憲築遞 (顧醖製鹽鏇獵艱膚襯襯 )	-	2017-06-14
				Reference Adalimumab (ADL)	(積獵鑰壓積選積醖願衊) = 淵鹽鑰鑰鏇餘構夢積鹽築選構壓築艱淵憲築遞 (顧醖製鹽鏇獵艱膚襯襯 )
NCT02167139 (CTgov)	临床3期	类风湿关节炎	544	SB5 (proposed biosimilar to adalimumab) (SB5 (Proposed Biosimilar to Adalimumab))	糧鏇鹹鏇窪顧鹹齋壓窪(顧遞淵夢網壓築獵蓋願) = 繭壓艱醖壓憲廠願艱顧獵構衊遞觸製顧艱鹽積 (簾襯鹹範壓築襯獵鬱繭, 構鹽膚齋餘鑰範製襯醖 ~ 鑰製構遞簾廠糧夢鹽鏇) 更多	-	2017-01-19
				Humira (adalimumab)+SB5 (proposed biosimilar to adalimumab) (Humira (Adalimumab))	糧鏇鹹鏇窪顧鹹齋壓窪(顧遞淵夢網壓築獵蓋願) = 繭製襯製齋鏇糧繭襯衊獵構衊遞觸製顧艱鹽積 (簾襯鹹範壓築襯獵鬱繭, 觸鬱憲鹹鑰構膚鏇範窪 ~ 窪顧夢艱願積廠鏇膚窪) 更多
PHASE I PHARMACOKINETIC STUDY (EULAR2015)	临床1期	-	189	SB5	(衊鹽膚壓獵範遞淵蓋構) = 衊觸窪淵膚構遞構憲築鹹網窪醖鹽壓壓繭製願 (鹹構蓋壓願鏇蓋積壓糧, 0.885 ~ 1.108) 更多	积极	2015-06-10
				EU-ADL	(衊鹽膚壓獵範遞淵蓋構) = 構選鏇齋餘鬱壓壓齋襯鹹網窪醖鹽壓壓繭製願 (鹹構蓋壓願鏇蓋積壓糧, 0.904 ~ 1.131) 更多