This study will evaluate the retention rates of two advanced therapies, Tumour Necrosis Factor (TNF) and Janus kinase inhibitor (JAK) in the treatment of adults with Rheumatoid Arthritis (RA) over a two year period. It will also examine the ability to embed a clinical trial in a clinical situation using an electronic medical record (EMR).

Start Date01 Mar 2020

Sponsor / Collaborator

Lawson Health Research Institute

NCT03813771 / Unknown statusPhase 4IIT

Targeted Treatment Early With Etanercept Plus Methotrexate Versus T2T Care for DMARD-naïve Early RA Patients. A Prospective, Longitudinal Cohort Study With Embedded Pilot Randomised Controlled Trial to Assess Treatment Rationalisation Based on naïve T-cell Stratification.

The main aim of the study is to determine the clinical utility of naive T-cell stratification for rationalising treatment with methotrexate (MTX), for DMARD-naive early RA patients. Thus, it aims to determine whether TNFi therapy (Benepali) instituted as first-line therapy in DMARD-naive early RA patients with poor T-cell prognostication confers better outcomes (clinical, structural and immunological). Hence, this would enable early targeted treatment for those with a poorer prognosis based on their immunological status.

Start Date01 Mar 2019

Sponsor / Collaborator

University of Leeds

[+1]

NCT03729674 / Unknown statusNot Applicable

Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs

In Canada and worldwide there is a need for updated independent real-world comparative effectiveness and safety data related to biologic drugs including biosimilar drugs. Biosimilar drugs hold potential to improve access to needed therapies at reduced cost enabling savings to be reallocated to other needs. However updated real-world evidence on comparative effectiveness and safety of biosimilar drugs is lacking. Investigators aim to demonstrate feasibility of creating network of clinical cohorts and other resources to provide real-world information on use of biosimilar drugs in Canada.
The core revolves around clinical datasets but investigators will complement with other data sources. Investigators will review data from National Prescription Drug Utilization Information System database that contains prescription claims-level data collected from publicly financed drug benefit programs in different provinces to conduct an environmental scan of the use of biosimilars and respective legacy drugs and other anti-Tumor Necrosis Factor agents covered by provincial drug plans from 2014-2017. Initial analysis will help to confirm that use of biosimilars is lower than corresponding legacy drugs.
Biologic drugs are relatively new and expensive drugs; biosimilar medicines are similar to original biologic drugs but cost less. If patients receive biosimilar drugs rather than originator biologics healthcare systems may be able to save money. Those savings can be used for other health care needs to benefit more Canadians. However investigators do not have detailed information on safety and effectiveness of these biosimilar drugs. The aim of study is to compare safety and effectiveness of biosimilar drugs to originator biologic drugs. Investigators will study patients with inflammatory rheumatic diseases (RA and AS) and Inflammatory Bowel Disease (CD and UC) and across Canada on these drugs. Primary focus is on patients without history of biologic drug use but investigators will also study patients switching to biosimilar drug from an originator biologic drug. Investigators will measure how long patients stay on treatment, if patients require new treatment, if the patients' disease control improves and occurrence of side effects such as infection that could be related to these drugs.

Start Date26 Nov 2018

Sponsor / Collaborator

McGill University Health Center

[+8]

100 Clinical Results associated with Etanercept-YKRO(Samsung Bioepis Co., Ltd.)

100 Translational Medicine associated with Etanercept-YKRO(Samsung Bioepis Co., Ltd.)

100 Patents (Medical) associated with Etanercept-YKRO(Samsung Bioepis Co., Ltd.)

Literatures (Medical) associated with Etanercept-YKRO(Samsung Bioepis Co., Ltd.)

01 Sep 2023·Arthritis care & research

Effectiveness and Persistence in SB4‐ and Reference Etanercept–Treated Rheumatoid Arthritis Patients in Ordinary Clinical Practice in Norway

Article

Author: Diamantopoulos, Andreas ; Pripp, Are Hugo ; Haugeberg, Glenn ; Rødevand, Erik ; Hansen, Inger Johanne Widding ; Bakland, Gunnstein

Objective:

Biosimilars represent cost‐effective alternatives to reference biologic disease‐modifying antirheumatic drugs. Our objective was to compare drug effectiveness and drug persistence in the treatment of rheumatoid arthritis (RA), assessing the etanercept biosimilar SB4 in efficacy and safety compared with reference etanercept in a Phase III, randomized controlled trial. We applied EULAR Points to Consider for Comparative Effectiveness Research in a retrospective database study of etanercept and SB4 in patients treated in clinical practice in Norway.

Methods:

Patients with RA (n = 1,455) treated with etanercept or SB4 between 2010 and 2018 at 5 centers in Norway with ≥1 year of follow‐up were included. Disease outcomes (Disease Activity Score in 28 joints [DAS28] at week 52) and drug persistence were compared between unmatched etanercept (n = 575) and SB4 (n = 299) cohorts and matched analyses (n = 172, both cohorts) using propensity score (PS) matching to adjust for confounders.

Results:

In unmatched analyses, the difference in change from baseline between etanercept (n = 221) and SB4 (n = 106) for DAS28 at week 52 was mean –0.02 (95% confidence interval [95% CI] –0.32, 0.27), demonstrating equivalence by the predetermined equivalence margin (±0.6). In PS‐matched analyses, the difference between etanercept (n = 49) and SB4 (n = 49) was 0.03 (95% CI –0.46, 0.52), within the predefined equivalence margin. Persistence using the drug at week 52 was similar between etanercept (0.62 [95% CI 0.57, 0.65]) and SB4 (0.66 [95% CI 0.60, 0.71]) cohorts in the unmatched analysis; in PS‐matched cohorts, persistence at week 52 was 0.52 (95% CI 0.44, 0.59) for etanercept and 0.68 (95% CI 0.61, 0.75) for SB4.

Conclusion:

Outcomes for disease status/drug persistence at week 52 were similar between patients with RA treated with etanercept or SB4.

01 Aug 2023·Clinical drug investigation

Healthcare Professional (HCP) and Patient Usability Evaluation and Preferences of Two Auto-injector Devices for Self-Injection of Biosimilars, SB4 and SB5: A Literature Review.

Review

Author: Bouhnik, Yoram ; Cummings, J R Fraser ; Armuzzi, Alessandro ; Young, David ; Kim, Jihyun ; Thaci, Diamant ; Corominas, Héctor

BACKGROUND:

Numerous biologic drugs, including etanercept and adalimumab, are administered subcutaneously. This study reviewed the evidence on the usability and preference of self-injection devices of SB4 and SB5 compared with the reference product injectors.

METHODS:

A systematic search was conducted in PubMed using the search string "(Imraldi OR Hadlima OR SB5 OR Benepali OR Brenzys OR SB4) AND (preference) AND (device)" covering the period from 28 January 2016 (first introduction of SB4) to 31 May 2022. Only articles and abstracts on usability or preference-rating of SB4 and SB5 autoinjectors (AI) written in English were selected. Additional papers identified via manual search supplemented the retrieved papers.

RESULTS:

A total of nine articles and one conference poster were selected (seven surveys, one observational study, and two phase II studies). Overall, participants of the studies included nurses and rheumatologists, as well as patients who were from three medical specialties where these medicines are most commonly used (rheumatology, gastroenterology, and dermatology). The majority of patients and healthcare professionals rated ease of use and ease of grip as the most important device attributes. SB4/Pen and SB5/Pen were mostly preferred over their prefilled syringes (PFS), Enbrel/Pen, and Humira/Pen.

CONCLUSION:

The analyzed data on usability and device preference indicate that SB4/Pen and SB5/Pen were preferred over the other reference product autoinjectors, thanks to their button-free design, auditory and visual injection feedback, and overall ease of use. Therefore, they were preferred over the other reference product autoinjectors. Because user-friendly devices can improve treatment adherence, pharmaceutical companies should consider patient convenience when developing medical devices.

01 Apr 2023·Rheumatology and therapy

Safety and Effectiveness of Etanercept Biosimilar SB4 for Rheumatic Diseases in South Korea: Real-World Post-marketing Surveillance Data

Article

Author: Yoo, Wan-Hee ; Lee, Jiwon ; Lee, Yeon-Ah ; Kim, Dong Wook ; Sung, Yoon-Kyoung ; Choe, Jung-Yoon ; Lee, Sang-Hoon ; Gu, Dong-Ha ; Kang, Eun Ha ; Kang, Young Mo ; Suh, Chang-Hee

INTRODUCTION:

SB4 is the first approved biosimilar of etanercept, a biologic tumor necrosis factor inhibitor, to treat various autoimmune diseases including axial spondylarthritis (axSpA), rheumatoid arthritis (RA), psoriatic arthritis (PsA), and plaque psoriasis (PsO). This post-marketing surveillance (PMS) study of SB4 investigated safety and effectiveness in routine clinical practice and is part of the drug approval process in Korea.

METHODS:

This prospective, multi-center, open-label, observational, phase IV PMS study was designed to enroll patients with axSpA, RA, PsA, and PsO in Korea from September 2015 to September 2019. Both etanercept-naïve patients or patients switched from reference etanercept were included. SB4 was administered weekly via subcutaneous injections using pre-filled syringes. Safety was assessed by the incidence of adverse events (AEs), adverse drug reactions (ADRs) and serious adverse events (SAE). Effectiveness was assessed by the change from baseline of investigator-rated Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in patients with ankylosing spondylitis (AS) and disease activity score-28 (DAS28) in patients with RA.

RESULTS:

Among 316 enrolled patients, 314 were included in the safety analysis (176 with AS and 138 with RA). The overall incidence of AEs, ADRs and serious AEs were 17.8, 9.9, and 1.3%, respectively. Most AEs were mild (66.7%) or moderate (31.1%) and not related to SB4 (58.9%). Most common AEs were injection site pruritus (1.9%) and injection site rash (1.3%). At week 24, mean disease activity scores significantly decreased compared to baseline in naïve patients with AS and RA (BASDAI 2.7 vs. 6.2, p < 0.0001; DAS28 3.8 vs. 5.7, p < 0.0001) and in switched patients with AS and RA (BASDAI 1.0 vs. 1.3, p = 0.0018; DAS28 2.4 vs. 2.9, p = 0.0893).

CONCLUSION:

This first real-world evidence of SB4 from a phase IV PMS study in Korea shows comparable effectiveness to historical SB4 real-world evidence without any new significant safety signals.

News (Medical) associated with Etanercept-YKRO(Samsung Bioepis Co., Ltd.)

26 Apr 2024

·www.globenewswire.com

Biogen Receives Positive CHMP Opinion for TOFIDENCE™ (tocilizumab), a Biosimilar Referencing ROACTEMRA®

CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE™ to the reference product ROACTEMRA® April 25, 2024 -- Biogen Inc. (Nasdaq: BIIB) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for TOFIDENCE™ (tocilizumab), a biosimilar monoclonal antibody referencing ROACTEMRA®1. The intravenous formulation of TOFIDENCE has been recommended for approval for the treatment of moderate to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19. The CHMP’s positive opinion will now be referred to the European Commission (EC), which will decide whether to grant marketing authorization for TOFIDENCE. If a marketing authorization is granted by the EC, TOFIDENCE will be an addition to the existing biosimilars portfolio of three widely prescribed anti-TNF biosimilars commercialized by Biogen in Europe: BENEPALI (etanercept), IMRALDI (adalimumab) and FLIXABI (infliximab), offering an extension to the cost-effective treatment options with an additional mechanism of action. “The positive CHMP recommendation for TOFIDENCE marks another positive step toward helping more people with inflammatory and immune mediated conditions gain access to leading therapies,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “Positive CHMP recommendation for TOFIDENCE is testament to our continuing efforts to develop and deliver high-quality and proven biologic medicines to more patients, healthcare providers and healthcare systems in Europe.” This positive CHMP opinion on TOFIDENCE was based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of TOFIDENCE was conducted and supports equivalence with the reference biologic product. Additionally, a randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of TOFIDENCE with both the EU and US reference tocilizumab in healthy volunteers, while a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study compared TOFIDENCE with tocilizumab to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with rheumatoid arthritis inadequately controlled by methotrexate. The totality of evidence demonstrated TOFIDENCE is a biosimilar of the reference biologic. Biogen and Bio-Thera entered into a commercialization and licensing agreement for TOFIDENCE (BAT1806/BIIB800) in April 2021. Under the agreement, TOFIDENCE, developed by Bio-Thera, is to be commercialized by Biogen in the European Union. Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China (including Hong Kong, Macau and Taiwan). TOFIDENCE (tocilizumab), an inteleukin-6 receptor antagonist, is a treatment developed as a biosimilar to the reference product ROACTEMRA. TOFIDENCE is indicated for the treatment of moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19. 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. References: RoActemra® is a registered trademark of Genentech, Inc. The content above comes from the network. if any infringement, please contact us to modify.

License out/inDrug Approval

11 Oct 2023

·www.globenewswire.com

Samsung Bioepis Presents Two Abstracts at EADV 2023 Congress, Highlighting Continuous Dedication in Dermatology

Phase 3 study for SB17, Samsung Bioepis’ ustekinumab biosimilar candidate, demonstrates biosimilarity with reference ustekinumab through equivalent efficacy and comparable safety and pharmacokinetics (PK) up to Week 28Also presents 4-year follow-up data of efficacy and safety of adalimumab biosimilar SB5 in patients with moderate to severe psoriasis from British Association of Dermatologics and Immunomodulators Register (BADBIR) INCHEON, South Korea, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd.’s new data on its ustekinumab biosimilar candidate SB17 and four-year follow-up data for its adalimumab biosimilar SB5 are presented today at the European Academy of Dermatology and Venereology (EADV) Congress being held from October 11 to 14 in Berlin, Germany. The Phase 3 study for SB17, a proposed biosimilar to Stelara1 (ustekinumab), was a randomized double-blind study to compare efficacy, safety, pharmacokinetics (PK), and immunogenicity of SB17 with reference ustekinumab (UST) in patients with moderate to severe plaque psoriasis. The study demonstrated biosimilarity of SB17 to UST through equivalent efficacy and comparable safety and PK up to Week 28. The study met the primary endpoint - percent change from baseline in Psoriasis Area Severity Index (PASI) at Week 12, with an adjusted difference of -0.6 (95% confidence interval (CI): [−3.780 to 2.579], per-protocol set), being fully contained within the pre-defined equivalence margin. Other efficacy and safety endpoints were comparable up to Week 28. SB17 is Samsung Bioepis’ fourth candidate in immunology pipeline, following SB4 (etanercept), SB2 (infliximab) and SB5 (adalimumab). In September, the company announced a partnership deal with Sandoz to commercialize SB17 in the United States (US), Canada, European Economic Area (EEA), Switzerland and United Kingdom (UK). Samsung Bioepis also shared 4-year follow-up data of effectiveness and safety of its adalimumab biosimilar SB5 in patients with moderate to severe psoriasis from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) - a UK and Ireland registry that assesses the long-term safety of biologic treatments for psoriasis, in which Samsung Bioepis has participated since May 2016. The 4-year follow-up data of eligible patients treated with SB5 between June 2019 and August 2022 from BADBIR indicated that SB5 can be started or transitioned from reference adalimumab in patients with moderate-to-severe psoriasis with an effectiveness and safety profile. “Presenting two abstracts at EADV demonstrates our continuous commitment to providing clinically proven biosimilars in terms of efficacy, safety and immunogenicity to patients who need them and making physicians and patients confident on use of biosimilar in real setting,” said Hyejin Kim, Vice President and Medical and Lifecycle Safety Team Leader at Samsung Bioepis. SB5 was approved by the European Commission (EC) in August 2017, under the brand name IMRALDI™ as a biosimilar to HUMIRA2. In Europe, IMRALDI™ is commercialized by Biogen along with BENEPALI™ (etanercept; SB4) and FLIXABI™ (infliximab; SB2). Samsung Bioepis’ and Biogen’s anti-TNF treatment products have helped nearly 256,0003 patients in Europe. Details of the Samsung Bioepis’ abstracts are as follows: Abstract TitleAbstract DetailsA Randomised, Double-blind, Phase III Study Demonstrating Clinical Similarity of SB17 (Proposed Ustekinumab Biosimilar) to Reference Ustekinumab in Patients with Moderate to Severe Plaque PsoriasisAbstract ID: 1320Poster ID: P0720Poster Open Date/Time: Oct 11, 9:00 AMAuthors: Steven Feldman, Joanna Narbutt, Giampiero Girolomoni, Jan Brzezicki, Nataliya Reznichenko, Maria Agnieszka Zegadlo-Mylik, Grazyna Pulka, Magdalena Dmowska-Stecewicz, Elżbieta Kłujszo, Dmytro Rekalov, Lidia Rajzer, Jiyoon Lee, Minkyung Lee, and Young Hee RhoLong-Term Real-World Data of SB5 (Adalimumab Biosimilar) Treatment in Patients with Moderate-to-Severe Psoriasis from the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR))Abstract ID: 4782 Poster ID: P2569 Poster Open Date/Time: Oct 11, 9:00 AMAuthors: Giampiero Girolomoni, Steven Feldman, Alexander Egeberg, Luis Puig Sanz, Hojung Jung, Younjin Park, Younju Lee 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 biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, endocrinology and gastroenterology. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn. References:___________________ 1 Stelara is a trademark of Janssen Pharmaceuticals. 2 Humira is a trademark of AbbVie Biotechnology Ltd. 3 2022 Q3 Biogen Earnings presentation.

Phase 3Clinical ResultDrug ApprovalLicense out/in

02 Aug 2023

·firstwordpharma.com

Samsung Bioepis mulling purchase of Biogen's biosimilars unit: reports

Samsung Bioepis has been in talks to take over Biogen's biosimilars business, according to industry sources cited in South Korean media reports. Sources indicated that through a potential deal, estimated to be worth below KRW 1 trillion ($768 million), Samsung Bioepis is looking to secure a direct sales network in the US and Europe.Biogen said earlier this year alongside its fourth-quarter financial results that a formal process was under way to evaluate strategic options for the unit, which posted $751 million in revenue in 2022. Last week, the company reported that its biosimilar sales were essentially flat in the second quarter at $195 million. The latest rumours come amid ongoing restructuring efforts by Biogen, including the loss of 1000 more jobs by 2025, to trim costs as it continues with the launch of the Alzheimer's disease drug Leqembi in the US.Biogen initially took a 15% stake in Samsung Bioepis when it was established as a joint venture with Samsung Biologics in 2012. It boosted its holding to almost 50% in 2018, until Samsung Biologics acquired Biogen's stake last year through a $2.3-billion deal. Despite no longer holding shares, Biogen has remained a partner responsible for sales of Samsung Bioepis' biosimilar products, including Benepali (etanercept), Imraldi (adalimumab), Flixabi (infliximab) and Byooviz (ranibizumab). It also owns rights to Bio-Thera Solutions' BAT1806, a biosimilar referencing Roche's Actemra (tocilizumab).In a statement, a Samsung Bioepis official said that "when it comes to the acquisition, nothing has been set," and also denied news reports that the company had completed due diligence. "We are reviewing various strategies to secure our biosimilar production capability at a global level and are now focusing on expanding our R&D on competitive pipelines and our sales networks," the official said.Meanwhile, Samsung Bioepis' commercial partner Organon recently began US sales of Hadlima, a biosimilar referencing AbbVie's Humira (adalimumab). Earlier this week, Samsung Bioepis and Organon said that its studies of Hadlima, also known as SB5, showed that the biosimilar can be interchangeable with Humira. An official at Samsung Bioepis indicated that an interchangeability designation would be sought from the FDA soon.

AcquisitionDrug Approval

100 Deals associated with Etanercept-YKRO(Samsung Bioepis Co., Ltd.)

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KEGG	Wiki	ATC	Drug Bank
-	-	L04AB01	DB00005

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Polyarticular Juvenile Idiopathic Arthritis	US	Samsung Bioepis Co., Ltd.	25 Apr 2019
Ankylosing Spondylitis	EU	Samsung Bioepis Co., Ltd.	13 Jan 2016
Ankylosing Spondylitis	IS	Samsung Bioepis Co., Ltd.	13 Jan 2016
Ankylosing Spondylitis	LI	Samsung Bioepis Co., Ltd.	13 Jan 2016
Ankylosing Spondylitis	NO	Samsung Bioepis Co., Ltd.	13 Jan 2016
Axial Spondyloarthritis	EU	Samsung Bioepis Co., Ltd.	13 Jan 2016
Axial Spondyloarthritis	IS	Samsung Bioepis Co., Ltd.	13 Jan 2016
Axial Spondyloarthritis	LI	Samsung Bioepis Co., Ltd.	13 Jan 2016
Axial Spondyloarthritis	NO	Samsung Bioepis Co., Ltd.	13 Jan 2016
Enthesitis-Related Arthritis	EU	Samsung Bioepis Co., Ltd.	13 Jan 2016
Enthesitis-Related Arthritis	IS	Samsung Bioepis Co., Ltd.	13 Jan 2016
Enthesitis-Related Arthritis	LI	Samsung Bioepis Co., Ltd.	13 Jan 2016
Enthesitis-Related Arthritis	NO	Samsung Bioepis Co., Ltd.	13 Jan 2016
Non-radiographic axial spondyloarthritis	EU	Samsung Bioepis Co., Ltd.	13 Jan 2016
Non-radiographic axial spondyloarthritis	IS	Samsung Bioepis Co., Ltd.	13 Jan 2016
Non-radiographic axial spondyloarthritis	LI	Samsung Bioepis Co., Ltd.	13 Jan 2016
Non-radiographic axial spondyloarthritis	NO	Samsung Bioepis Co., Ltd.	13 Jan 2016
Oligoarticular Arthritis	EU	Samsung Bioepis Co., Ltd.	13 Jan 2016
Oligoarticular Arthritis	IS	Samsung Bioepis Co., Ltd.	13 Jan 2016
Oligoarticular Arthritis	LI	Samsung Bioepis Co., Ltd.	13 Jan 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2021	Not Applicable	-	342	Biosimilar SB4 (BS-ETA)	rwnysqnqvi(kfovetxtfx) = iottmxmmfw ldktxewksu (cifihvhuut )	-	02 Jun 2021
Pubmed \| Arthritis Rheumatol	Not Applicable	-	642	Originator Etanercept	dlmnowvaqj(ucvirscmgv): adjusted hazard ratio = 1.57 (95% CI, 1.05 - 2.36)	-	01 Sep 2018
				Biosimilar SB4
BIO-SPAN (EULAR2018)	Not Applicable	-	642	Originator etanercept (ENB)	dnzcecftci(ljfpfplgwd) = 47% vs 28% lqnykvxkfa (foqphyobcu ) View more	Positive	13 Jun 2018
				Biosimilar etanercept (SB4)
NCT01895309 (Pubmed \| Rheumatology (Oxford)) Manual	Phase 3	Rheumatoid Arthritis	596	SB4	dxvbkdowtg(cuhudrlxzy) = mtvciuljuv juffxrukcn (pwkzamtntt ) View more	Similar	01 Dec 2017
				etanercept	dxvbkdowtg(cuhudrlxzy) = yydowenafd juffxrukcn (pwkzamtntt ) View more
BIO-SPAN (ACR2017)	Not Applicable	Rheumatic Diseases	625	Originator Etanercept (ENB)	pmjulvpxlf(oyvbphyrfs) = udqjmemwyw jagdxpnxav (frjijhmcyu, 90% - 94%)	Negative	07 Nov 2017
				Biosimilar SB4	pmjulvpxlf(oyvbphyrfs) = uhdyqusphp jagdxpnxav (frjijhmcyu, 88% - 93%)
NCT01895309 (Pubmed)	Phase 3	Rheumatoid Arthritis	245	SB4	lhwvwhkewh(pegibhzbsz) = resqqtljaa wyafsovgzn (pmfsaakzuz )	-	09 Aug 2017
phase III study comparing SB4 (ETANERCEPT BIOSIMILAR) with reference etanercept in patients with rheumatoid arthritis (EULAR2017)	Phase 3	Rheumatoid Arthritis anti-drug antibody (ADA) \| injection site reaction (ISR)	-	SB4	oonrjdqopq(mwwoztqjkq) = fzlxefzpny ajkijwmulj (hxnwzkajrh ) View more	Positive	14 Jun 2017
				ETN	oonrjdqopq(mwwoztqjkq) = hajkeylfgz ajkijwmulj (hxnwzkajrh ) View more
EULAR2017	Phase 3	Rheumatoid Arthritis Maintenance	551	SB4	wljkdxpfez(pentbtsvdq) = haoaozpaba xpzxravuyy (tcahgmjapf ) View more	Positive	14 Jun 2017
				Reference Etanercept	wljkdxpfez(pentbtsvdq) = tgkdsoidzg xpzxravuyy (tcahgmjapf ) View more
NCT01895309 (Pubmed \| Arthritis Rheumatol) Manual	Phase 3	Rheumatoid Arthritis	596	SB4	ugbzsbkpbc(ktxnsfhkgc) = ogsdbuinyj lcdsjfwvrc (ybnxytodji ) View more	Similar	01 Jan 2017
				etanercept	ugbzsbkpbc(ktxnsfhkgc) = fznaamvxnk lcdsjfwvrc (ybnxytodji ) View more
NCT01895309 (CTgov)	Phase 3	Rheumatoid Arthritis	596	SB4 (proposed biosimilar to etanercept) (SB4 (Proposed Biosimilar to Etanercept))	nidplooepq(udcfycgnjj) = cwwomdykww lmixlbakjy (xgzepzyveq, mggtffhqjw - xzwfldbugd) View more	-	29 Aug 2016
				Enbrel (etanercept) (Enbrel (Etanercept))	nidplooepq(udcfycgnjj) = swrgiqxxcm lmixlbakjy (xgzepzyveq, uciepwzaub - yzdxvuyeht) View more

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