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]

ACTRN12618000279224

/ CompletedPhase 4

An Assessor-blind, randomised, parallel non-inferiority trial to compare multiple switching of Brenzys® (etanercept biosimilar) and Enbrel® (etanercept reference product) versus non-switching Enbrel® in maintaining efficacy of Enbrel® in participants with rheumatoid arthritis

Start Date19 Apr 2018

Sponsor / Collaborator-

NCT03470688

/ Unknown statusNot Applicable

An Observational Study Designed to Investigate the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents in Australian Rheumatology

An observational study investigating the utilisation and effectiveness of originator and biosimilar anti-TNF agents in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.

Start Date01 Mar 2018

Sponsor / Collaborator

Opal Rheumatology Ltd.

[+1]

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.)

105

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

01 Apr 2025·International Journal of Biological Macromolecules

Schiff bases of cellulose: Synthesis, characterization, and anticancer potency against hepatocellular carcinoma

Article

Author: Khattab, Samar A ; Radwan, Aliaa M ; Kenawy, El-Refaie ; Azaam, Mohamed M ; Kenawy, Marwa E ; Abosharaf, Hamed A ; Tenhu, Heikki

The development of innovative anticancer agents with minimal side effects is crucial. Polymeric Schiff bases have unique features that make them a promising option for therapeutic uses. They are well known for their biological properties, especially anticancer activity. Therefore, the current report describes the synthesis of Schiff bases derived from microcrystalline cellulose. Cellulose Schiff bases were synthesized through three steps. First, cellulose was periodate oxidized to produce dialdehyde cellulose (DAC). Afterwards, DAC was grafted with hyper-branched polyethylenimine (hPEI) to obtain aminated cellulose. Schiff bases were obtained by reacting hPEI-cellulose with various aldehydes. The final products were characterized by spectroscopic and thermal methods. The cellulose Schiff bases were evaluated for their anticancer activities, and it was observed that they were able to inhibit the growth of different types of cells. Importantly, one of the cellulose derivatives (SB4), which contains trimethoxy benzaldehyde moieties, was capable of inducing cell cycle arrest and apoptosis in hepatocellular carcinoma cells (Hep G2). Interestingly, SB4 could act as a pro-oxidant by inducing reactive oxygen species and oxidative stress with notable decline in the antioxidant system within Hep G2 cells. The results displayed that cellulose-based Schiff bases may offer a new strategy for liver cancer therapy.

01 Jan 2025·Carbohydrate Polymers

Inclusion complexes of novel formyl chromone Schiff bases with β-Cyclodextrin: Synthesis, characterization, DNA binding studies and in-vitro release study

Article

Author: Khanna, Pankaj ; Yadav, Shilpa ; Khanna, Leena ; Mansi ; Singh, Asmita

The present study involved the synthesis of five novel Schiff bases (SB1-SB5) of formyl chromone and their inclusion complexes with β-cyclodextrin through kneading approach to enhance the solubility and stability of SBs. Characterization was conducted using FTIR, NMR, SEM, TEM, p-XRD, and Mass Spectrometry. UV fluorescence and pH stability studies confirmed the formation of the inclusion complex. Structural validation of complexes was conducted via molecular docking (PDB ID: 1BFN) and 50 ns MD simulation study. DFT studies were performed on SBs using B3LYP/6-31 + G(d,p) basis set. All SBs exhibited favorable ADME properties and high binding interactions were observed in molecular docking with ctDNA (PDB Id: 1BNA). Further, in-vitro UV absorption and fluorescence experiments demonstrated strong ctDNA interactions for all Schiff bases, with binding constants in the order of 10⁵ M^-1, indicating groove binding mode. Among the SBs, SB4 exhibited the highest affinity for DNA grooves, with a binding constant (K_b) of 1.7 × 10⁶ M^-1. However, the SB4/β-Cyd inclusion complex also interacted with DNA but with low binding constants compared to SB4. An in-vitro release study of SB4/β-Cyd, revealed 78.92 % dissolution of the inclusion complex, highlighting its potential for enhanced solubility and stability in biological systems.

01 Sep 2024·Arthritis Care & Research

Comparative Effectiveness and Persistence of SB4 and Reference Etanercept in Patients With Psoriatic Arthritis in Norway

Article

Author: Brekke, Lene Kristin ; Pripp, Are Hugo ; Bakland, Gunnstein ; Haugeberg, Glenn ; Łosińska, Katarzyna ; Wierød, Ada ; Fevang, Bjørg‐Tilde Svanes ; Korkosz, Mariusz

ObjectiveWe aim to compare drug effectiveness and persistence between the reference etanercept (ETN) and ETN biosimilar SB4 in patients with psoriatic arthritis (PsA) naive to ETN and to investigate drug effectiveness and persistence in those undergoing a mandatory nonmedical switch from ETN to SB4.MethodsWe used a retrospective comparative database study including 1,138 patients with PsA treated with ETN or SB4 (years 1999–2021) in Norway. Disease activity score in 28 joints (DAS28) and drug persistence were compared between unmatched ETN (n = 644) and SB4 (n = 252) cohorts and in matched analyses (n = 144, both cohorts) at baseline using a propensity score (PS) to adjust for confounders. Drug persistence was analyzed with the Kaplan‐Meier method.ResultsIn unmatched analyses, difference in change from baseline between ETN (n = 140) and SB4 (n = 132) for DAS28 at one year was mean 0.67 (95% confidence interval [CI] 0.38–0.96) in favor of ETN. In PS‐matched analyses, the difference in change from baseline between ETN (n = 54) and SB4 (n = 54) was mean 0.09 (95% CI −0.33 to 0.50), and the mean difference assessed with an analysis of covariance model was 0.01 (95% CI −0.38 to 0.40), both within predefined equivalence margin (±0.6). Drug persistence at one year was mean 0.75 (95% CI 0.71–0.78) for ETN, mean 0.58 (95% CI 0.51–0.63) for SB4, hazard ratio (HR) 2.45 (95% CI 2.02–2.97) in unmatched analysis, and mean 0.55 (95% CI 0.46–0.63) for ETN, mean 0.60 (95% CI 0.51–0.67) for SB4, HR 1.29 (95%CI 0.94–1.76) in PS‐matched cohorts.ConclusionAt one year, outcomes for PsA disease activity and drug persistence were comparable for patients treated with either ETN or SB4. In patients undergoing a mandatory nonmedical switch from ETN to SB4, drug effectiveness was maintained during a two‐year period.

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

18 Nov 2024

·pipelinereview.com

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

Phase 3Clinical ResultDrug ApprovalLicense out/in

18 Nov 2024

·investors.biogen.com

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

OPUVIZ™ is one of the first wave aflibercept biosimilars in Europe OPUVIZ is the second European Commission (EC)-approved ophthalmology biosimilar under Samsung Bioepis and Biogen’s partnership EC approval based on robust totality of evidence confirming biosimilarity to reference aflibercept in terms of quality, efficacy, and safety INCHEON, Korea and CAMBRIDGE, Mass. – November 18, 2024 – 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 Eylea1,2 (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 study3,4 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. Biogen Safe Harbor This news release contains forward-looking statements, including but not limited to those relating to the potential benefits, safety and efficacy of OPUVIZ; the timing and status of current and future regulatory filings; risks and uncertainties associated with drug development and commercialization, including OPUVIZ; the potential of Biogen’s commercial business and pipeline programs, including BYOOVIZ, BENEPALI, IMRALDI, FLIXABI and OPUVIZ; the anticipated benefits and potential of Biogen’s collaboration arrangements with Samsung Bioepis; and Biogen’s strategy and plans. These forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, actual timing and content of submissions to and decisions made by the regulatory authorities regarding OPUVIZ; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of OPUVIZ; risks of unexpected costs or delays or other unexpected hurdles; uncertainty of success in the development and potential commercialization of OPUVIZ, which may be impacted by, among other things, the level of preparedness of healthcare providers to treat patients, difficulties in obtaining or changes in the availability of reimbursement for OPUVIZ and other unexpected difficulties or hurdles; the occurrence of adverse safety events; unexpected concerns that may arise from additional data or analysis; failure to protect and enforce data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; risks of legal actions, regulatory scrutiny or other challenges to biosimilars, results of operations and financial condition; product liability claims; and third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements. References: ### MEDIA CONTACT(S): Biogen Jack Cox + 1 781 464 3260 public.affairs@biogen.com Samsung Bioepis Anna Nayun Kim nayun86.kim@samsung.com Yoon Kim yoon1.kim@samsung.com INVESTOR CONTACT: Biogen Stephen Amato +1 781 464 2442 IR@biogen.com

Phase 3Clinical ResultDrug ApprovalLicense out/in

20 Sep 2024

·pipelinereview.com

Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Aflibercept Biosimilar, OPUVIZ™

INCHEON, South Korea and CAMBRIDGE, MA, USA I September 20, 2024 I Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for OPUVIZ™ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea 2 (aflibercept), also known as SB15. OPUVIZ has been recommended for approval 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). “We are pleased to have our second ophthalmology biosimilar OPUVIZ recommended for approval in Europe. This marks another significant milestone for Samsung Bioepis and more importantly for people living with retinal disorders as we are making a step forward in enhancing the availability of the essential treatment,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “The positive opinion underscores not only our commitment to innovation but also ensuring access so that more patients can benefit from biologic therapies. We will continue our work to transform the way biologic therapies are brought to patients and enhance the lives of patients, through our pioneering and innovative use of science and technology,” she added. “We are excited about the positive CHMP recommendation for OPUVIZ in Europe and the potential for it to serve as a meaningful therapeutic option for individuals impacted by retinal vascular disorders,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “Biosimilars could help broaden access and offer significant healthcare savings through the treatment of these complex and often debilitating ophthalmic diseases.” The CHMP’s positive opinion 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 This CHMP’s positive opinion will now be referred to the European Commission (EC) which will decide whether to grant a marketing authorization for OPUVIZ. If a marketing authorization is granted by the EC, OPUVIZ would become 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, Japan and Australia. About the SB15 Phase 3 study 3 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 . SOURCE: Samsung Bioepis

Phase 3Clinical ResultLicense out/inDrug Approval

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

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB01	DB00005

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Ankylosing Spondylitis	Liechtenstein	Samsung Bioepis Co., Ltd.	13 Jan 2016
Ankylosing Spondylitis	Iceland	Samsung Bioepis Co., Ltd.	13 Jan 2016
Ankylosing Spondylitis	Norway	Samsung Bioepis Co., Ltd.	13 Jan 2016
Axial Spondyloarthritis	European Union	Samsung Bioepis Co., Ltd.	13 Jan 2016
Axial Spondyloarthritis	Iceland	Samsung Bioepis Co., Ltd.	13 Jan 2016
Axial Spondyloarthritis	Liechtenstein	Samsung Bioepis Co., Ltd.	13 Jan 2016
Axial Spondyloarthritis	Norway	Samsung Bioepis Co., Ltd.	13 Jan 2016
Oligoarticular Arthritis	Norway	Samsung Bioepis Co., Ltd.	13 Jan 2016
Oligoarticular Arthritis	Liechtenstein	Samsung Bioepis Co., Ltd.	13 Jan 2016
Oligoarticular Arthritis	European Union	Samsung Bioepis Co., Ltd.	13 Jan 2016
Oligoarticular Arthritis	Iceland	Samsung Bioepis Co., Ltd.	13 Jan 2016
Plaque psoriasis	Iceland	Samsung Bioepis Co., Ltd.	13 Jan 2016
Plaque psoriasis	Norway	Samsung Bioepis Co., Ltd.	13 Jan 2016
Plaque psoriasis	Liechtenstein	Samsung Bioepis Co., Ltd.	13 Jan 2016
Plaque psoriasis	European Union	Samsung Bioepis Co., Ltd.	13 Jan 2016
Arthritis, Psoriatic	South Korea	Samsung Bioepis Co., Ltd.	07 Sep 2015
Juvenile Idiopathic Arthritis	South Korea	Samsung Bioepis Co., Ltd.	07 Sep 2015
Psoriasis	South Korea	Samsung Bioepis Co., Ltd.	07 Sep 2015
Rheumatoid Arthritis	South Korea	Samsung Bioepis Co., Ltd.	07 Sep 2015
Spondylometaphyseal Dysplasia, Axial	South Korea	Samsung Bioepis Co., Ltd.	07 Sep 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


COMPANION-B (Pubmed) Manual	Not Applicable	Rheumatoid Arthritis	163	SB4	(xifttfmlje) = jumyxvretj nwwsfzdvlp (kjcweemsyo, 8.4 - 30.9) View more	Positive	22 Sep 2022
				etanercept	(xifttfmlje) = ygdyhdipyn nwwsfzdvlp (kjcweemsyo, 15.0 - 32.2) View more
EULAR2020	Not Applicable	Arthritis	477	Etanercept originator	(fxkszxwnaa) = ahczxrnyge cxdsruuczq (usjiavgvbp ) View more	-	03 Jun 2020
				SB4	(fxkszxwnaa) = nyxnixuutg cxdsruuczq (usjiavgvbp ) View more
EULAR2019	Not Applicable	Maintenance	8,149	Etanercept	(zgvssjhnfb) = ypcukgaomr dhecoyqymg (agjfxqobxr )	-	12 Jun 2019
				SB4	(kclgbruyfi) = swzpjrtahv qrwzlkpzkg (iltqhvohew, 65 - 79)
ACR2018	Not Applicable	Rheumatoid Arthritis	-	Originator Etanercept	leijoalapq(uelpozhxxb) = zistrvswvn xbvjwjfuvs (gkvopbplae, 110 - 2131)	-	24 Oct 2018
				Biosimilar SB4	leijoalapq(uelpozhxxb) = rievjjslic xbvjwjfuvs (gkvopbplae, 272 - 2293)
EULAR2018	Not Applicable	Arthritis	1,641	Originator Etanercept	(lxzqyokjwz) = No major safety events occurred iynsdurciw (tqydelyivv ) View more	-	13 Jun 2018
				Biosimilar SB4
NCT01895309 (Pubmed \| Rheumatology (Oxford)) Manual	Phase 3	Rheumatoid Arthritis	596	SB4	(qypihmlgbn) = rtwkylmelr kksxixskcl (vzhvktplpj ) View more	Similar	01 Dec 2017
				etanercept	(qypihmlgbn) = nwjpowwkyk kksxixskcl (vzhvktplpj ) View more
BIO-SPAN (ACR2017)	Not Applicable	Rheumatic Diseases	625	Originator Etanercept (ENB)	snqfklxlhx(ymlrlsdxdr) = sqplornqkj ojsfximfgu (rdesrtuahk, 90% - 94%)	Negative	07 Nov 2017
				Biosimilar SB4	snqfklxlhx(ymlrlsdxdr) = zvghysenwo ojsfximfgu (rdesrtuahk, 88% - 93%)
NCT01895309 (Pubmed \| Ann Rheum Dis)	Phase 3	Rheumatoid Arthritis	245	SB4	(lnqjwbnqgn) = jtomhcdmta rllukrihre (tfwulcpsec )	-	09 Aug 2017
EULAR2017	Phase 3	Rheumatoid Arthritis Maintenance	551	SB4	(pfuuiplmsa) = nipbeyyfmt wbamxilivr (zmunqmhtyq ) View more	Positive	14 Jun 2017
				Reference Etanercept	(pfuuiplmsa) = endnjgzjvz wbamxilivr (zmunqmhtyq ) View more
EULAR2017	Phase 3	Rheumatoid Arthritis anti-drug antibody (ADA) \| injection site reaction (ISR)	-	SB4	(yeevdiilcz) = zsidkhdjeg npipzijvun (qorbnjxilg ) View more	Positive	14 Jun 2017
				ETN	(yeevdiilcz) = phhzymltyk npipzijvun (qorbnjxilg ) View more

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