A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB2 compared to Remicade in subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy.

Start Date01 Aug 2013

Sponsor / Collaborator

Samsung Bioepis Co., Ltd.

NCT01922336

/ CompletedPhase 1

A Randomised, Single-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Infliximab (SB2, EU Sourced Remicade® and US Sourced Remicade®) in Healthy Subjects

The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy subjects.

Start Date01 Jul 2013

Sponsor / Collaborator

Samsung Bioepis Co., Ltd.

100 Clinical Results associated with Infliximab-ABDA

100 Translational Medicine associated with Infliximab-ABDA

100 Patents (Medical) associated with Infliximab-ABDA

150

Literatures (Medical) associated with Infliximab-ABDA

14 Jul 2026·ACS Omega

The Development of Green Schiff Base-Coated Papers Using Empty Palm Fruit Bunch Biomass for Enhanced Wet Strength

Article

Author: Damanik, Fadhila Natania ; Sapitri, Andira ; Doloksaribu, Rahel Argana ; Shuwanto, Hardy ; Saragih, Gimelliya ; Sitinjak, Elvri Melliaty ; Hutajulu, Poltak Evencus ; Sihaloho, Leo Frengki ; Dina, Sari Farah ; Hutapea, Rahel Gabriel Sionita ; Siahaan, Immanuel ; Pakpahan, Verianto ; Masmur, Indra ; Ardela, Septriasi Sarah

In this study, a sustainable cellulose-based Schiff base wet strength agent (WSA) was successfully synthesized from empty palm fruit bunch (EPFB) biomass. Cellulose isolated from EPFB was oxidized using sodium periodate to produce dialdehyde cellulose (DAC), which was subsequently reacted with six different amine precursors, methylamine (SB-1), ethylenediamine (SB-2), ethylamine (SB-3), diethylamine (SB-4), ethanolamine (SB-5), and diethanolamine (SB-6), to form cellulose-based Schiff base derivatives. Structural characterization by FTIR confirmed the formation of imine (CN) linkages, while XRD revealed a decrease in crystallinity after oxidation and Schiff base formation. SEM analysis demonstrated a progressive morphological transformation from fibrous cellulose to compact and aggregated Schiff base structures. BET results indicated a significant enhancement of the specific surface area, particularly for SB-2 (417.6 m² g^-1), suggesting improved interaction potential with paper fibers. Thermal analysis showed that cross-linked Schiff base structures exhibited modified thermal stability compared to DAC. Mechanical testing demonstrated substantial improvement in wet tensile strength, with SB-2 exhibiting the best performance, approaching that of commercial polyamide epichlorohydrin (PAE) agents. Biodegradability studies confirmed rapid degradation of all Schiff base samples, achieving nearly complete degradation within 20 days, outperforming conventional synthetic agents. These findings demonstrate that EPFB-derived Schiff base materials offer a promising, biodegradable, and biobased alternative to synthetic wet strength agents in paper applications.

01 Dec 2025·MOLECULAR BIOLOGY REPORTS

Indigenous aseel chicken-derived probiotics as biofactories of antifungal metabolites to control mycotoxin contamination in poultry feed

Article

Author: Khalid, Awais ; Arshad, Muhammad ; Andleeb, Saiqa ; Naseem, Sajida ; Liaqat, Iram ; Muhammad, Noor

BACKGROUND:

Fungal and mycotoxin contamination threaten poultry health, feed safety, and global food security. Mycotoxins result in reduced poultry growth, nutrient absorption, and a compromised immune system, causing severe financial losses. The rise of antibiotic resistance due to excessive antibiotic use in poultry also necessitates alternative strategies.

METHODS AND RESULTS:

Total 28 strains were isolated from the gut of indigenous Aseel and broiler chickens. Strains SB1, SB2, and SD2 completely inhibited Aspergillus flavus, Aspergillus ochraceus, and Fusarium proliferatum and were assessed via spore germination and mycotoxin reduction assays. The strains significantly inhibited fungal spore germination (up to 91.7 ± 0.3%;P ≤ 0.001) and reduced aflatoxin, ochratoxin, and fumonisin production by 91.6 ± 1.2%, 93.6 ± 0.6%, and 93.0 ± 0.5%, respectively. FTIR analysis of bacterial metabolites revealed shifts in peaks at 1467-3240 cm^- 1, indicating the presence of various functional groups. LC-MS/MS metabolomics, supported by multivariate analysis, revealed that metabolites were enriched with antifungal and mycotoxin-reducing compounds, including phenylacetic acid. Metabolites showed zones of inhibition up to 38.0 ± 1.1 mm against A. flavus, up to 36.0 ± 0.5 mm against A. ochraceus, and up to 34.0 ± 0.5 mm ZOI against F. proliferatum (P ≤ 0.0001). They also showed the lowest minimum inhibitory concentrations and fungicidal concentrations between 3 and 5 µLmL^- 1 (P ≤ 0.001). 16 S rRNA sequencing identified SB1 as Bacillus subtilis (PV569530), SB2 as Bacillus clausii (PV569531), and SD2 as Bacillus sp. (PV569532).

CONCLUSION:

Thus, this study highlights the microflora of indigenous Aseel chickens as a potential source of antifungal and mycotoxin-reducing compounds, offering a sustainable approach to control fungal and mycotoxin contamination in poultry feed.

CLINICAL TRIAL NUMBER:

As this study did not involve higher animals, no clinical trial number was required.

01 Aug 2025·Chemistry-An Asian Journal

In Vitro and In Live‐Cell Rapid Hydrazine Detection by Disaggregation of the AIEgen Microstructure

Article

Author: Surajit Singh ; Debasish Haldar ; Pradip Kumar Hansda ; M. Douzapau ; Suman Das

Abstract:

In this study, efficient hydrazine detectors are developed using disaggregation of AIEgen microstructures. A new class of 2,4,6‐triphenylaniline‐based AIEgens are designed to alter the optoelectronic properties in different aggregated states. These 2,4,6‐triphenylaniline‐based molecules (SB1, SB2, and SB3) are self‐assembled in the aqueous medium as well as in physiological condition, creating distinct microdomains and effectively showing tunable aggregation‐ induced emission (AIE) properties. The aggregation behavior was extensively investigated using advanced spectroscopic and microscopic techniques, by modulating the water content in acetonitrile solution. The aggregated state of SB3 emerged as the most sensitive hydrazine detector, achieving an exceptional detection limit of 0.054 µM, outperforming compounds SB1 (2.8 µM) and SB2 (2.2 µM). This attributed to hydrogen bond induced disaggregation of AIEgen aggregates, resulting in a pronounced turn‐on fluorescence response by intramolecular charge transfer (ICT). Not only aqueous hydrazine or hydrazine vapor detection, but also the SB3 permeate cell membrane, localize in the perinuclear area, and detect intracellular hydrazine with great specificity. This on‐site and real‐time fluorogenic hydrazine detection have prospective applications in monitoring the environment and biomedical imaging.

News (Medical) associated with Infliximab-ABDA

18 Jun 2026

·www.biospace.com

Organon and Samsung Bioepis Expand Agreement to Commercialize PYZCHIVA® (ustekinumab), a Biosimilar Referencing STELARA® (ustekinumab) in Canada

The amended agreement deepens Organon and Samsung Bioepis’s collaboration to six biosimilars in Canada across multiple therapeutic areas, including immunology, oncology and dermatology. To be launched in Canada in 2026 INCHEON, South Korea & KIRKLAND, Quebec--(BUSINESS WIRE)--Samsung Bioepis and Organon, a global healthcare company with a deep expertise in biosimilars, announced the expansion of their development and commercialization agreement, whereby Organon will obtain commercialization rights in Canada to PYZCHIVA ® , Samsung Bioepis’s biosimilar referencing STELARA ® (ustekinumab). PYZCHIVA ® is indicated for the treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease who have had an inadequate response, loss of response to, or were intolerant to either immunomodulators or one or more tumour necrosis factor-alpha (TNFα) antagonists, or have had an inadequate response, intolerance or demonstrated dependence on corticosteroids, moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies. Under the terms of the agreement, Organon will obtain exclusive commercial rights to the product in Canada while Samsung Bioepis will maintain full development, manufacturing, and regulatory responsibilities. This agreement expands the biosimilar portfolio under Organon and Samsung Bioepis’s collaboration in Canada from five to six complementary products. The five other products in the collaboration in Canada are HADLIMA ® (adalimumab), BRENZYS ® (etanercept), RENFLEXIS ® (infliximab), AYBINTIO ® (bevacizumab), and ONTRUZANT ® (trastuzumab). PYZCHIVA ® is expected to be launched in the market in 2026. "In Canada, biosimilars have played a significant role in strengthening the financial stability of the healthcare systems by reducing medical expenditure for the governments, hospitals, and patients. Samsung Bioepis is proud to have contributed to making biologic medicines more affordable for all stakeholders. By expanding our commercial partnership with Organon, we hope to create greater synergy in accelerating access to our biologic medicines,” said Jinhan Chung, Vice President and Head of Commercial Strategy for International Markets, Samsung Bioepis. “We will work relentlessly to ensure continued supply of our ustekinumab biosimilar to patients in the Canadian market.” “We’re proud to strengthen our longstanding relationship with Samsung Bioepis one of Organon’s key global collaborators as we continue to work to help expand access to medicines and advance a more sustainable healthcare system,” said Dominic Bégin, President and Managing Director, Organon Canada. “In Canada, we have built a strong foundation in delivering accessible biosimilars for patients, as demonstrated over the past ten years. By leveraging our capabilities and expertise, we see opportunity to expand access to this treatment, helping more patients receive the care they need while providing an important alternative option that supports both healthcare providers and the broader system.” With the addition of PYZCHIVA ® to the Samsung Bioepis and Organon portfolio, the companies reinforce their commitment to delivering more treatment options that can help reduce spending pressures on healthcare systems and expand access to medicines for patients. An estimated 1 in 140 Canadians lives with Crohn’s or colitis, the two main forms of inflammatory bowel disease (IBD), which cause inflammation of the intestines. i Also, it is estimated that one million Canadians are currently living with psoriasis, a chronic inflammatory skin condition that causes red to violet elevated areas of skin (plaques), usually covered with silvery-white scales that can be itchy and painful. Up to 30% of patients with psoriasis have associated psoriatic arthritis. ii For more information about PYZCHIVA ® (ustekinumab) in Canada, including important safety information, visit . 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. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology. For more information, please visit and follow us on LinkedIn and X . About Organon Organon is an independent global healthcare company dedicated to improving the health of women throughout their lives. With a diverse portfolio of over 70 medicines and products in women’s health, biosimilars, and general medicines across a range of therapeutic areas, Organon is committed to innovation and collaboration. Headquartered in Jersey City, New Jersey, with a Canadian office in Kirkland, Quebec, Organon has approximately 10,000 employees worldwide. For more information, visit and connect with us on LinkedIn . Cautionary Note Regarding Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States’ Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about PYZCHIVA ® for the treatment of adult patients with chronic moderate to severe plaque psoriasis and other conditions, as well as statements regarding the expanded commercial launch of that product and other biosimilars in Canada pursuant to the development and commercialization agreement. Forward-looking statements may be identified by words such as “will,” “expected,” and words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the U.S. Securities and Exchange Commission (“SEC”), including Organon’s most recent Annual Report on Form 10-K and other SEC filings, available at the SEC’s Internet site ( ). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. STELARA ® is a trademark registered in Canada in the name of Johnson & Johnson. Organon is not associated with this trademark owner. i Crohn’s and Colitis Canada. Resources and Publications. Available at: . Accessed on June 12, 2026. ii Canadian Dermatology Association. Psoriasis. Available at: . Accessed on June 12, 2026. Contacts Organon Canada Media Contact: media_canada@organon.com Organon Investor Relations: Jennifer Halchak (201) 275-2711 Samsung Bioepis Media Contacts: Yoon Kim, yoon1.kim@samsung.com Anna Nayun Kim, nayun86.kim@samsung.com

License out/inDrug Approval

15 Jan 2026

·www.biospace.com

Samsung Epis Holdings Delivers Business Updates at the 44th J.P. Morgan Healthcare Conference

Samsung Bioepis plans to secure 20 biosimilars in its products and pipeline by 2030 The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab, in addition to pembrolizumab currently in Phase 1 and 3 clinical studies Having secured investigational new drug application (IND) clearance from the U.S. Food and Drug Administration (FDA), SBE303, Samsung Bioepis’ novel antibody-drug conjugate (ADC) engineered to target Nectin-4, will enter into the Phase 1 first-in-human clinical trial this year Samsung Bioepis plans to add one novel therapeutic candidate in clinical study every year INCHEON, Korea--(BUSINESS WIRE)-- #ADC --Samsung Epis Holdings (KRX: 0126Z0) today shared corporate progress and updates at the 44th J.P. Morgan Healthcare Conference. "2026 is a monumental year for us, as we enter into a new chapter for our company. Today, we are announcing six additional candidates in our biosimilar pipeline, including vedolizumab and dupilumab. We are making great progress to secure 20 biosimilars in our portfolio by 2030," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We also received the investigational new drug application (IND) clearance for the first novel therapeutic candidate developed by Samsung Bioepis, and plan to advance our clinical program this year. As we broaden our portfolio beyond biosimilars, we will continue our development efforts in antibody-drug conjugates (ADCs), leveraging our innovative research and development platform to expand viable treatment options for patients with unmet needs.” Samsung Bioepis Biosimilar Updates Samsung Bioepis currently has 11 biosimilars for 10 unique biological molecules approved and launched in more than 40 countries. 1 The company has pembrolizumab biosimilar undergoing Phase 1 and 3 clinical studies, and plans to secure 20 biosimilars in its portfolio by 2030. The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab. Novel Therapeutics Updates In December 2025, the FDA has cleared the IND Application for SBE303. SBE303 is Samsung Bioepis’ first novel ADC engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including urothelial cancer, lung cancer, and breast cancer. 2 The Phase 1 first-in-human clinical trial, aiming to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of SBE303 in participants with advanced refractory solid tumors, is set to begin this year. Samsung Bioepis plans to have one novel therapeutic candidate enter into clinical study every year. Epis NexLab, the new subsidiary under Samsung Epis Holdings, has launched a project to develop a peptide-based drug delivery platform. Samsung Bioepis Biosimilars Portfolio Code Name (Brand Name 3 ) Non-proprietary Name Reference Product Status 4 SB5 (IMRALDI™, HADLIMA™, ADALLOCE™) Adalimumab Humira Launch SB4 (BENEPALI™, BRENZYS™, ETOLOCE™) Etanercept Enbrel Launch SB2 (FLIXABI™, RENFLEXIS™, REMALOCE™) Infliximab Remicade Launch SB3 (ONTRUZANT™, SAMFENET™) Trastuzumab Herceptin Launch SB8 (AYBINTIO™) Bevacizumab Avastin Launch SB11 (BYOOVIZ™, AMELIVU™) Ranibizumab Lucentis Launch SB12 (EPYSQLI™) Eculizumab Soliris Launch SB15 (OPUVIZ™, AFILIVU™) Aflibercept Eylea Launch SB16 (OBODENCE™, OSPOMYV™) Denosumab Prolia Launch SB16 (XBRYK™) Denosumab Xgeva Launch SB17 (PYZCHIVA™, EPYZTEK™) Ustekinumab Stelara Launch SB27 Pembrolizumab Keytruda Phase 1 and 3 Samsung Bioepis Biosimilar Candidates in Early Stage Development Non-proprietary Name Reference Product Dupilumab Dupixent Guselkumab Tremfya Ixekizumab Taltz Vedolizumab Entyvio Ocrelizumab Ocrevus Fam-trastuzumab deruxtecan-nxki Enhertu About Samsung Epis Holdings Co., Ltd. As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings aims to maximize corporate and shareholder value through proactive R&D and investment and optimize business strategies for its subsidiaries, Samsung Bioepis and Epis NexLab. Samsung Epis Holdings continues to embrace future challenges and drive innovation by identifying new growth drivers and strengthening global collaboration platforms, thereby laying a solid foundation for the continued growth of its subsidiaries. For more information about Samsung Epis Holdings, please visit: . 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, nephrology, neurology, and endocrinology. For more information, please visit and follow us on LinkedIn and X . About Epis NexLab Co., Ltd. Established in 2025 as a 100% owned subsidiary of Samsung Epis Holdings, Epis NexLab is committed to driving innovation through the development of next-generation biotechnology platforms. By transforming highly scalable peptide-related technologies into development platforms, Epis NexLab is focused on the discovery of innovative treatment modalities for the development of multiple therapeutic candidates targeting a wide range of diseases. For more information about Epis NexLab, please visit: . 1 “more than 40 countries” signifies countries where Samsung Bioepis has commercial presence, with one or more products. 2 Li K, Zhou Y, Zang M, Jin X, Li X. Therapeutic prospects of nectin-4 in cancer: applications and value. Front Oncol. 2024 Mar 28;14:1354543. doi: 10.3389/fonc.2024.1354543. PMID: 38606099; PMCID: PMC11007101. 3 Different brand names for different regions and countries. 4 “Launch” signifies launch in one or more markets and does not necessarily indicate launch in all markets worldwide Contacts Media Contact Anna Nayun Kim, nayun86.kim@samsung.com Yoon Kim, yoon1.kim@samsung.com

Phase 1INDADC

29 Oct 2025

·www.businesswire.com

Samsung Bioepis to Commercialize BYOOVIZ ® (ranibizumab) in Europe from January 2026

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. announced today that the company has entered into an Asset Purchase Agreement (APA) with Biogen regarding Samsung Bioepis’ two ophthalmology assets: BYOOVIZ® (ranibizumab), a biosimilar referencing Lucentisi (ranibizumab) and OPUVIZ™ (aflibercept), a biosimilar referencing Eyleaii (aflibercept) — in Europe. Samsung Bioepis will have full responsibility for commercialization of BYOOVIZ upon the transfer of commercial rights from Biogen back to Samsung Bioepis, effective as of January 2026. We are pleased to announce our direct commercialization initiative for BYOOVIZ in Europe. We will work closely with Biogen to ensure a seamless transition and the continued delivery of services to our customers and patients in Europe. “We are pleased to announce our direct commercialization initiative for BYOOVIZ in Europe. We will work closely with Biogen to ensure a seamless transition and the continued delivery of services to our customers and patients in Europe,” said Linda Choi MacDonald, Executive Vice President and Global Head of Commercial, at Samsung Bioepis. “Samsung Bioepis will continue to broaden our reach to patients across Europe by reinforcing our leadership and expertise in biosimilars.” BYOOVIZ (ranibizumab) was approved by the European Commission (EC) in August 2021 as the first ophthalmology biosimilar in Europe for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). BYOOVIZ became commercially available in several countries within Europe from March 2023. OPUVIZ (aflibercept) was approved by the EC in November 2024 and by the Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025 for the treatment of patients with Wet AMD, Visual Impairment due to Macular Oedema Secondary to RVO, Visual Impairment due to Diabetic Macular Edema (DME), and Visual Impairment due to mCNV. OPUVIZ will not be launched until after the lapse or revocation of relevant patent(s) for the reference biologic Eylea that also covers OPUVIZ in Europe. 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 – LinkedIn, X. Lucentis is a trademark of Genentech, Inc. Eylea is a trademark of Bayer AG

Drug ApprovalLicense out/in

100 Deals associated with Infliximab-ABDA

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Crohn's disease, active moderate	European Union	Samsung Bioepis Co., Ltd.	26 May 2016
Crohn's disease, active moderate	Iceland	Samsung Bioepis Co., Ltd.	26 May 2016
Crohn's disease, active moderate	Liechtenstein	Samsung Bioepis Co., Ltd.	26 May 2016
Crohn's disease, active moderate	Norway	Samsung Bioepis Co., Ltd.	26 May 2016
Crohn's disease, active severe	European Union	Samsung Bioepis Co., Ltd.	26 May 2016
Crohn's disease, active severe	Iceland	Samsung Bioepis Co., Ltd.	26 May 2016
Crohn's disease, active severe	Liechtenstein	Samsung Bioepis Co., Ltd.	26 May 2016
Crohn's disease, active severe	Norway	Samsung Bioepis Co., Ltd.	26 May 2016
Pediatric Crohn's Disease	European Union	Samsung Bioepis Co., Ltd.	26 May 2016
Pediatric Crohn's Disease	Iceland	Samsung Bioepis Co., Ltd.	26 May 2016
Pediatric Crohn's Disease	Liechtenstein	Samsung Bioepis Co., Ltd.	26 May 2016
Pediatric Crohn's Disease	Norway	Samsung Bioepis Co., Ltd.	26 May 2016
Pediatric Ulcerative Colitis	European Union	Samsung Bioepis Co., Ltd.	26 May 2016
Pediatric Ulcerative Colitis	Iceland	Samsung Bioepis Co., Ltd.	26 May 2016
Pediatric Ulcerative Colitis	Liechtenstein	Samsung Bioepis Co., Ltd.	26 May 2016
Pediatric Ulcerative Colitis	Norway	Samsung Bioepis Co., Ltd.	26 May 2016
Perianal fistula due to Crohn's disease	European Union	Samsung Bioepis Co., Ltd.	26 May 2016
Perianal fistula due to Crohn's disease	Iceland	Samsung Bioepis Co., Ltd.	26 May 2016
Perianal fistula due to Crohn's disease	Liechtenstein	Samsung Bioepis Co., Ltd.	26 May 2016
Perianal fistula due to Crohn's disease	Norway	Samsung Bioepis Co., Ltd.	26 May 2016

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW2020	Not Applicable	-	-	Reference IFX	zbmudunkxx(odbkhldrkv) = Serious adverse events were reported for 5 UC patients (TB, anal fistula, pouchitis, rash, allergic reaction) and 8 CD patients (abscess, subocclusive syndrome, rectal abscess, intestinal obstruction [4 patients], infectious diarrhoea) bezlaulszj (zodpuulnzj )	-	01 Oct 2020
				Biosimilar IFX
PERFUSE (UEGW2019)	Not Applicable	Crohn Disease \| Colitis, Ulcerative anti-infliximab antibodies (ADA)	575	SB2	wgwjszouca(tinutolwpe) = no clinically relevant difference in disease score from baseline to M12 was observed; mean individual change was -0.34 (95% CI -0.72, 0.04) and -0.22 (95% CI -0.89, 0.44) in CD and UC respectively wengpzvchv (bsqszwpumg )	Positive	01 Oct 2019
				IFX originator
NCT01922336 (CTgov)	Phase 1	-	159	EU Remicade (EU Remicade)	kniddsbxby(wobgvarpuq) = axalqtvudx yhclwroqct (dckdfrripy, 12332.41615) View more	-	21 Feb 2019
				US Remicade (US Remicade)	kniddsbxby(wobgvarpuq) = vqdizuxeok yhclwroqct (dckdfrripy, 10064.08853) View more
UEGW2018	Not Applicable	Inflammatory Bowel Diseases	-	Reference infliximab	sogxtqrihp(qqopituzcb) = 3 patients in the Biosimilar SB2 group experienced anaphylaxis qenflodphz (iqnyzrjqwc ) View more	-	01 Oct 2018
				Biosimilar SB2
THU0201 (EULAR2018)	Phase 3	Rheumatoid Arthritis DAS28	1,263	SB4	tnjiuscujg(rilqkrflpd) = ixhfrkcnwq fgmpwdrzjy (pitcqvedhi )	Positive	13 Jun 2018
				SB2	tnjiuscujg(rilqkrflpd) = ndcccduxuw fgmpwdrzjy (pitcqvedhi )
NCT01936181 (Pubmed \| Ann Rheum Dis)	Phase 3	Rheumatoid Arthritis	-	SB2	mowvajzlaw(ubtaiyqtsw) = tchihdbuur bmgxvjbddl (vcmrgnbjiv ) View more	-	01 Feb 2018
				INF	mowvajzlaw(ubtaiyqtsw) = qvstzcrvkm bmgxvjbddl (vcmrgnbjiv ) View more
NCT01936181 (Pubmed \| Arthritis Rheumatol \| Ann Rheum Dis) Manual	Phase 3	Rheumatoid Arthritis	584	SB2	qhmvgixpes(yjxxehjvwk) = nrbudzyfrf nrsqsyafwu (zbaobipwol ) View more	Similar	01 Jan 2017
				infliximab	qhmvgixpes(yjxxehjvwk) = gvddqeklwd nrsqsyafwu (zbaobipwol ) View more
NCT01936181 (CTgov)	Phase 3	Rheumatoid Arthritis	584	SB2 (proposed biosimilar to infliximab) (SB2 (Proposed Biosimilar to Inflixmab))	cxdahcakjh = chconwaopf ikluewmxcr (yyaowrkmcp, dlmwzkteej - ctvkslldzl) View more	-	29 Aug 2016
				Remicade (infliximab) (Remicade (Infliximab))	cxdahcakjh = ycofbniumt ikluewmxcr (yyaowrkmcp, vrlxdxanxz - xqqgljldon) View more
EULAR2016	Phase 3	Rheumatoid Arthritis anti-drug antibody (ADA)	583	SB2	rcydczqvak(yequahjdvn) = orbmcvagtn hympzvexxn (hxttfgufxr )	-	08 Jun 2016
				Infliximab reference product	rcydczqvak(yequahjdvn) = hebkrtlsfz hympzvexxn (hxttfgufxr )
Phase III study comparing SB2, an infliximab biosimilar, to infliximab reference product in patients with rheumatoid arthritis (EULAR2016)	Phase 3	Rheumatoid Arthritis interferon-γ release assay (IGRA)	804	SB2	euiitodjof(ttqjvcmwqq) = xvkfnwkpkx otaqtlsvtr (aovwuzagpo ) View more	Positive	08 Jun 2016
				INF	euiitodjof(ttqjvcmwqq) = hbyfpgsuvf otaqtlsvtr (aovwuzagpo ) View more

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