Delving into the Latest Updates on Infliximab-dyyb (Celltrion) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Anti-TNF alpha Mab, Anti-TNF alpha monoclonal antibody, Infliximab Biosimilar (Celltrion, Inc.)

+ [14]

Target

TNF-α

Action

inhibitors

Mechanism

TNF-α inhibitors(Tumor necrosis factor α inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesCardiovascular Diseases+ [6]

Active Indication

Behcet's uveitisErythrodermic psoriasisPsoriasis vulgaris+ [16]

Inactive Indication-

Originator Organization

Celltrion, Inc.

Active Organization

Celltrion Healthcare Hungary Kft

Celltrion, Inc.Pfizer Europe MA EEIG

+ [4]

Inactive Organization-

License Organization

Celltrion, Inc.

Celltrion Healthcare Co., Ltd.

Hospira, Inc.

+ [3]

Drug Highest PhaseApproved

First Approval Date

European Union (10 Sep 2013),

Ankylosing SpondylitisArthritis, PsoriaticColitis, Ulcerative+ [11]

Regulation-

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Structure/Sequence

Sequence Code 69038H

The sequence is quoted from: *****

Group-based trajectory modelling was conducted to deconvolute cohort-level data into individual response trajectories based on longitudinal patient-reported outcomes. Potential predictors of subcutaneous infliximab response were explored using multivariable analyses. Subgroups were compared for clinical, endoscopic, biochemical, and health-related quality of life outcomes; comprehensive disease control (achieving composite endpoints) at week 54; pre-dose serum infliximab levels; and safety.

RESULTS:

Four distinct subgroups of patients were identified: super-responders (rapid and high sustained improvement); fast responders; slow responders; and limited responders (partial improvement). In multivariable analyses, lower baseline body mass index (p = 0.022) and pre-dose serum infliximab levels ≥ 14 μg/ml at week 10 (p = 0.003) were associated with a super-response. At week 54, super-responders showed the highest rates of clinical remission (80.3%; p = 0.002), endoscopic response (63.9%; p = 0.009), health-related quality of life remission (72.1%; p = 0.0002), corticosteroid-free remission (59.1%; p = 0.007), and comprehensive disease control achievement (27.9%; p = 0.014) versus other trajectories. Among groups, super-responders maintained the highest pre-dose serum infliximab levels from week 10. Comparable overall safety profiles were observed across groups.

CONCLUSION:

Distinct subpopulations with varying responses to infliximab were identified by group-based trajectory modelling using longitudinal symptom data, which may support the development of personalised therapy. Super-responders with rapid and sustained improvements during infliximab therapy were more likely to achieve desirable long-term outcomes.

TRIAL REGISTRATION:

ClinicalTrials. gov identifier, NCT03945019 (08 May 2019).

01 Feb 2026·MOLECULAR THERAPY

Extracellular cyclophilin a binding to CD146 is critical for Th17 cell differentiation in rheumatoid arthritis

Article

Author: Pei, Han Zhong ; Liu, Wenjun ; Yuhai Bi ; Lin, Runshan ; Yuna Zhao ; Tingrong Luo ; Jiao, Pengtao ; He Zhang ; Sun, Lei ; Heqiao Li ; Lei Sun ; Pengtao Jiao ; Bai, Xiaoyuan ; Yan, Xiyun ; Xiaoyuan Bai ; Han Zhong Pei ; Zhao, Yuna ; Zhang, He ; Luo, Tingrong ; Wenjun Liu ; Bi, Yuhai ; Li, Heqiao ; Yangtengyu Liu ; Xiyun Yan ; Runshan Lin ; Liu, Yangtengyu ; Hongxia Duan ; Fan, Zeqiu ; Duan, Hongxia ; Xiaoxiao Jia ; Zeqiu Fan ; Jia, Xiaoxiao

Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by joint synovial inflammation. Despite advancements in therapeutic strategies, the critical underlying mechanisms driving RA progression remain incompletely understood, and there is an ongoing need for novel therapeutic targets. We observed that high-level expression of extracellular cyclophilin A (eCypA) in patients with RA was associated with increased disease severity. Anti-CypA monoclonal antibody (mAb) treatment alleviated arthritis in both collagen-induced and collagen antibody-induced arthritis mouse models, outperforming anti-TNF-α mAb therapy. Single-cell RNA sequencing revealed that the anti-CypA mAb inhibited STAT3-mediated Th17 cell differentiation. Mechanistically, the binding of eCypA to the cell-surface receptor CD146 on CD4⁺ T cells promoted STAT3-mediated Th17 cell differentiation by increasing CD146 dimerization. Additionally, conditional CD146 knockout in CD4⁺ T cells suppressed Th17 cell differentiation and alleviated arthritis in a mouse model. In summary, our findings demonstrate that eCypA drives Th17 differentiation in RA by binding to CD146 and that blocking eCypA binding to CD146 is a promising strategy for RA treatment.

01 Jan 2026·Crohns & Colitis 360

Pharmacokinetics and efficacy of subcutaneous infliximab 120 mg every 2 weeks: a post hoc comparison with intravenous dosing in a phase 1 study in patients with inflammatory bowel disease.

Letter

Author: Ben-Horin, Shomron ; Yu, Hyunseong ; Lee, Young Nam ; Ye, Byong Duk ; Kim, Dong-Hyeon ; Schreiber, Stefan

Background:

A phase 1 study of CT-P13 demonstrated pharmacokinetic non-inferiority of subcutaneous (SC) infliximab (IFX) to intravenous (IV) IFX in patients with inflammatory bowel disease. This post hoc analysis aimed to evaluate outcomes in the subset of patients who received IFX SC 120 mg every 2 weeks (Q2W) (eventual approved standard dose).

Methods:

In the phase 1 study (NCT02883452), patients received IFX IV induction therapy at Week (W) 0 and W2 and were randomized at W6 to receive IFX SC 120 mg (for patients weighing <80 kg at W6) or 240 mg (for ≥80 kg) Q2W from W6 through W54, or IFX IV 5 mg/kg every 8 weeks (Q8W) from W6 through W22 and IFX SC 120 mg (for <80 kg at W30) or 240 mg (for ≥80 kg) Q2W from W30 to W54. This analysis included patients weighing <80 kg and thus received IFX SC 120 mg Q2W from W6 (SC 120 mg Q2W subset, n = 48) or W30 (IV 5 mg/kg Q8W subset, n = 45). Intense pharmacokinetic monitoring was used to compare the 2 subsets between W22 and W30.

Results:

Between W23 and W25, serum IFX concentrations in both subsets were within a similar range, but from W25 through W30, patients in the SC 120 mg Q2W subset exhibited higher serum IFX concentrations than in the IV 5 mg/kg Q8W subset, yielding significantly higher drug exposure. Efficacy and safety outcomes were comparable between subsets throughout.

Conclusions:

These data support a favorable pharmacokinetic profile of the approved standard dose of IFX SC.

104

News (Medical) associated with Infliximab-dyyb (Celltrion)

21 Apr 2026

·www.prnewswire.com

Celltrion to present seven abstracts in inflammatory bowel disease (IBD) at 2026 Digestive Disease Week® (DDW)

Seven abstracts accepted for presentation include data from long-term follow-up studies and a post-hoc analysis of the pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) of ZYMFENTRA® (infliximab-dyyb) Findings emphasize clinical decision-making in long-term management of inflammatory bowel disease (IBD), reinforcing Celltrion's commitment to elevating the standard of care and addressing unmet medical need in gastroenterology April 21, 2026 -- Celltrion, Inc. today announced that seven abstracts will be presented at the 2026 Digestive Disease Week® (DDW) Annual Meeting, taking place May 2-5 in Chicago, Illinois. The oral and poster presentations will feature data including post-hoc analysis of its pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) of ZYMFENTRA®, the first and only FDA-approved subcutaneous infliximab. "The findings provide additional evidence that disease control can be effectively recaptured with a convenient subcutaneous option, with the potential to advance the treatment paradigm for people living with Crohn's disease and ulcerative colitis," said Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA. "The research Celltrion is presenting at DDW reflects our ongoing commitment to transforming IBD care through innovative therapies that improve patient outcomes." Celltrion is driving scientific discovery and expanding access to comprehensive clinical and real-world evidence to support informed treatment decisions in an increasingly complex and evolving IBD landscape. ZYMFENTRA® (infliximab-dyyb) is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of moderately-to-severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV), Moderately-to-severely active Crohn's disease following treatment with an infliximab product given by intravenous infusion (IV). ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body. ZYMFENTRA was approved by the FDA through the Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a "stand-alone" BLA). ZYMFENTRA is considered a new biologic with a first-approved subcutaneous administration form and thus will be under patent protection for its dosage form by 2037 and for its route of administration by 2040. Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 2-5, 2026. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba), STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), OMLYCLO® (omalizumab-igec), and EYDENZELT® (aflibercept-boav) as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalClinical Result

20 Mar 2026

·www.pharmamanufacturing.com

Celltrion signs biologics CMO deal, says backlog tops $680M

South Korea’s Celltrion announced a contract manufacturing organization agreement (CMO) with an undisclosed global pharmaceutical company to supply biologic drug substance from 2027 through 2029. According to the announcement, the contract is valued at approximately KRW 294.9 billion (about $200 million) and could increase to KRW 375.4 billion (about $255 million) subject to mutual agreement. Celltrion said it plans to finalize production arrangements early to ensure stable supply. The agreement follows continued momentum in Celltrion’s contract development and manufacturing organization (CDMO) business, including a previously announced contract with Eli Lilly. With the addition of the latest deal, the company said its cumulative CMO order backlog has exceeded KRW 1 trillion (about $680 million USD), reflecting increased demand for its manufacturing capabilities. In November 2025, Celltrion announced plans to expand its U.S. manufacturing capabilities with a $478 million investment in a recently acquired Eli Lilly facility in Branchburg, New Jersey. The expansion at the active pharmaceutical ingredient (API) plant will be rolled out in phases and is aimed at positioning the company to build an integrated U.S.-based manufacturing supply chain. Celltrion’s global manufacturing network includes facilities in Songdo, Incheon and Branchburg, New Jersey, totaling 316,000 liters of capacity. However, the company noted that expanding sales of its own products alongside growing CDMO demand is expected to increase pressure on available capacity, prompting evaluation of additional manufacturing investments. “Global sales of Celltrion’s own products, including Zymfentra, are expected to expand alongside the addition of new pipeline products,” the company said. “Consequently, a significant portion of existing production capacity is likely to be allocated to the manufacturing of Celltrion’s own products. At the same time, rapidly increasing CDMO demand from global pharmaceutical companies is further raising the need for additional manufacturing capacity in the mid- to long term.” Celltrion said it plans to continue expanding its CDMO services, including technology-driven offerings such as formulation conversion, while strengthening global project management and sales capabilities through its subsidiary Celltrion BioSolutions.

Acquisition

18 Mar 2026

·www.prnewswire.com

Celltrion announces U.S. availability of AVTOZMA® (tocilizumab-anoh) subcutaneous (SC) formulation

AVTOZMA® (tocilizumab-anoh) is among the first wave of tocilizumab biosimilars with both intravenous (IV) and subcutaneous (SC) formulations approved and commercially available in the United States The launch of AVTOZMA SC further diversifies Celltrion's immunology portfolio beyond TNF-alpha and IL-12/23 inhibitors providing a broader range of treatment solutions for immune-mediated inflammatory diseases March 16, 2026 -- Celltrion, Inc. today announced that AVTOZMA® (tocilizumab-anoh) subcutaneous (SC) formulation is now commercially available to patients in the United States. With this launch, Celltrion's AVTOZMA becomes one of the first tocilizumab biosimilars to have both an intravenous (IV) and a SC formulation approved by the U.S. Food and Drug Administration (FDA) and available on the U.S. market. "The introduction of AVTOZMA SC is a pivotal moment for Celltrion, underscoring our dedication to delivering effective, accessible and user-friendly therapies for patients with chronic inflammatory diseases," said Thomas Nusbickel, Chief Commercial Officer of Celltrion USA. "By offering both IV and SC formulations, we aim to provide patients and healthcare professionals with greater flexibility in treatment decisions, while continuing to broaden our immunology portfolio with therapies that address diverse inflammatory pathways." The SC formulation of AVTOZMA is indicated for the treatment of rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA). AVTOZMA SC is available in a 162 mg/0.9 mL solution for injection in a single-dose prefilled syringe or a single-dose prefilled autoinjector, allowing patients the flexibility and convenience of administering their treatment at home. [1] Celltrion provides support to U.S. patients prescribed AVTOZMA through its patient support program, Celltrion CONNECT™. Celltrion CONNECT™ offers tailored support to its patients and caregivers with a full range of services including injection training, reimbursement assistance and educational resources to patients and healthcare professionals. AVTOZMA® (tocilizumab-anoh), containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Based on data from the global Phase III clinical trial designed to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of CT-P47 compared to reference tocilizumab, AVTOZMA received approval from the U.S. Food and Drug Administration (FDA) and European Commission (EC) in January and February 2025, respectively. In July 2025, the FDA approved an additional indication for the intravenous (IV) formulation of AVTOZMA for the treatment of cytokine release syndrome (CRS) in adult and pediatric patients aged two years and older. Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (Ustekinumab-stba) STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), and OMLYCLO® (omalizumab-igec), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalImmunotherapy

100 Deals associated with Infliximab-dyyb (Celltrion)

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External Link

KEGG	Wiki	ATC	Drug Bank
D02598	-	L04AB02	DB00065

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Behcet's uveitis	Japan	Nippon Kayaku Co., Ltd.	01 Apr 2020
Erythrodermic psoriasis	Japan	Celltrion, Inc.	22 Jul 2015
Erythrodermic psoriasis	Japan	Nippon Kayaku Co., Ltd.	22 Jul 2015
Psoriasis vulgaris	Japan	Nippon Kayaku Co., Ltd.	22 Jul 2015
Psoriasis vulgaris	Japan	Celltrion, Inc.	22 Jul 2015
Pustular psoriasis	Japan	Celltrion, Inc.	22 Jul 2015
Pustular psoriasis	Japan	Nippon Kayaku Co., Ltd.	22 Jul 2015
Ankylosing Spondylitis	European Union	Pfizer Europe MA EEIG	10 Sep 2013
Ankylosing Spondylitis	European Union	Celltrion Healthcare Hungary Kft	10 Sep 2013
Ankylosing Spondylitis	Iceland	Celltrion Healthcare Hungary Kft	10 Sep 2013
Ankylosing Spondylitis	Iceland	Pfizer Europe MA EEIG	10 Sep 2013
Ankylosing Spondylitis	Liechtenstein	Celltrion Healthcare Hungary Kft	10 Sep 2013
Ankylosing Spondylitis	Liechtenstein	Pfizer Europe MA EEIG	10 Sep 2013
Ankylosing Spondylitis	Norway	Pfizer Europe MA EEIG	10 Sep 2013
Ankylosing Spondylitis	Norway	Celltrion Healthcare Hungary Kft	10 Sep 2013
Arthritis, Psoriatic	European Union	Celltrion Healthcare Hungary Kft	10 Sep 2013
Arthritis, Psoriatic	European Union	Pfizer Europe MA EEIG	10 Sep 2013
Arthritis, Psoriatic	Iceland	Pfizer Europe MA EEIG	10 Sep 2013
Arthritis, Psoriatic	Iceland	Celltrion Healthcare Hungary Kft	10 Sep 2013
Arthritis, Psoriatic	Liechtenstein	Celltrion Healthcare Hungary Kft	10 Sep 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Autoimmune Diseases	Preclinical	United Kingdom	Intract Pharma Ltd.	20 Aug 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04990258 (PEREM, Company_Website) Manual	Not Applicable	Inflammatory Bowel Diseases	136	subcutaneous infliximab (IV → SC switch)	nuocyhcnxe(yvadzhjxnq) = The switch from IV infliximab to SC infliximab is well tolerated amongst patients. ccuwhdwhkb (cswaebtbfo ) View more	Positive	06 Oct 2025
				subcutaneous infliximab + immunomodulator
NCT04205643 \| NCT03945019 (LIBERTY, Pubmed \| J Crohns Colitis)	Phase 3	Perianal fistula due to Crohn's disease \| Colitis, Ulcerative Maintenance	-	CT-P13 SC 120 mg	npuguvkrft(vssctfjnit) = tfbqwdkuqu wlybyjaavo (xphxbhmwvy ) View more	Positive	04 Jun 2025
UEGW2024	Not Applicable	Inflammatory Bowel Diseases	-	CT-P13 SC 120 mg	chksfhtkwt(npznpioqrd) = In UC, 84.7% (61/72) vs 78.1% (132/169), In CD, 86.8% (33/38) vs 79.7% (118/148) mcfdhprglb (rsbcbslxsh ) View more	-	13 Oct 2024
				CT-P13 SC 240 mg
NCT02883452 (Pubmed \| Dig Liver Dis)	Phase 1	Inflammatory Bowel Diseases	112	CT-P13 SC maintenance group	wivhevyrjg(gqsgerfurx) = Similar xxqdgfdfed (flbwupwlzr ) View more	Positive	01 Jul 2024
				IV-to-SC switch group
NCT04205643 \| NCT03945019 (Pubmed) Manual	Phase 3	Crohn Disease \| Inflammatory Bowel Diseases \| Colitis, Ulcerative Maintenance	-	CT-P13 SC 120 mg	wpurxlxbqb(hogskgxkpt) = fjklqozymy bsgeriwzbz (qsdpdancqz ) View more	Positive	23 May 2024
				Placebo	wpurxlxbqb(hogskgxkpt) = hdatwtybvb bsgeriwzbz (qsdpdancqz ) View more
ECCO2024	Not Applicable	Perianal fistula due to Crohn's disease	20	Subcutaneous IFX (CT-P13)	rxoqrjbcba(xhpwaqvvft) = oedpxynpgc ifgoaxfzhn (izoxtgchuy ) View more	Positive	21 Feb 2024
LIBERTY-CD (ECCO2024)	Phase 3	Perianal fistula due to Crohn's disease Maintenance	180	CT-P13 SC	uogsspllqu(tkrevnooxm) = There was no new safety issue reported during the extension phase. melheepbkg (ccphwenuic )	Positive	21 Feb 2024
NCT04205643 (LIBERTY-UC, ECCO2024)	Phase 3	Colitis, Ulcerative	237	CT-P13 SC	kxtafammeu(soxfkmlstc) = qfkavqlctu edsvehklbw (lrbtqwvpul ) View more	Positive	21 Feb 2024
NEWS Manual	Phase 3	Crohn Disease \| Colitis, Ulcerative	-	CT-P13 SC (Crohn's disease)	lxisoqjecy(nbdtgumfyr) = The recommended dose for subcutaneous infliximab is 120 mg once every 2 weeks tjsiwtbirz (lpjszcloxu ) View more	Positive	16 Oct 2023
				CT-P13 SC (ulcerative colitis)
UEGW2023	Not Applicable	Inflammatory Bowel Diseases	-	5 mg/kg every 8 weeks	confydmgvy(nuwcymktjz) = dtejenqxaz ayltycxwea (qzunetdexc ) View more	-	15 Oct 2023
				10 mg/kg every 8 weeks	confydmgvy(nuwcymktjz) = vnscfltton ayltycxwea (qzunetdexc ) View more

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