Yuflyma (adalimumab-aaty) / Celltrion, Hikma - LARVOL DELTA

Celltrion said its autoimmune disease treatments Remsima, Yuflyma, and Steqeyma won a national tender in Portugal. (Chosun Biz)

Commercial • Ankylosing Spondylitis • Crohn's disease • Hidradenitis Suppurativa • Immunology • Plaque Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis • Uveitis

ADAPT: Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial (clinicaltrials.gov) - P4 | N=160 | Not yet recruiting | Sponsor: Nisha Acharya

New P4 trial • Idiopathic Arthritis • Immunology • Ocular Inflammation • Ophthalmology • Pediatrics • Rheumatology • Uveitis

Monitoring CT-P17 (Yuflyma) Drug Levels and Remission Rates in Pediatric Crohn's Disease: A Single Center Observational Preliminary Study (AOCC-IMKASID 2026) - "Background / Aim: Adalimumab (ADL), an anti–tumor necrosis factor agent, is widely used for treating pediatric Crohn's disease (CD). Higher induction-phase ADL TLs showed a trend toward improved long-term ER, though statistical significance was not reached. Larger prospective studies are needed to confirm these findings. Keywords: Adalimumab, Pediatrcs, Crohn's Disease, Trough Level, Endoscopic Remission However, week 2 TL was not an independent predictor of 1-year remission in multivariate analysis."

Clinical • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • Pediatrics • TNFA

Current Status and Treatment Trends of IBD in Korea (AOCC-IMKASID 2026) - "In addition, biosimilars of adalimumab (Adaloce, Yuflyma) and ustekinumab (Epyztek, Steqeyma) became available, improving treatment accessibility and reinforcing the shift toward more cost-effective care. Currently, advanced therapies available in Korean patients with CD are infliximab, adalimumab, vedolizumab, ustekinumab, and upadacitinib, in patients with UC are infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, filgotinib, upadacitinib, and ozanimod. Collectively, these developments broadened therapeutic options and increased the complexity of clinical decision-making, prompting greater interest in treatment sequencing, switching strategies, combination regimens, and personalized approaches."

Inflammatory Bowel Disease

2025.36: Discontinuation of disease-modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis patients also using TNF inhibitors (clinicaltrialsregister.eu) - P4 | N=202 | Not yet recruiting | Sponsor: Sint Maartenskliniek Stichting

Head-to-Head • New P4 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Ocular Risks of Adalimumab Biosimilars Through a National Analysis (ARVO 2026) - "We performed deduplication, case expansion, and classification into original (adalimumab) and biosimilar (adalimumab-aacf, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm adalimumab-afzb, adalimumab-aqvh, adalimumab-atto, adalimumab-bwwd, adalimumab-fkjp, and adalimumab-ryvk). These findings do not prove the drugs cause these issues, but they highlight areas for doctors and patients to watch more closely. Improving our understanding of biosimilar safety helps ensure patients receive effective treatment with the lowest possible risk."

Ophthalmology

PBAC Recommends PBS Reimbursement for Biosimilars to Adalimumab (High Concentration), Omalizumab (PFP) & Ustekinumab (Pearce IP) - "At the March 2026 PBAC Meeting (outcomes published on 24 April 2026), the Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommended reimbursement of the following biosimilars: Amgen’s Amgevita (adalimumab) in 20mg/0.2ml and 40mg/0.4ml pre-filled syringe (PFS), and 40mg/0.4ml and 80mg/0.8ml pre-filled pen (PFP); Celltrion’s Yuflyma (adalimumab) in 20mg/0.2ml PFS; Celltrion’s Omlyclo (omalizumab) in 75mg/0.5ml and 150mg/1ml PFP; Sandoz’s Ardelya (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS; Amgen’s Wezlana (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS and 130 mg in 26 mL solution for IV infusion."

Reimbursement • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Crohn's disease • Hidradenitis Suppurativa • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Celltrion grows Europe share as…autoimmune drugs win tenders, scripts (Chosun Biz) - "The autoimmune disease treatment 'Avtozma' (tocilizumab) was selected as a supplier in tenders for Spain's Basque and Madrid regions and in a tender by INGESA under the Ministry of Health. In Portugal, it secured the top-priority national tender supplier status for both the autoinjector and vial formulations. In Germany, sales of Avtozma are increasing....The expansion of Avtozma sales led to increased prescriptions of 'Yuflyma' (adalimumab). Since Abtozma's launch, Yuflyma has continued to grow about 10% per quarter."

Commercial • Ankylosing Spondylitis • Crohn's disease • Giant Cell Arteritis • Hidradenitis Suppurativa • Idiopathic Arthritis • Psoriasis • Rheumatoid Arthritis • Ulcerative Colitis • Uveitis

Sex Differences in Treatment Expectations, Satisfaction and Tolerance After Switching to CT-P17, an Adalimumab Biosimilar: A Post Hoc Analysis of the YU-MATTER Study. (PubMed, Rheumatol Ther) - P | "Most expectations and perceptions of CT-P17 treatment were similar between sexes, but women experienced more injection site reactions. Further research is needed to understand why women experience a higher incidence of these reactions with adalimumab and its biosimilars."

Journal • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Pain • Rheumatology

…Celltrion's autoimmune disease therapies are also expanding their share in Japan (Chosun Biz) - "The infliximab biosimilar 'Remsima' holds a 43% share in Japan, while the adalimumab biosimilar 'Yuflyma' holds 17%....Celltrion...plans to launch the tocilizumab biosimilar 'Avtozma' in the second quarter of this year."

Biosimilar launch • Commercial • Ankylosing Spondylitis • Crohn's disease • Giant Cell Arteritis • Hidradenitis Suppurativa • Idiopathic Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis • Uveitis

Celltrion announced on the 5th that it has obtained product approval for the 20mg/0.2mL PFS formulation, a low-dose product of the autoimmune disease treatment "Yuflyma" from the Ministry of Food and Drug Safety. (Pulse by Maeil Business News Korea) - "'All 12 indications, including rheumatoid arthritis, psoriasis, and childhood Crohn's disease, have a full lineup from low to high doses, allowing us to provide customized treatment optimized for patients of all ages.'"

Korea approval • Ankylosing Spondylitis • Crohn's disease • Hidradenitis Suppurativa • Idiopathic Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis • Uveitis

Comparative Efficacy and Safety of Advanced Therapies in Maintenance Treatment of Adult Patients with Moderate-to-Severe Crohn's Disease: A Systematic Literature Review and Network Meta-Analysis. (PubMed, Adv Ther) - "The current NMA integrating recently updated phase 3 data in CD indicated that no single treatment significantly outperformed others in achieving clinical remission and endoscopic response, although SC infliximab 120 mg q.2.w exhibited highest numerical efficacy as both a first-line and second-or-later-line maintenance treatment in adult patients with moderate-to-severe CD."

Journal • Retrospective data • Review • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Celltrion said on the 31st that, on a consolidation basis, fourth-quarter sales are tentatively tallied at 1.2839 trillion won, up 20.7% from a year earlier, and operating profit at 472.2 billion won, up 140.4% from a year earlier (Chosun Biz) - "Celltrion said the result was driven by steady growth in existing flagship products and the rapid sales traction of high-margin new products that have settled into the global market. According to the company, new products such as the autoimmune disease treatment Remsima SC (U.S. product name Zymfentra), Yuflyma, the anticancer drug Vegzelma, and Steqeyma posted double-digit growth in the fourth quarter."

Sales • Ankylosing Spondylitis • Colorectal Cancer • Crohn's disease • Hidradenitis Suppurativa • Idiopathic Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis • Uveitis

…The most prescribed…therapy in Japan (Pulse by Maeil Business News Korea) - "In autoimmune disease treatments, Remsima (infliximab) holds 43 percent, and Yuflyma (adalimumab) commands 14 percent, ranking first among biosimilars in their respective categories."

Commercial • Ankylosing Spondylitis • Crohn's disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis • Uveitis

Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved expanded indications for YUFLYMA (adalimumab-aaty) and its unbranded version, to include the treatment of hidradenitis suppurativa (HS) in adolescent patients aged 12 years and older, and uveitis (UV) in pediatric patients aged 2 years and older. (PRNewswire)

FDA approval • Hidradenitis Suppurativa • Uveitis

…Celltrion plans to establish a dedicated promotional booth at the congress to showcase its dermatology portfolio to attending medical professionals. [Google translation] (BioNews) - "This will include OMLYCLO, which is slated for launch in Europe later this year, along with Remsima SC, Yuflyma, and Steqeyma."

Biosimilar launch • Clinical • Ankylosing Spondylitis • Chronic Spontaneous Urticaria • Crohn's disease • Immunology • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Celltrion expands footprint in Italy with continued wins for autoimmune…drugs (Korea Biomedical Review) - "Celltrion’s Italian subsidiary recently won additional tenders for its ustekinumab biosimilar, Steqeyma, in the Veneto, Trentino-Alto Adige, and Sardinia regions, following earlier contracts in four regions this year...The company will supply the drug to seven regions in total through May 2026...Remsima IV won a recent tender in Umbria, while Remsima SC renewed its contract in Puglia, extending supply through May 2027...Celltrion’s adalimumab biosimilar Yuflyma is also gaining traction, with sales underway in Lazio and Umbria under contracts that will run for the next two to three years."

Commercial • Ankylosing Spondylitis • Crohn's disease • Hidradenitis Suppurativa • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Self-Injection Satisfaction and Safety of CT-P17 (Yuflyma), a High-Concentration Adalimumab Biosimilar, in Patients With Crohn's Disease: A Cross-Sectional Study. (PubMed, JGH Open) - "Its ergonomic autoinjector design supports ease of use. While larger studies are needed, these findings support the broader adoption of adalimumab biosimilars to enhance patient autonomy and reduce healthcare costs."

Journal • Observational data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Pain

Celltrion's operating profit hits record high in Q2 on strong sales of new high-margin drugs (Korea Biomedical Review) - "The company said its second quarter revenue reached 961.5 billion won ($690.5 million), up 9.9 percent year-on-year, while operating profit jumped 234.5 percent to 242.5 billion won -- both all-time highs for the second quarter...The strong performance was driven by robust demand for Remsima SC (marketed as Zymfentra in the U.S.), a subcutaneous infliximab biosimilar for autoimmune diseases, Yuflyma, an adalimumab biosimilar for rheumatoid arthritis and inflammatory conditions, Vegzelma, a bevacizumab biosimilar used in cancer treatment, and Steqeyma, a ustekinumab biosimilar targeting psoriasis and Crohn’s disease."

Commercial • Breast Cancer • Crohn's disease • Glioblastoma • Immunology • Inflammatory Bowel Disease • Non Small Cell Lung Cancer • Ovarian Cancer • Psoriasis • Rheumatoid Arthritis

Correction to: Repeated Switching Between CT-P17 and EU Reference Adalimumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: A Randomized, Double-Blind, Active-Controlled, Phase 3, Interchangeability Study. (PubMed, Adv Ther) - No abstract available

Clinical • P3 data • Dermatology • Immunology • Psoriasis

Bringing IBD treatment options to the table. The latest developments in the Celltrion Healthcare IBD portfolio. (BSG 2025) - "Adverse events should also be reported to Celltrion Healthcare by emailing [email protected] or calling +44 (0) 1753 983 500 For full indications, contraindications and information on special warnings, precautions and adverse events, please refer to the Summary of Product Characteristics. Please click here to view the Remsima® (infliximab) IV prescribing information: Please click here to view the Remsima® (infliximab) SC prescribing information: Please click here to view the Yuflyma®▼(adalimumab) prescribing information: Please click here to view the SteQeyma® (ustekinumab) prescribing information: UK--25-00086 May 2025"

Gastroenterology • Inflammatory Bowel Disease

SEX DIFFERENCES ASSOCIATED WITH OVERALL TOLERANCE AFTER A SWITCH TO AN ADALIMUMAB BIOSIMILAR, A POST-HOC ANALYSIS FROM THE YU-MATTER STUDY (EULAR 2025) - P | "Background: Guidelines for chronic inflammatory diseases or pain management do not include gender differences, even though differences exist between males and females regarding pain and treatment effect perceptions. This post-hoc analysis showed that women switching to CT-P17 were globally satisfied; however, women experienced higher pain and lower overall tolerance. This difference should be considered in day-to-day management to help the physician to prevent the nocebo effect in women, and specific studies should focus on this point."

Retrospective data • Ankylosing Spondylitis • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Pain • Pruritus • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Celltrion's YUFLYMA (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths (PRNewswire) - "Celltrion...announced that the U.S. Food and Drug Administration (FDA) has granted an expanded interchangeable designation for YUFLYMA (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations....YUFLYMA is approved for multiple inflammatory indications including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), ulcerative colitis (UC), plaque psoriasis (Ps), hidradenitis suppurativa (HS), and uveitis (UV) in adult patients; Crohn's disease (CD) in adults and pediatric patients 6 years of age and older; and juvenile idiopathic arthritis (JIA) in patients 2 years of age and older....The interchangeable designation builds on the Phase III interchangeability study....The expanded interchangeability designation for YUFLYMA is complemented by a strategic price reduction....The wholesale acquisition cost (WAC) list price of YUFLYMA has been reduced to $948 per syringe."

Commercial • FDA approval • Ankylosing Spondylitis • Crohn's disease • Hidradenitis Suppurativa • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis • Uveitis

Proactive Drug Monitoring versus Clinically-based Dosing for Endoscopic Healing in Pediatric Crohn's Disease Receiving Infliximab. (PubMed, Clin Gastroenterol Hepatol) - "Dosing based on proactive TDM was superior to clinically-based dosing in terms of EH in a randomized controlled trial of pediatric CD."

Journal • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • Pediatrics

Celltrion’s Yuflyma secures FDA interchangeability designation with Humira in US (Korea Biomedical Review) - "Celltrion said it has received U.S. FDA approval for an interchangeability designation between Yuflyma (ingredient: adalimumab), its biosimilar for autoimmune diseases, and the reference product Humira....Celltrion based its application on data from a global clinical trial involving 367 patients with moderate-to-severe plaque psoriasis....Humira generated approximately $8.99 billion in global sales in 2024, with more than 79 percent—$7.14 billion—coming from the U.S. market alone."

FDA approval • Sales • Immunology • Psoriasis