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

…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 UKadverseevents@celltrionhc.com 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

Celltrion secures bids for three autoimmune disease biosimilars in Italy [Google translation] (Chosun Biz) - "First, the Steqeyma biosimilar of Ustekinumab...has recently been awarded contracts in the Ustekinumab bids held by the governments of four regions in Italy, including Piedmont, Aosta Valley, Liguria, and Sardinia. Steqeyma is expected to be supplied to these areas until 2028...The YUFLYMA biosimilar of Adalimumab, for the treatment of rheumatoid arthritis and psoriasis from AbbVie, has also been successful in bidding. It was awarded in the Adalimumab bids held in regions including Lazio, Lombardy, and Umbria. Starting this month, YUFLYMA will be supplied to Lazio and Lombardy for the next three years and to Umbria for two years....The REMSIMA biosimilar of Infliximab from J&J has recently been awarded in the Umbria bids and is expected to be supplied for two years until 2027. The subcutaneous injection (SC) product of REMSIMA, REMSIMA SC, has also created a new market in the Sardinia state government, where there has been no bidding market for the Infliximab SC..."

Commercial • Ankylosing Spondylitis • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis • Ulcerative Colitis

Celltrion confirms Yuflyma's efficacy in interchangeability study published in journal (Chosun Biz) - P3 | N=367 | NCT05495568 | Sponsor: Celltrion | "Celltrion announced on the 4th that the results paper of the global clinical trial phase 3 on the interchangeability of the autoimmune disease treatment 'Yuflyma' (active ingredient adalimumab) and the original drug Humira has been published in the international journal 'Dermatology and Therapy'....This study is the result of the open-label extension study of Yuplyma alone, which was extended from the 27-week global clinical trial phase 3 conducted on Yeflyma and Humira to 52 weeks....As a result, the pharmacokinetic characteristics between the two groups were statistically equivalent, and similarities were observed in terms of efficacy and safety, the company explained....All results were consistently maintained throughout the open-label extension study period up to 52 weeks, regardless of previous dosing."

P3 data • Psoriasis

CT-P17 Adalimumab Biosimilar in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: An Open-Label Extension of a Phase 3 Interchangeability Study. (PubMed, Dermatol Ther (Heidelb)) - P3 | "PK, efficacy, safety, and immunogenicity findings remained consistent throughout the OLE, regardless of prior treatment, and were generally comparable across timepoints."

Clinical • Journal • P3 data • Dermatology • Immunology • Oncology • Psoriasis

Pharmacokinetics, Efficacy and Safety after Multiple Switches from Reference Adalimumab to Adalimumab Biosimilar (CT-P17) in comparison with the Maintenance Group (Reference Adalimumab) in Patients with Moderate-to-Severe Plaque Psoriasis: Week 52 Results from the Phase III Interchangeability Study (AAD 2025) - "No notable safety issue or increased in immunogenicity were observed following switching between ADA and CT-P17 up to Week 52. The similar pharmacokinetics, efficacy and safety profile support the interchangeability of CT-P17 and ADA."

Clinical • P3 data • PK/PD data • Dermatology • Immunology • Psoriasis

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) - P3 | "Week 27 primary PK results demonstrated bioequivalence, and the overall study results supported the interchangeability of CT-P17 and EU-adalimumab."

Clinical • Journal • P3 data • Dermatology • Immunology • Psoriasis

Network Meta-analysis to Evaluate the Comparative Efficacy of Advanced Therapies as First-Line Treatment for Maintenance Treatment of Adult Patients With Moderate to Severe Crohn's Disease (AIBD 2024) - "Background: Subcutaneous (SC) CT-P13 provides patients and physicians with a new opportunity for maintenance treatment of Crohn's disease (CD)... Eligible studies, identified by systematic literature review (PROSPERO no: CRD42023413752), evaluated the efficacy of maintenance therapy using intravenous (IV) or SC infliximab, SC adalimumab, IV or SC vedolizumab, SC ustekinumab, SC risankizumab or oral upadacitinib, in patients with moderate to severe CD who responded to induction therapy... In this updated NMA, SC infliximab 120 mg Q2W demonstrated a favorable profile in achieving clinical remission and endoscopic response when administered as a first-line advanced therapy for maintenance treatment of patients with moderate to severe CD."

Metastases • Retrospective data • Crohn's disease • Immunology • Inflammatory Bowel Disease

Advances in Adalimumab Biosimilar Usage in a Statewide Health System (AIBD 2024) - " A total of 22 IBD patients managed by a tertiary care center's specialty pharmacist were prescribed Adalimumab biosimilars, specifically Hadlima (ADA-BWWD), Amjevita (ADA-ATTO), Hyrimoz (ADA-ADAZ), and Yuflyma (ADA-AATY). Adalimumab biosimilars demonstrate comparable efficacy to the originator drug and are generally well-tolerated. The most common adverse effect is injection site reactions, potentially linked to the citrate-based formulation of the biosimilars. Laboratory values varied with disease severity and previous biologic failures."

Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • HLA-DQA1

Patient Satisfaction and Experience After a Switch to a Citrate-free High-concentration Adalimumab Biosimilar. Results from a Prospective Multicentric Real-world Study (ACR Convergence 2024) - P | "This real-world prospective study showed that the global experience of patients after the switch to CT-P17, a high concentration and citrate-free biosimilar of the reference adalimumab, was positive with no decrease in satisfaction with treatment, and a significant improvement in overall injection tolerance."

Clinical • Real-world • Real-world evidence • Ankylosing Spondylitis • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Pain • Pruritus • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Celltrion establishes subsidiary in Vietnam, targets approval for major products by year-end (Korea Biomedical Review) - "Celltrion said it officially established a local subsidiary in Vietnam, with plans to secure approval for the sale of its major products by the end of this year....Celltrion plans to start the marketing of four of its key products from next year. These include Remsima (infliximab), used to treat autoimmune diseases such as rheumatoid arthritis and Crohn’s disease; Remsima SC, a subcutaneous version of infliximab for the same conditions...By 2024, the company expects to receive approval for three more products -- Yuflyma (ingredient: adalimumab)...and Omaliclo (ingredient: omalizumab)."

Approval • Asthma • Crohn's disease • Immunology • Inflammatory Bowel Disease • Rheumatoid Arthritis

Pharmacokinetics, Efficacy and Safety after Multiple Switches from Reference Adalimumab to Adalimumab Biosimilar (CT-P17) in comparison with the Maintenance Group (Reference Adalimumab) in Patients with Moderate-to-Severe Plaque Psoriasis: Week 27 Results from the Phase III Interchangeability Study (EADV 2024) - "The equivalent PK and similar efficacy and safety profile support the interchangeability of CT-P17 and ADA."

Clinical • P3 data • PK/PD data • Dermatology • Immunology • Psoriasis

An acquired type of perforating dermatosis due to anti TNF alpha inhibitor in a psoriatic woman (EADV 2024) - "In September 2023 ongoing therapy with Adalimumab biosimilar GP2017 has been replaced with one other Adalimumab biosimilar CT-P17 because of drug availability issues...Rheumatologic consultation was performed therefore prednisone 25 mg daily orally and methotrexate 12,5 mg subcutaneous injections weekly were started... Perforating dermatoses are characterized by the elimination of dermal connective tissue through the epidermis. The etiopathogenesis is not completely understood. Underlying conditions as diabetes and chronic renal insufficiency are frequently associated."

Clinical • Chronic Kidney Disease • Dermatology • Diabetes • Immunology • Inflammatory Arthritis • Metabolic Disorders • Nephrology • Psoriasis • Psoriatic Arthritis • Renal Disease • Rheumatology • Seronegative Spondyloarthropathies

Patient Satisfaction and Experience with CT-P17 Following Transition from Reference Adalimumab or Another Adalimumab Biosimilar: Results from the Real-World YU-MATTER Study. (PubMed, BioDrugs) - P | "The majority of patients had stable or increased treatment satisfaction after switching from R-ADA or an ADA-BioS to CT-P17. In particular, switching to CT-P17 from a low-concentration ADA-BioS or an ADA-BioS containing citrate was associated with increased patient satisfaction. An improvement in overall tolerance with CT-P17 versus previous adalimumab treatment was also reported."

Journal • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Pain • Rheumatology

Adalimumab originator and biosimilars in global inflammatory bowel disease treatment (AGW-GESA 2024) - "Products marketed in Australia, namely Humira, Yuflyma, Idacio, Hyrimoz, Hadlima, Abrilada, and Amgevita, as well as Exemptia in India, provide the most extensive support. Adalimumab products exhibit variations in formulations and associated support programs across different countries. Among the four products offering high-concentration citrate-free formulations, Humira and Xelenka offer a wide range of dosages for different indications. Meanwhile, Xelenka, Yuflyma, and Ardalicip provide the longest room temperature shelf lives, which is favourable for travellers."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics