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

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

Celltrion's autoimmune disease biosimilars achieve solid growth in Italy (Korea Biomedical Review) - "Celltrion said its autoimmune disease biosimilars are making significant strides in Italy, one of the five largest pharmaceutical markets in EU. The other four are Germany, Spain, the U.K., and France. Notably, the company's Italian subsidiary has successfully secured bids, particularly for Yuflyma (ingredient: adalimumab), a biosimilar referencing Humira to treat autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease, and psoriasis."

Commercial • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis

To Compare Pharmacokinetics, Efficacy, and Safety of CT-P17 With Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - P3 | N=367 | Completed | Sponsor: Celltrion | Recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis • Psoriatic Arthritis

Celltrion USA announces incorporation of adalimumab-aaty, a Humira biosimilar, to the Costco Member Prescription Program (PRNewswire) - "Celltrion USA...announced its FDA-approved biosimilar adalimumab-aaty, has been added to the Costco member prescription program. Adalimumab-aaty is a high-concentration (100mg/mL) and citrate-free biosimilar to Humira (adalimumab). Adalimumab-aaty is approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, and Hidradenitis Suppurativa.....The Costco Member Prescription Program is a prescription drug discount card program that provides eligible Costco members and their eligible dependents the ability to obtain lower prices on adalimumab-aaty and other participating drugs at participating pharmacies."

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

Patient preferences for adalimumab in inflammatory bowel disease: a nationwide study from the GETAID. (PubMed, Therap Adv Gastroenterol) - "The most commonly used drugs at inclusion were Humira® (436/941, 46.3%), Amgevita® (177/941, 18.8%) and Hulio® (105/941, 11.2%)...Satisfaction with the subcutaneous injection form was higher for patients treated with Yuflyma® (9.0 (1.4)), Humira (8.9 (1.3)) and Hulio (8.9 (1.7)) (p < 0.05)...In all, 223 patients (23.7%) reported being previously treated with another adalimumab of which (32/223, 14.3%) discontinued treatment due to side effects. In this real-world setting, patients with IBD had a high level of satisfaction with adalimumab treatment, with some differences in terms of overall satisfaction and satisfaction with the injection device."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

PERCEIVED NEED FOR TREATMENT IS ASSOCIATED WITH PATIENT SATISFACTION AFTER A SWITCH TO A BIOSIMILAR; HEALTH LITERACY IS OFTEN LIMITED: A PROSPECTIVE MULTICENTRE OBSERVATIONAL STUDY OF 232 PATIENTS (EULAR 2024) - P | "Objectives: To analyse patient beliefs about medicine and health knowledge that may impact patients' satisfaction after a switch to a BioS of adalimumab. This real-world study showed that patients switching to CT-P17 were generally convinced of the treatment necessity; the differential between necessity and concerns about the treatment was associated to a higher satisfaction with CT-P17. The level of health literacy was problematic or insufficient in around half of these patients with long-standing disease and long-standing biologic use. These results suggest that although satisfaction with switching was generally high, beliefs and concerns remain important and could lead to non-adherence."

Clinical • Observational data • Ankylosing Spondylitis • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Ulcerative Colitis

PATIENT SATISFACTION AND EXPERIENCE AFTER A SWITCH TO AN ADALIMUMAB BIOSIMILAR WITH HIGH CONCENTRATION AND CITRATE-FREE: RESULTS FROM A MULTICENTRIC PROSPECTIVE REAL-LIFE STUDY (EULAR 2024) - P | "Background: Switching from a reference product (RP) to a biosimilar (BS) aims to generate savings. The global experience of switching to CT-P17 was positive with an overall improvement in injection tolerance. Injection volume was an independent factor associated with a successful experience."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Pain • Pruritus • Rheumatology • Seronegative Spondyloarthropathies

NETWORK META-ANALYSIS TO EVALUATE THE COMPARATIVE EFFICACY OF ADVANCED THERAPIES AS FIRST LINE FOR MAINTENANCE TREATMENT OF ADULT PATIENTS WITH MODERATE-TO-SEVERE CROHN’S DISEASE (DDW 2024) - "Background Subcutaneous (SC) CT-P13 provides patients and physicians with a new opportunity for maintenance treatment of Crohn's disease (CD)...: CRD4 0 341375 ) 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...Barberio B et al . Gut 0 3;7 : 64-74."

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

Celltrion USA's adalimumab-aaty biosimilar to HUMIRA now available at low wholesale acquisition cost (PRNewswire) - "Celltrion USA announced today that adalimumab-aaty, the company's high-concentration (100 mg/mL) and citrate-free formulation biosimilar to HUMIRA (adalimumab), is now available at a low wholesale acquisition cost (WAC). Adalimumab-aaty will be priced as WAC list price at an 85% discount to the current WAC list price of HUMIRA. Adalimumab-aaty is also available from Celltrion USA under the brand name YUFLYMA, which launched in July 2023 and is available at a 5% discount to the current WAC list price of HUMIRA. Adalimumab-aaty is approved for the treatment of eight conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa."

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

Australia’s PBAC Recommends Three Biosimilars for Reimbursement (Pearce IP) - "Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes of the applications for reimbursement considered at its March 2024 meeting. The following biosimilars have been recommended for listing on the Pharmaceutical Benefits Scheme (PBS): Amgen’s Wezlana (ustekinumab); and Celltrion’s Yuflyma (adalimumab)...In addition, the following biopharmaceuticals have been recommended for first time listing on the PBS:...and Saphnelo (anifrolumab) for the treatment of patients with severe systemic lupus erythematosus with high disease activity despite standard of care; UCB’s Bimzelx (bimekizumab) for the treatment of severe psoriatic arthritis; new forms of Janssen-Cilag’s Stelara (ustekinumab), as 45 mg and 90 mg pre-filled syringe (PFS) and pre-filled pen (PFP)."

Reimbursement • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Systemic Lupus Erythematosus • Ulcerative Colitis

Mechanisms and management of loss of response to anti-TNF therapy for patients with Crohn's disease: 3-year data from the prospective, multicentre PANTS cohort study. (PubMed, Lancet Gastroenterol Hepatol) - P=N/A | "Only around a third of patients with active luminal Crohn's disease treated with an anti-TNF drug were in remission at the end of 3 years of treatment. Low drug concentrations at the end of the induction period predict loss of response by year 3 of treatment, suggesting higher drug concentrations during the first year of treatment, particularly during induction, might lead to better long-term outcomes. Anti-drug antibodies associated with undetectable drug concentrations of infliximab, but not adalimumab, can be predicted by carriage of HLA-DQA1*05 and mitigated by concomitant immunomodulator use for both drugs."

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Infectious Disease • Inflammatory Bowel Disease • Obesity • HLA-DQA1

An Analysis of Stakeholders’ Contribution to High-WAC and Low-WAC Adalimumab Products in 2025 Under the Inflation Reduction Act in the United States (ISPOR 2024) - "Comparing each stakeholder’s contribution in Medicare program in 2025, the financial burden for Medicare, commercial plans and manufacturers is significantly reduced in low-WAC products compared to that of high-WAC products."