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

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

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)...Methods 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...2 Barberio B et al . Gut 2023;72:264–74."

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

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."

Early Real-World Experience With Abrilada Within the Canadian Patient Population (ISPOR 2024) - "Results were compared to the reference adalimumab (D2E7, “ADL-Ref”) and other adalimumab biosimilars (ABP501, SB5, FKB327, GP2017, MSB11022, AVT02 and CT-P17) This retrospective cohort study utilized longitudinal claims data from IQVIA Canada’s Private Drug Plan and Ontario Drug Benefit databases... Our findings suggest high persistence and adherence rates for patients receiving adalimumab-afzb in a real-world setting. Further studies are needed to determine the persistence and adherence of adalimumab biosimilars over an extended duration."

Clinical • Real-world • Real-world evidence • Anesthesia • Hematological Disorders • Immunology • Pain

Celltrion secures major PBM contract for Yuflyma in the US (Korea Biomedical Review) - "Celltrion said Yuflyma (ingredient: adalimumab), a biosimilar referencing Humira, has been included in the formulary of one of the top three pharmacy benefit managers (PBMs) in the U.S. The three largest PBMs in the U.S., which include CVS Health, Express Scripts, and Optum, collectively manage about 80 percent of the market."

Reimbursement • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis

Clinical value of CT-P17 – From clinical trials to clinical practice (PANLAR 2024) - "Sponsored By CELLTRION"

Clinical

Celltrion launches Yuflyma 20mg for children with autoimmune diseases in US (Korea Biomedical Review) - "Celltrion...said it has launched a 20-mg dosage formulation of its biosimilar Yuflyma (adalimumab) to treat autoimmune diseases in pediatric patients in the U.S....It is available in a prefilled syringe (PFS), Celltrion said Thursday. The price of 20mg is the same as the previous dose formulation, considering Yuflyma's competitiveness and its needs in medical fields, the company said."

Launch US • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

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 (ECCO-IBD 2024) - "Background Subcutaneous (SC) CT-P13 provides patients and physicians with a new opportunity for maintenance treatment of Crohn’s disease (CD)...Methods 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...2 Barberio B et al . Gut 2023;72:264–74."

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

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 (ECCO-IBD 2024) - P | "Background Switching from a reference product (RP) to a biosimilar (BS) aims at generating cost savings. Conclusion 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 • Inflammatory Bowel Disease

Patient preferences for adalimumab in inflammatory bowel disease: a nationwide study from the GETAID (ECCO-IBD 2024) - "Results 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)...Two hundred twenty-three patients (23.7%) reported that they were previously treated with another adalimumab of which (32/223, 14.3%) discontinued treatment due to side effects. Conclusion In this real-world setting, patients with inflammatory bowel disease had a high level of satisfaction with adalimumab treatment, with some differences in terms of overall satisfaction and satisfaction with the injection device."

Clinical • Immunology • Inflammation • Inflammatory Bowel Disease

Celltrion’s 3 therapeutics win bidding orders in Peru (Korea Biomedical Review) - "Celltrion is expanding its market presence in Peru, a key Latin American market, with successful public tender wins....Successful bids continue to come not only in oncology but also in autoimmune diseases. Celltrion said Yuflyma (adalimumab) won the first tender for adalimumab in Peru, demonstrating the product's competitiveness. The tender was organized by the Workers' Insurance Service and is said to represent about 20 percent of the Peruvian adalimumab market."

Reimbursement • Crohn's disease • Immunology • Inflammatory Bowel Disease • Rheumatoid Arthritis • Ulcerative Colitis

Celltrion launches high-dose version of Yuflyma in US (Korea Biomedical Review) - "Celltrion said it launched the 80mg/0.8mL dosage form of Yuflyma, a biosimilar referencing Abbvie's Humira (ingredient: adalimumab), in the U.S....Yuflyma 80mg is a high-concentration formulation identical to the 40mg version that started selling last year....Yuflyma 80mg has also eliminated citrate, which can cause the patient pain, and substances that can trigger allergies, like the 40mg version. It maintains its safety at room temperature (25 Celcius) for up to 31 days, demonstrating Yuflyma's competitive product strength."

Biosimilar launch • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis • Ulcerative Colitis

Celltrion seeks US nod for interchangeability between Yuflyma and Humira (Korea Biomedical Review) - "Celltrion said Wednesday that it has applied to the U.S. Food and Drug Administration (FDA) for securing interchangeability between CT-P17 (adalimumab) and its original drug, AbbVie’s Humira, for treating autoimmune diseases. Celltrion's application for the interchangeability of CT-P17 (Yuflyma in brand name) and Humira is based on the results of a global phase 3 clinical trial."

sBLA • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriatic Arthritis • Ulcerative Colitis

Celltrion Announces Phase 3 Clinical Trial Results for CT-P17, Humira (Business Korea) - P3 | N=366 | NCT05495568 | Sponsor: Celltrion | "Celltrion revealed...that its biosimilar for autoimmune diseases, Yuflyma (CT-P17), has demonstrated equivalence and safety compared to the original drug, Humira....Celltrion reported that the global phase 3 clinical trials have proven the interchangeability between Yuflyma and Humira. The trials evaluated pharmacokinetics, efficacy, and safety, with similar results in secondary endpoints. Based on these clinical results, Celltrion plans to enter the process for obtaining interchangeability approval from the U.S. Food and Drug Administration (FDA)."

P3 data • PK/PD data • Immunology • Psoriasis • Psoriatic Arthritis

Yuflyma, A High Concentration and Citrate-free Adalimumab Biosimilar, Received FDA Approval for Treating Different Forms of Inflammatory Diseases. (PubMed, Antiinflamm Antiallergy Agents Med Chem) - No abstract available

FDA event • Journal • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Celltrion Healthcare showcases inflammatory bowel disease solutions (Nate) - "South Korean biopharmaceutical company Celltrion Healthcare Co. presented the Celltrion Group's inflammatory bowel disease (IBD) treatment to leading global healthcare professionals during its Global IBD Homecoming Day 2023...At a marketing session on the first day of the event, the company presented the features and real-world data of some of the company's latest developments, including Remsima SC, which has recently been approved in the United States (as Zymfentra), and Yuflyma (adalimumab). Participants noted the competitiveness of Remsima SC during the subsequent medical sessions, where discussions focused on the efficacy and safety data for both particularly increased and monotherapy doses, as confirmed in the global phase 3 post-analysis."

Real-world • Retrospective data • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Navigating adalimumab biosimilars: an expert opinion. (PubMed, J Comp Eff Res) - "The patent expiry of Humira in 2018 opened up the current European market to eight adalimumab biosimilars - (in alphabetical order) Amgevita, Amsparity, Hulio, Hukyndra, Hyrimoz, Idacio, Imraldi and Yuflyma - for the treatment of various immune and inflammatory conditions. This article explores the characteristics of various adalimumab biosimilars to help clinicians navigate the various options available across Europe and the USA. In addition to drug selection, effective patient-physician communication is needed to nurture realistic patient expectations and minimise potential nocebo effects when prescribing biosimilars."

Journal • Review

Celltrion USA announces distribution and incorporation of YUFLYMA (adalimumab-aaty), a Humira biosimilar, to CarePartners Specialty Pharmacy Cost Savings Programs (Businesswire) - "Celltrion USA, Inc...announced its FDA-approved biosimilar, YUFLYMA (adalimumab-aaty), has been added to CarePartners Specialty Pharmacy Cost Savings Programs. YUFLYMA is a high-concentration (100mg/mL) and citrate-free formulation of the Humira (adalimumab) biosimilar. CarePartners and its strategic partners will offer and distribute YUFLYMA as the lowest net cost high-concentration Humira (adalimumab) biosimilar to over 10 million plan members."

Reimbursement • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis • Ulcerative Colitis

Network Meta-Analysis to Evaluate the Comparative Efficacy of Biologics for Maintenance Treatment of Adult Patients With Crohn’s Disease (ACG 2023) - "CT-P13 subcutaneous (SC) provides patients with a new opportunity for maintenance treatment of their disease...Among 8 comparator arms, infliximab (IFX) SC 120 mg every 2 weeks (Q2W) showed the highest odds ratio (95% confidence interval [CI]) vs. PBO (3.52 [2.18–5.65]), followed by adalimumab (ADL) SC 40 mg Q2W (2.92 [1.90–4.47]), ustekinumab (UST) SC 90 mg every 8 weeks (Q8W) (2.79 [1.85–4.21]), IFX IV 5 mg/kg Q8W (2.55 [1.29–5.27]), vedolizumab (VDZ) IV 300 mg Q8W (2.33 [1.43–3.86]), risankizumab (RZB) SC 180 mg Q8W (1.80 [1.15–2.84]), VDZ SC 108 mg Q2W (1.76 [1.14–2.70]), and RZB SC 360 mg Q8W (1.60 [1.00–2.52])... Overall, 8 RCTs were included in the analysis (ACCENT I, LIBERTY-CD, CHARM, SEAVUE, GEMINI 2, VISIBLE 2, IM-UNITI, FORTIFY). Most studies enrolled both naïve and biologic- and/or Janus kinase inhibitor-exposed patients, apart from ACCENT-1 and SEAVUE which enrolled only anti-tumour necrosis factor- and biologic-naïve patients, respectively. The..."

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

Celltrion Healthcare to supply Yuflyma to US pharmacy chain (KED Global) - "South Korea's Celltrion Healthcare Co. has inked a deal with the US specialty pharmacy chain CarePartners Pharmacy to supply its autoimmune disease biosimilar Yuflyma (active ingredient: adalimumab). Set to be rolled out by month's end at CarePartners' outlets nationwide, the move potentially expands Yuflyma's reach to over 10 million patients. Yuflyma stands as a biosimilar counterpart to the widely-known autoimmune therapy, Humira, under Celltrion's portfolio....In a strategic move, CarePartners will sidestep the original Humira from its roster and refrain from enlisting other competing adalimumab biosimilars, effectively making Yuflyma the sole adalimumab product in its offerings."

Licensing / partnership • Crohn's disease • Hidradenitis Suppurativa • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Three biosimilars have now landed in our @SSMIBDCare New learning ✨ New experience ✨ Humira-adalimumab Amjevita- adalimumab-atto Cyltezo- adalimumab- adbm Yuflyma- adalimumab-aaty

Celltrion USA has signed a contract with Ventegra to add Yuflyma (adalimumab-aaty) as a preferred formulary product in both public and private insurance markets (Businesswire) - "Celltrion USA has signed a contract with Ventegra ®, a major U.S. Medical Benefits Manager (MBM) who administers pharmacy benefits through its Pharmacy Services Administration (PSA) model that has been effectively displacing traditional PBM’s. Ventegra will incorporate Yuflyma® (adalimumab-aaty) as a preferred drug in its formulary. As a result, Celltrion expands its performance in the U.S., the world's largest adalimumab market....By inclusion onto Ventegra’s formulary in both public and private insurance markets, Celltrion USA has secured access in the appropriate channel for approximately 3.6% of the entire U.S."

Licensing / partnership • US reimbursement • Ankylosing Spondylitis • Crohn's disease • Hidradenitis Suppurativa • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis • Uveitis

Celltrion gets sales approval for Yuflyma in Japan (KED Global) - "South Korea's biopharmaceutical company Celltrion Inc. announced...that it has secured approval from the Japanese Ministry of Health, Labour, and Welfare to market Yuflyma, a biosimilar of the acclaimed autoimmune disease drug, Humira. This approval enables Yuflyma to be used for the principal applications in Japan that Humira addresses, including rheumatoid arthritis, inflammatory bowel disease, and psoriasis."

Japanese regulatory • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis • Ulcerative Colitis