Idacio (adalimumab-aacf) / Fresenius Kabi - LARVOL DELTA

USE OF FK-ADA BIOSIMILAR (MSB 11022) IN CONTEXT OF BIOLOGIC SWITCH IN INFLAMMATORY BOWEL DISEASES: BASELINE DATA OF THE REAL WORLD IDEA STUDY (UEGW 2024) - "FK-ada is an adalimumab biosimilar approved for the treatment of inflammatory bowel diseases (IBD), Crohn’s disease (CD) and ulcerative colitis (UC). FK-ada is a well-known valuable therapeutic option in the treatment of IBD. 52-week IDEA data will support identification of predictive factors of FK-ada treatment persistence after switch."

Clinical • Real-world • Real-world evidence • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Rheumatology • Ulcerative Colitis

Evio Announces Groundbreaking Direct Purchase Agreement for Adalimumab Biosimilar (PRNewswire) - "Evio Pharmacy Solutions...announced the successful negotiation and implementation of an innovative direct purchase agreement with Fresenius Kabi, an operating company of Fresenius, for Adalimumab-aacf — a lower priced biosimilar version of Humira. Humira is one of the most widely prescribed and, at more than $12 billion annually, the highest revenue producing medication in the United States. This landmark direct purchase agreement creates a transparent, alternative business model that makes a highly effective treatment accessible to Evio owner health plans and their members at a lower cost."

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

FK-adalimumab MSB11022 showed similar efficacy on joints when compared to the adalimumab originator in the subgroup of chronic plaque psoriasis subjects suffering from concomitant PSA (results from the AURIEL-Pso study) (EADV 2024) - "Effect on joint measure with HAQ and PJA-VAS was similar in patients treated with FK-ada and originator at Week 16. Effects on patient ’ s quality of life support confidence in the use of FK-ada."

Clinical • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

FK-adalimumab MSB11022 showed similar efficacy on PASI 90 and PASI 100 when compared to the adalimumab originator in different subgroups of subjects suffering from moderate to severe chronic plaque psoriasis (results from the AURIEL-Pso study) (EADV 2024) - "Response rates were similar for PASI 90 and PASI 100 in different subgroups of subjects treated with FK-ada or the originator."

Clinical • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Psoriasis

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

Clinical outcomes of switching to adalimumab biosimilar (MSB11022) in patients with rheumatoid arthritis: RESTART Spanish Registry. (PubMed, Curr Med Res Opin) - "After a median follow-up of 8 months, median DAS28-CRP was 1.87 (86.0% in remission and 94.2% with low disease activity) and median CDAI was 4.00 (38.5% in remission and 95.3% with low disease activity). Only three patients experienced pain, swelling, and stinging at the injection site or a locally extensive hematoma in the area of administration. Adalimumab biosimilar MSB11022 maintained the efficacy benefits provided by previous adalimumab treatments with a safety profile in line with that already described for other biosimilars."

Clinical • Clinical data • Journal • Dermatology • Immunology • Inflammatory Arthritis • Pain • Psoriasis • Rheumatoid Arthritis • Rheumatology

DRUG PERSISTENCE WITH THERAPY OF ADALIMUMAB BIOSIMILAR, MSB11022, IN RHEUMATOLOGIC DISEASES (EULAR 2024) - "The evidence suggests that drug persistence of adalimumab biosimilar, MSB11022, was high in both treatment-naïve to biologics, or switched from other biologics groups at 27 months."

Ankylosing Spondylitis • Hematological Disorders • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

CLINICAL OUTCOMES OF SWITCHING TO ADALIMUMAB BIOSIMILAR (MSB11022) IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESTART SPANISH REGISTRY (EULAR 2024) - "Only 3.5% of the patients received biologic therapy prior to adalimumab; among them, the pre-adalimumab biologic treatments prescribed were certolizumab-pegol (66.7%) and tocilizumab (33.3%). The adalimumab biosimilar MSB11022 not only maintained the benefits provided by previous adalimumab treatments, but in some cases led to an improvement of these benefits, maintaining a safety profile in line with that already described for other biosimilars. Table 1. Clinical outcomes after switching from original or other biosimilars to MSB11022 CCP: cyclic citrullinated peptides; CDAI: Clinical Disease Activity Index; DAS28-PCR: Disease Activity Score 28 for rheumatoid arthritis with C-reactive protein."

Clinical • Clinical data • Cardiovascular • Dermatology • Diabetes • Gastroenterology • Gastrointestinal Disorder • Hypertension • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Metabolic Disorders • Pain • Psoriasis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • CRP

SAPHIR : Assessment of Predictive Factors for Persistence of Treatment After Initiation of Adalimumab With a Biosimilar (Adalimumab Fresenius KaBI or Substitution of Reference Adalimumab With the Fresenius Kabi Adalimumab Biosimilar in Patients With Chronic Inflammatory Diseases (clinicaltrials.gov) - P=N/A | N=600 | Recruiting | Sponsor: Fresenius Kabi, France | Trial completion date: Sep 2025 ➔ Dec 2025

Biomarker • Trial completion date • Ankylosing Spondylitis • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis

SAPHIR: Assessment of Predictive Factors for Persistence of Treatment After Substitution of Reference Adalimumab With the Fresenius Kabi Adalimumab Biosimilar in Patients With Chronic Inflammatory Diseases (clinicaltrials.gov) - P=N/A | N=600 | Recruiting | Sponsor: Fresenius Kabi, France | Trial completion date: Nov 2024 ➔ Sep 2025 | Trial primary completion date: Nov 2023 ➔ Sep 2025

Biomarker • Trial completion date • Trial primary completion date • Ankylosing Spondylitis • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis

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

Effectiveness and safety of adalimumab biosimilar in patients with inflammatory bowel disease. (PubMed, Farm Hosp) - "Between originator adalimumab and biosimilar-start cohorts, no differences were observed, between originator adalimumab and switch cohorts, no significant differences were found either, and with the pre- and post-switch to biosimilar comparison, 2 of the 9 patients experienced AEs after the switch. The biosimilar showed a favorable safety profile (one patient with a serious adverse effect (rash) with biosimilar discontinued treatment) and no significant changes to clinical or biochemical parameters were observed after the switch."

Journal • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis • CRP

Prospective evaluation of the switch from adalimumab originator to different biosimilars in IBD patients : acceptability and persistance at 1 year. (ECCO-IBD 2024) - "Methods From July 2020 to September 2021, we proposed for consecutive and ambulatory IBD patients on maintenance Humira® to switch to one of the five ADA biosimilars available at the time of the study (Amgevita®, Idacio®, Imraldi®, Hulio®, Hyrimoz®) at Lille University Hospital (France). Conclusion A large proportion of IBD patients (91.8%) accepted the switch from ADA originator to a biosimilar and 60% continued ADA biosimilar at 1 year. The high acceptability of the switch encourages the use of ADA biosimilars in clinical practice."

Clinical • Crohn's disease • Inflammatory Bowel Disease • Ulcerative Colitis

Effect of treatment with original or biosimilar adalimumab on SARS-CoV2 vaccination antibody titers. (PubMed, Int J Pharm X) - "The primary endpoint of our retrospective study was to find the differences in SARS-CoV-2 antibody amount between patients treated with original adalimumab and biosimilar adalimumab MSB11022 (Idacio) and the differences in the SARS-CoV-2 antibody amount between patients treated with and without biological treatment...All patients received the mRNA vaccine (Pfizer/BioNTech - BNT162b2), with a 21-day (interquartile range, 21-24) gap between the two vaccinations...A statistically significant difference in the SARS-CoV-2 antibody amount between the patients without biological treatment (median: 504.3 U/mL) and with biological treatment (Original and Biosimilar - median: 47.2 and 28.2 U/mL, respectively) was confirmed on day 182. According to our observation, the effect of the treatment type on the increase/decrease of antibodies over time is dominant, while the impact of other variables (gender, methotrexate treatment, autoimmune disease type, and age) was..."

Journal • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Rheumatology

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

Senderra Specialty Pharmacy announces that HUMIRA biosimilar products are now available to patients nationwide (PRNewswire) - "Senderra Specialty Pharmacy announced today that patients can access several HUMIRA biosimilar medications through Senderra's pharmaceutical manufacturing partnerships. This development allows patients to access biosimilars nationwide through Senderra Specialty Pharmacy conveniently. The HUMIRA biosimilar products offered by the following pharmaceutical manufacturers are now accessible to our patients: Amgen is offering AMJEVITA, (adalimumab), a biosimilar of HUMIRA; Coherus is offering YUSIMRY (adalimumab), a biosimilar of HUMIRA; Fresenius Kabi is offering IDACIO, (adalimumab), a biosimilar of HUMIRA; Organon is offering HADLIMA, (adalimumab), a biosimilar of HUMIRA; Sandoz is offering HYRIMOZ, (adalimumab), a biosimilar of HUMIRA."

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

Prometheus Laboratories Announces Collaboration with Fresenius Kabi on Anser Testing (BioSpace) - "Prometheus Laboratories Inc...announced a collaboration with Fresenius Kabi to support the validation of and access to Anser® therapeutic drug monitoring (TDM) services for eligible patients receiving the Fresenius Kabi biosimilar, IDACIO® (adalimumab-aacf). Anser testing is utilized by clinicians treating immune-mediated diseases such as Inflammatory Bowel Disease (IBD) and Rheumatoid Arthritis (RA) to gain objective information that helps to inform therapeutic decisions. This collaboration will also encompass the Fresenius Kabi biosimilars for tocilizumab and ustekinumab upon market availability."

Licensing / partnership • Immunology • Inflammatory Bowel Disease • Rheumatoid Arthritis

OPALE: A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response (clinicaltrials.gov) - P=N/A | N=754 | Completed | Sponsor: Fresenius Kabi | Recruiting ➔ Completed | Trial completion date: Sep 2022 ➔ Jan 2023 | Trial primary completion date: Sep 2022 ➔ Jan 2023

Trial completion • Trial completion date • Trial primary completion date • Ankylosing Spondylitis • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis

SAPHIR: Assessment of Predictive Factors for Persistence of Treatment After Substitution of Reference Adalimumab With the Fresenius Kabi Adalimumab Biosimilar in Patients With Chronic Inflammatory Diseases (clinicaltrials.gov) - P=N/A | N=600 | Recruiting | Sponsor: Fresenius Kabi, France | Not yet recruiting ➔ Recruiting

Enrollment open • Ankylosing Spondylitis • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis

IDACIO (adalimumab-aacf) Now Available in the United States (Businesswire) - "Fresenius Kabi announced today the immediate availability in the U.S. of its citrate-free adalimumab biosimilar IDACIO® (adalimumab-aacf) for use in the treatment of chronic autoimmune diseases for all eligible indications of the reference product, Humira® (adalimumab). IDACIO® is available in a self-administered prefilled syringe and a self-administered pre-filled pen (autoinjector)."

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

Patient tolerability of adalimumab biosimilar therapy in dermatology and rheumatology: real-world experience from a large tertiary centre (BAD 2023) - "Our experience with previous biosimilar switches within rheumatology and dermatology (etanercept, rituximab and infliximab) has resulted in few patients requiring a switch back to the originator...The higher proportion of patients citing injection pain may relate to the citrate excipient content or larger injection volume of the biosimilar Idacio...Switching may alter a patient’s confidence in the drug, which is particularly important when it may be a first-line therapy or the only approved biologic for a condition. Data on switch-back rates for other adalimumab biosimilars is required to understand how generalizable our findings are and the potential economic implications."

Clinical • Real-world • Real-world evidence • Ankylosing Spondylitis • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Inflammatory Arthritis • Pain • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Cost per responder of adalimumab biosimilars versus methotrexate in patients with psoriasis: a real-life experience. (PubMed, J Dermatolog Treat) - "A cost-per responder analysis comparing adalimumab biosimilars MSB11022 (Idacio®) and ABP 501 (Amgevita) versus subcutaneous methotrexate was performed. The week 52 cost-effectiveness of Idacio is comparable to subcutaneous methotrexate. The lowering of the cost of biosimilar drugs makes them a more accessible therapeutic option and they also can be introduced earlier in the treatment of moderate-to-severe psoriasis."

Journal • Dermatology • Immunology • Psoriasis

ADHERENCE ANALYSIS OF REAL-WORLD EVIDENCE FOR ADALIMUMAB BIOSIMILAR MSB11022 THERAPY IN RHEUMATOLOGIC DISEASES (EULAR 2023) - "This real-world evidence analysis suggests that patients switching to MSB11022, adalimumab biosimilar, will more likely maintain on therapy when compared to patients initiating MSB11022 therapy. In both cases, inflammatory arthritis patients had high adherence to MSB11022 therapy."

Adherence • Clinical • HEOR • Real-world • Real-world evidence • Ankylosing Spondylitis • Hematological Disorders • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

PHARMACOKINETIC EVALUATION OF A PROPOSED ADALIMUMAB BIOSIMILAR MSB11022 VERSUS THE US-LICENSED REFERENCE PRODUCT: RESULTS OF A RANDOMIZED, DOUBLE-BLIND, 3-ARM PARALLEL-GROUP, SINGLE-DOSE TRIAL IN HEALTHY SUBJECTS (DDW 2023) - "PK equivalence of MSB11022-acetate and US-RP was demonstrated with comparable immunogenicity, safety, and tolerability profiles. This study adds to the totality of evidence in support of MSB11022-acetate as a proposed adalimumab biosimilar."

Clinical • PK/PD data • Immunology • Oncology • TNFA

Adalimumab originator versus adalimumab biosimilars in inflammatory bowel disease in Australia. (PubMed, Expert Opin Biol Ther) - "The originator adalimumab Humira [by AbbVie, USA] and 4 adalimumab biosimilars (Amgevita [by Amgen, USA], Hadlima [by Organon, USA], Hyrimoz [by Sandoz, Switzerland] and Idacio [by Fresenius Kabi, Germany]) are included in this review. Adalimumab biosimilars are different from each other with unique advantages and disadvantages likely to influence prescriber and patients. Therefore, the choice of agent should be individualized to the needs of the patient and the healthcare service."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Pain • Rheumatoid Arthritis • Rheumatology