Hulio (adalimumab-fkjp) / Fujifilm Kyowa Kirin Biologics, Biocon - LARVOL DELTA

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

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

Performance evaluation of an adalimumab biosimilar autoinjector and its reference device: comparative use human factors study in patients with rheumatoid arthritis and juvenile idiopathic arthritis. (PubMed, Drug Deliv) - "A Comparative Use Human Factors study was conducted to assess whether the injection success rate (SR) with biosimilar adalimumab-fkjp (Bios-ADA) autoinjector (Hulio®) is comparable to reference adalimumab (Ref-ADA) autoinjector (Humira®), accounting for design differences, including the absence of an activation button, to evaluate usability in the target patient population...Bios-ADA autoinjector was non-inferior to Ref-ADA autoinjector, and design differences did not introduce clinically significant use-related risks. The Bios-ADA autoinjector can be used as a practical alternative to the Ref-ADA autoinjector from a usability perspective, with comparable overall performance during self-administration."

Clinical • Journal • Crohn's disease • Gastroenterology • Idiopathic Arthritis • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Pediatrics • Rheumatoid Arthritis • Rheumatology

Effectiveness and safety of adalimumab biosimilar in bio-naive patients with inflammatory bowel disease: a real-life multicenter observational study comparing ABP501, SB5, MSB11022, GP2017, and FKB327. (PubMed, Crohns Colitis 360) - "Furthermore, there is no significant difference between the 5-ADA biosimilars. Drug persistence was significantly higher in patients with CD treated with IMM and with post-induction ADA levels ≥7 μg/mL."

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

Biocon Biologics has obtained global manufacturing and commercial rights for Hulio, a biosimilar of Adalimumab, through an agreement with Fujifilm Kyowa Kirin Biologics. (GeneOnline) - "The agreement focuses on Hulio, which is a biosimilar version of Adalimumab, a medication commonly used to treat autoimmune diseases such as rheumatoid arthritis and Crohn’s disease. This development positions Biocon Biologics to manage both the production and distribution of Hulio across global markets."

Licensing / partnership • Crohn's disease • Rheumatoid Arthritis

Evaluation of Methods Employed in Establishing Preclinical Similarity of Adalimumab Biosimilars. (PubMed, Adv Pharmacol Pharm Sci) - "This review analyses published preclinical studies to assess the evaluation methods employed to establish biosimilarity between Humira and four key biosimilars: ABP501 (Amjevita), FKB327 (Hulio), MSB11022 (Idacio), and SB5 (Imraldi). Notably, while all four biosimilars demonstrated comparable functional properties to the reference product, variations in glycosylation patterns presented distinct regulatory challenges. This review is a valuable resource for biopharmaceutical scientists engaged in biosimilar development, ultimately supporting advancing more accessible and affordable treatment options while ensuring adherence to stringent efficacy, safety, and quality standards of adalimumab biosimilars."

Journal • Preclinical • Review • Immunology • Oncology • TNFA

Multiple Switches Between Adalimumab-fkjp and Reference Adalimumab in Moderate-to-Severe Chronic Plaque Psoriasis: A Multicenter, Double-Blind, Parallel Group, Randomized Clinical Trial for Interchangeability. (PubMed, Adv Ther) - P3 | "Patients receiving adalimumab-fkjp (low concentration) and reference adalimumab (high concentration) in alternate fashion had similar PK, efficacy, safety, and immunogenicity profile. Interchangeability status has been granted to adalimumab-fkjp."

Clinical • Journal • Dermatology • Immunology • Psoriasis

Experimental Medicine Studies of the Brain in Patients With Rheumatoid Arthritis REALISE (clinicaltrials.gov) - P=N/A | N=46 | Completed | Sponsor: NHS Greater Glasgow and Clyde | Active, not recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

FREE: De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease (clinicaltrials.gov) - P4 | N=148 | Enrolling by invitation | Sponsor: University Medical Center Groningen | Trial completion date: Mar 2025 ➔ Mar 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Experimental Medicine Studies of the Brain in Patients With Rheumatoid Arthritis REALISE (clinicaltrials.gov) - P=N/A | N=46 | Active, not recruiting | Sponsor: NHS Greater Glasgow and Clyde | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2024 ➔ Nov 2024 | Trial primary completion date: Jul 2024 ➔ Nov 2024

Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Multiple switching between the biosimilar adalimumab-fkjp low concentration and reference adalimumab high concentration in patients with chronic plaque psoriasis: a phase 3, double-blind, randomised, parallel-group study (EADV 2024) - "This study confirmed that the subjects receiving adalimumab-fkjp low concentration and adalimumab high concentration in alternate fashion had highly similar time concentration curves compared to continuous administration of adalimumab, and demonstrated PK equivalence between switching and non-switching arms. The efficacy, safety and immunogenicity profile was similar between the arms. The overall data supports interchangeability between adalimumab and adalimumab-fkjp."

Clinical • P3 data • Dermatology • Immunology • Psoriasis

Biocon Biologics Announces New Dermatology Data to Be Presented at EADV Congress 2024 (Canada Newswire) - P3 | N=386 | NCT05637515 | Sponsor: Biocon Biologics UK Ltd | "The overall number and proportion of patients with Psoriasis Area and Severity Index (PASI) responses and static Physicians Global Assessment (sPGA) success were highly similar between the two arms at week 28. Treatment-emergent Adverse Events were comparable between switching [54 subjects (29.8%)] and non-switching arms [66 subjects (34.2%)]. The overall number and proportion of patients with PASI responses and sPGA success were highly similar between the two arms at week 28. This study confirmed that the subjects receiving adalimumab-fkjp low concentration and adalimumab high concentration in alternate fashion had highly similar time concentration curves compared to continuous administration of high-concentration reference adalimumab, and demonstrated PK equivalence between switching and non-switching arms."

P3 data • Dermatology • Immunology • Psoriasis

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

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

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

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

CAMEO: Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease (clinicaltrials.gov) - P4 | N=900 | Recruiting | Sponsor: Connecticut Children's Medical Center | Phase classification: P ➔ P4

Phase classification • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Oncology

A Systematic Review Evaluating the Efficacy, Immunogenicity and Safety of the Biosimilar FKB327 in Treating Rheumatoid Arthritis. (PubMed, Mymensingh Med J) - "Safety was assessed through the development of complications after the administration of the drugs. The review concludes that there are similarities in efficacy, immunogenicity and safety between FKB327 but could not adequately prove the superiority of FKB327 over Adalimumab."

Journal • Review • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Biocon Biologics Concludes Integration of Acquired Biosimilars Business in ~120 countries (Biocon Press Release) - "Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd...announced the successful completion of the transition of the acquired biosimilars business in ~120 countries across Advanced and Emerging Markets, a year ahead of schedule....All Viatris’ biosimilar brands, including...Hulio® (bAdalimumab), Nepexto® (bEtanercept), Semglee® (bGlargine)...will now be marketed by Biocon Biologics teams, ensuring business continuity for patients, prescribers, partners, and healthcare systems."

M&A • Crohn's disease • Diabetes • Immunology • Inflammatory Bowel Disease • Metabolic Disorders • Psoriasis • Ulcerative Colitis

FREE: De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease (clinicaltrials.gov) - P4 | N=148 | Enrolling by invitation | Sponsor: University Medical Center Groningen | Recruiting ➔ Enrolling by invitation | Trial completion date: Jun 2023 ➔ Mar 2025

Enrollment status • Trial completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • 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

Experimental Medicine Studies of the Brain in Patients With Rheumatoid Arthritis REALISE (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: NHS Greater Glasgow and Clyde | Trial completion date: Dec 2025 ➔ Jul 2024 | Trial primary completion date: Dec 2025 ➔ Jul 2024

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • BRAF

Hulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and Immunogenicity (clinicaltrials.gov) - P3 | N=386 | Completed | Sponsor: Mylan Pharmaceuticals Inc | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Experimental Medicine Studies of the Brain in Patients With Rheumatoid Arthritis REALISE (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: NHS Greater Glasgow and Clyde | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • BRAF

CAMEO: Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease (clinicaltrials.gov) - P=N/A | N=900 | Recruiting | Sponsor: Connecticut Children's Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Oncology