Exemptia (adalimumab biosimilar) / Zydus Lifesci, Ligand - LARVOL DELTA

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

Evaluation of Adalimumab Biosimilar (Exemptia: ZRC 3197) in the treatment of moderate to severe chronic plaque psoriasis with concomitant Psoriatic Arthritis (PsA) - An open labelled prospective pilot study. (EADV-Sp 2023) - "Sixteen patients were enrolled, one was withdrawn as he developed pulmonary tuberculosis, and four were lost to follow up. At week 12, PASI50 and DAPSA20 was achieved by 13 of 14 (93%) patients. DAPSA, PGA, and IGA scores also improved significantly."

Clinical • Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Pulmonary Disease • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • Tuberculosis • IFNG • IL17A • IL4 • TGFB1

The Long-Term Effects of Short-Period Adalimumab Biosimilar Usage in Ankylosing Spondylitis. (PubMed, Cureus) - "This unconventional method proved to be economically appealing. It merits further confirmation and acceptance, especially in resource-constrained contexts."

Journal • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Oncology • Pain • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A • IL6

[PREPRINT] Sustained effects of Short-term Adalimumab biosimilar (ZRC-3197) therapy on outcome measures in Ankylosing Spondylitis (medRxiv) - P=N/A | N=N/A | “Patients showed early and substantial significant improvement in pain, NSAID requirement, function, and in several indices (ASAS 20 & 40, ASAS partial remission, BASDAI, BASFI, ASDAS) which persisted after stopping injections. 84% and 52 % of patients respectively showed ASAS 20 improvement at weeks 12 and 48: corresponding to ASAS partial remission at 34% and 24%. Over 50% of patients maintained prolonged improvement and provided proof of concept (defined apriori). Serum Interleukin-6 assay showed a sharp reduction at 24 weeks. None developed TB or serious drug toxicity. 11 patients withdrew (mostly inadequate response). The absence of control was a limitation.”

Clinical data • Preprint • Ankylosing Spondylitis • Immunology • Inflammation

Current Knowledge of Biologics in Treatment of Noninfectious Uveitis. (PubMed, J Ocul Pharmacol Ther) - "Other drugs include anti-CD20 inhibitors (rituximab), interleukin-6R-inhibitor (tocilizumab), Interleukin-1R-inhibitor (anakinra), Iinterleukin-2-inhibitor (daclizumab), and the list is further increasing. New advances in biologics are the biosimilar molecules, which are biological products that are highly similar to the reference product, and they include Infimab (biosimilar of infliximab), Exemptia or Adfrar (biosimilar of adalimumab), and Intacept or Etacept (biosimilar of etanercept)...Thus, biologics are the future of uveitis treatment with promising results. This article aims to summarize the current knowledge on biologics and their clinical utility in the management of NIU."

Journal • Ankylosing Spondylitis • Immunology • Inflammation • Inflammatory Arthritis • Ocular Inflammation • Oncology • Ophthalmology • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Uveitis • IL1R1 • IL2 • IL6R

Comparative efficacy and safety of infliximab and its biosimilars in patients with rheumatoid arthritis presenting an insufficient response to methotrexate : A network meta-analysis. (PubMed, Z Rheumatol) - "No significant difference in ACR20 response rates and SAEs were detected between infliximab biosimilars and the originator in the investigated study populations."

Journal • Retrospective data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Comparative efficacy and safety of adalimumab biosimilars and adalimumab in patients with rheumatoid arthritis presenting an insufficient response to methotrexate: a network meta-analysis. (PubMed, Z Rheumatol) - "No significant difference was detected between adalimumab biosimilars and the originator in terms of ACR20 response rates and SAEs in the studied patients."

Journal • Retrospective data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

"Cadila Launches Cadalimab (biosimilar, adalimumab) in India @Cadila_Pharma https://t.co/bGst0nEaoI" (@Pharmashot)

Biosimilar launch

[VIRTUAL] MANAGING ANKYLOSING SPONDYLITIS (AS) WITH SHORT TERM BIOSIMILAR ADALIMUMAB REGIMEN IN A RESOURCE STRAPPED SETTING: A PROTOCOL DRIVEN COMMUNITY CLINIC ORIENTED STUDY (EULAR 2020) - "During the first year, patients were begun with 40 mg Bs Adalimumab (Bs-ADL) (Exemptia™), injected fortnight, for 12-16 weeks...None received steroids and 5 patients were begun on Sulfasalazine in the second year and monitored... This real life documented experience unravelled impressive long term benefits following a kick start short term induction regimen of Biosimilar Adalimumab in AS. Though contrary to standard practice, this seemed a practical solution in our setting. We speculate a psychological and motivational boost rather than a prolonged real time biological effect (Bs-ADL) for this phenomenon."

Clinical • Ankylosing Spondylitis • Complement-mediated Rare Disorders • Immunology • Ocular Inflammation • Ophthalmology • Rheumatology • Spondylarthritis • Uveitis • IL17A • IL6

Characterization of changes in lymphocyte subsets in baricitinib-treated patients with rheumatoid arthritis in a phase 3 study (RA-BEAM) (EULAR 2016) - P3, N=1,301; NCT01710358; Sponsor: Eli Lilly; "Changes in ALC and subpopulations with bari in RA-BEAM were largely within normal ranges...Sustained increases in ALC/T cells were only seen in ADA. A modest reduction in NK cells at wks 12 and 24 with bari was not associated with serious infection or HZ."

P3 data • Immunology • Rheumatoid Arthritis

Real-life Efficacy and Safety of Biosimilar Adalimumab (ZRC-3197) in Patients with Plaque Psoriasis: A Tertiary Care Center Experience. (PubMed, Indian Dermatol Online J) - "Treatment was well tolerated with no severe or serious adverse reactions requiring therapy discontinuation. This report serves as a real-life evidence for the efficacy and tolerability of biosimilar adalimumab administered for 16 weeks in patients with plaque psoriasis."

Clinical • Journal • Dermatology • Dermatopathology • Immunology • Psoriasis

The infectious profiles of biotherapeutic agents in an Algerian population (WCO-IOF-ESCEO 2016) - P=NA, N=107; “The products used were adalimumab (33.6 %) etanercept (29 %) rituximab (13 %) tocilizumab (13 %) and infliximab (11.2 %)…Infections events are more common in anti-TNFα treated patients than those on rituximab or tocilizumab.”

Clinical data • Biosimilar • Immunology

Pain Perception and Safety of Biosimilar Adalimumab (Exemptia™) in Patients with Axial Spondyloarthritis in Out-patient Department. (PubMed, J Assoc Physicians India) - No abstract available.

Clinical • Journal

Efficacy And Safety Of Adalimumab Biosimilar (Exemptia) In Moderate-To-Severe Steroid-Refractory Ulcerative Colitis Patients: Real-Life Outcomes In Resource-Constrained Setting At 24-Weeks Follow-Up. (PubMed, Biologics) - "ADA biosimilar (Exemptia) therapy is a safe and cost-effective alternative to original biologics in difficult-to-treat UC patients in resource-constrained Indian setting with comparable efficacy. Maintenance therapy at four weekly intervals can be considered in those patients who have shown an early clinical response at 12 weeks to minimize costs, but more studies are needed to confirm the same."

Clinical • Journal

Efficacy and safety of adalimumab biosimilar (Exemptia) in moderate-to-severe steroid-refractory ulcerative colitis patients: Real-life outcomes in resource-constrained setting at 24-weeks follow-up (Dovepress) - P=NA, N=25; "ADA biosimilar (Exemptia) therapy is a safe and cost-effective alternative to original biologics in difficult-to-treat UC patients in resource-constrained Indian setting with comparable efficacy."

Retrospective data

Real-life Tolerability and Effectiveness of Adalimumab Biosimilar in Ankylosing Spondylitis: the Adalimumab Biosimilar Patient Registry Data. (PubMed, ACR Open Rheumatol) - "The therapy was tolerated well, and there were no new unexpected adverse reactions with the biosimilar's use during this study. This report demonstrates the tolerability and effectiveness of bADA (Exemptia) after its clinical use for 24 weeks in real-world patients with AS from Indian clinical practice."

Clinical • Journal

Use of Adalimumab Biosimilar (exemptia) In Complicated IBD Patients, Single Centre Experience (APDW 2019) - "Adalimumab biosimilar can be considered as good alternative for the original drug and is showing good clinical response in complicated IBD patients"

Clinical

Real-Life Tolerability and Effectiveness of Adalimumab Biosimilar in Rheumatoid Arthritis: ASPIRE Registry Data. (PubMed, Rheumatol Ther) - "Real-life data from this post-marketing observational analysis demonstrate the clinical effectiveness and tolerability of 24 weeks of adalimumab biosimilar therapy in Indian patients with RA. This report also reflects upon the treatment strategies and prescription patterns for such therapies in Indian clinical practice."

Clinical • Journal