AcellBia (rituximab biosimilar) / Biocad, Kocak Farma - LARVOL DELTA

Outcomes of a 12-month course of early and late rituximab BCD020 biosimilar administration in juvenile systemic lupus erythematosus: A retrospective study. (PubMed, World J Nephrol) - "ERA demonstrated a better steroid-sparing effect and a possibility of earlier remission or low disease activity, except for lupus nephritis. Further investigations are required."

Journal • Retrospective data • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

The Use of "Acellbia"-A Biosimilar of Rituximab in Systemic Sclerosis. (PubMed, Dokl Biochem Biophys) - "The ''biosimilar'' versions of RTX might reduce the cost of therapy and increase patients accessibility to this treatment option. The RTX biosimilar Acellbia (ACB) has received approval in Russian Federation in 2014 for all indications held by reference RTX (including rheumatoid arthritis and ANCA-associated vasculitis)."

Journal • ANCA Vasculitis • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Sclerosis • Vasculitis

BCD020 rituximab bioanalog compared to standard treatment in juvenile systemic lupus erythematosus: The data of 12 months case-control study. (PubMed, World J Clin Pediatr) - "RTX can be considered as the option in the treatment of severe forms of SLE, due to its ability to arrest disease activity compared to SOCT."

Journal • Glomerulonephritis • Hematological Disorders • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Pediatrics • Renal Disease • Rheumatology • Systemic Lupus Erythematosus

Rituximab Biosimilar BCD020 Shows Superior Efficacy above Conventional Non-Biologics Treatment in Pediatric Lupus Nephritis: The Data of Retrospective Cohort Study. (PubMed, Biomedicines) - "Rituximab biosimilar BCD020 showed effectiveness in LN, whereas previous non-biologic treatment was insufficiently effective. Randomized controlled trials are required to evaluate the efficacy and safety of rituximab and evaluate the benefits when compared with conventional SLE treatment."

Journal • Retrospective data • Agranulocytosis • CNS Disorders • Glomerulonephritis • Granulocytopenia • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Pediatrics • Pneumonia • Pulmonary Disease • Renal Disease • Respiratory Diseases • Systemic Lupus Erythematosus

Comparative analysis of the results of treatment of a 12-month course of rituximab BCD020 biosimilar in systemic lupus erythematosus in children with early and late administration of the drug. (LUPUS-KCR 2023) - No abstract available

Clinical • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Drug Safety Differences with New Novel Therapies in RA (RheumNow) - "Safety outcomes for targeted synthetic or biological disease-modifying antirheumatic drugs (b/ts DMARDs) used to treat rheumatoid arthritis (RA) were studied using data from the Anti-Rheumatic Therapies in Sweden (ARTIS) registry...Significantly higher rates (vs etanercept) were observed on infliximab (18%), certolizumab pegol (15%) and rituximab (28%). The lowest rate was observed on tofacitinib (weighted HR=0.69 (0.49–0.96))."

Online posting

Improving treatment for hairy cell leukemia - "'A randomized trial comparing the current standard-of-care for untreated patients of Cladribine plus Rituximab versus Vemurafenib plus Rituximab would be a logical next step. A new standard of care may emerge,' Tallman said."

Media quote

Changes of lung function and skin fibrosis in patients with interstitial lung disease associated with systemic sclerosis on rituximab therapy - comparison of the efficacy of biosimilar Acellbia and Mabthera (EULAR 2022) - "Our prospective study showed the similar effectiveness of АСB in comparison with MBT in ILD-SSc. There was a significant improvement of lung function tests and decrease of skin fibrosis. RTX has been shown the positive effect even at low doses (less than 2 g)."

Clinical • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

Late-onset neutropenia after rituximab treatment in patients with ANCA-associated systemic vasculitis: a retrospective analysis of a register-based patient cohort (EULAR 2022) - "Three of the 5 death were noted in 2013-2014, which attributed to the use of cyclophosphamide >2 gm before RTX, as well as insufficient awareness of the risk of LON, which contributed to the delay in control of a full blood count, untimely diagnosis of LON and late treatment. At the beginning, the original drug Mabthera was used, while after 2014 biosimilar Acellbia was mainly used... LON after RTX therapy can develop in 11.4% of AAV pts, which exceeds the data for rheumatoid arthritis (1,3-3%) [1,2]. Our register data are lower than the rate of LON in AAV, presented by D. Tesfa et al. (23%) [1], which could be affected by the use of low-dose RTX for retreatment courses."

Retrospective data • Cardiovascular • Chronic Kidney Disease • Eosinophilic Granulomatosis With Polyangiitis • Hematological Disorders • Immunology • Infectious Disease • Inflammatory Arthritis • Langerhans Cell Histiocytosis • Myocardial Infarction • Neutropenia • Novel Coronavirus Disease • Pneumonia • Rare Diseases • Renal Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Septic Shock • Vasculitis

THE ROLE OF IL-6 IN PREDICTING INFLAMMATORY ACTIVITY BASED ON ULTRASONOGRAPHIC (US) EVIDENCE IN PATIENTS WITH RHEUMATOID ARTHRITIS DURING RITUXIMAB BIOSIMILAR (ACELLBIA «BIOCAD») THERAPY (EULAR 2022) - "IL-6 is the most promising marker for predicting persistent inflammatory activity according to PD in patients with RA on the RTX biosimilar therapy, other analyzed parameters have worse sensitivity and specificity."

Clinical • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CCL11 • CCL4 • FGF • IFNG • IL1B • IL2 • IL6 • TNFA

Hepatitis B Reactivation with Rituximab and Abatacept (RheumNow) - P=NA, N=1,937; "Hepatitis B reactivation is an uncommon complication of biologic therapy use....Being HBsAb positivity confers a lower risk of HBV reactivation; but if rituximab and abatacept use results in anti-HBs loss, then the risk of reactivation rises."

Clinical data

Safety and Efficacy of Intrathecal Rituximab in Patients With Multiple Sclerosis (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: St. Petersburg State Pavlov Medical University

Clinical • New P1 trial • CNS Disorders • Gene Therapies • Hematological Disorders • Immunology • Multiple Sclerosis • CD27 • CD5 • CD8 • MRI • PTPRC

[VIRTUAL] THE EFFECT OF RITUXIMAB BIOSIMILAR THERAPY ON THE EXPRESSION OF INTERFERON-STIMULATED GENES (“INTERFERON SIGNATURE”) IN PATIENTS WITH RHEUMATOID ARTHRITIS (EULAR 2021) - "Acellbia (BIOCAD) is the first Russian rituximab (RTX) biosimilar which was approved for medical use in rheumatoid arthritis (RA) patients in Russia and some CIS countries. Expression of IFN-stimulated genes was increased in RA patients compared to healthy donors. Increased RSAD2 and IFNGS expression was documented in patients with moderate effect of RTX therapy, therefore, these findings have important clinical relevance as predictors of RA clinical course which necessitates personified approach to treatment."

Clinical • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • IFIT1

[VIRTUAL] COMPARISON OF EFFICACY AND SAFETY OF BIOSIMILAR RITUXIMAB AND ORIGINATOR RITUXIMAB IN REAL CLINICAL PRACTICE (EULAR 2021) - "BS rituximab (RTX) Acellbia was developed by the Russian company “BIOCAD”. The results of the present study show that efficacy and safety of BSRTX and ORTX were comparable when they were used as the first biologics and when switching from ORTX to BSRTX. BSRTX can be used in routine clinical practice for the treatment of RA."

Clinical • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

[VIRTUAL] EFFICACY AND SAFETY OF TWO COURSES OF RITUXIMAB BIOSIMILAR ACELLBIA IN PATIENTS WITH INTERSTITIAL LUNG DISEASE ASSOCIATED WITH SYSTEMIC SCLEROSIS: A PROSPECTIVE OBSERVATIONAL STUDY (EULAR 2021) - "All pts were naive to ACB, received glucocorticoids in low doses, 10 (50%) pts were previously treated with immunosuppressants and 4(20%) of them continued to take mycophenolate mofetil as a concomitant therapy. The data from this prospective pilot study showed the effectiveness of the АСB in ILD-SSc. The clinical effect of АСB arises gradually and the baseline outcome measures reliably improve by the end of the first year. Our study have demonstrated a well-tolerated safety profile."

Clinical • Observational data • Cardiovascular • Fibrosis • Gastroenterology • Hematological Disorders • Hepatology • Immunology • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Oncology • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Scleroderma • Solid Tumor • Systemic Sclerosis • Thrombosis • Venous Thromboembolism

"#IBCD2020 @FAndreMD 'Journals have a strong responsibility, as they are the ones putting forward new topics....but who drives the scientific agenda?'" (@EORTC)

Multifaceted assessment of rituximab biosimilarity: The impact of glycan microheterogeneity on Fc function. (PubMed, Eur J Pharm Biopharm) - "Notably, we confirmed that the biosimilar had a higher level of afucosylated glycans, resulting in a stronger FcγIIIa binding affinity and increased ADCC activity. Taken together, our work provides a comprehensive comparison of Rituxan® and Acellbia®."

Journal

The role of laboratory biomarkers in monitoring of rituximab biosimilar therapy (Acellbia, "BIOCAD") in patients with rheumatoid arthritis (PubMed, Ter Arkh) - "Laboratory biomarkers were assessed at baseline and weeks 12 and 24 after the first infusion of RTX. RTM biosimilar induced decreases in DAS28, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) at week 12 and 24, p."

Biomarker • Clinical • Journal • Immunology • Rheumatoid Arthritis • Rheumatology

[VIRTUAL] EXPERIENCE WITH RITUXIMAB BIOSIMILAR BCD-020 IN PATIENTS WITH RHEUMATOID ARTHRITIS IN REAL-WORLD CLINICAL PRACTICE ACCORDING TO DATA FROM MOSCOW UNIFIED ARTHRITIS REGISTRY (MUAR) (EULAR 2020) - "The proportion of patients who received concomitant therapy with glucocorticoids or methotrexate (MTX) was 45.7% and 43.5%, respectively. Within the framework of routine clinical practice, switching from reference rituximab to BCD-020 biosimilar is not accompanied by a change in efficiency and safety profile of the therapy and does not pose a risk of discontinuation, which is coherent with the results of the registration clinical trial for BCD-020."

Clinical • Real-World Evidence • Immunology • Rheumatoid Arthritis • Rheumatology

"On #WorldBloodCancerDay, take a moment to review ✅"#𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭F𝐫𝐞𝐞R𝐞𝐦𝐢𝐬𝐬𝐢𝐨𝐧 𝐢𝐧 #𝐜𝐡𝐫𝐨𝐧𝐢𝐜𝐦𝐲𝐞𝐥𝐨𝐢𝐝𝐥&# (@cmlnet)

Hematological Malignancies

Study of safety and efficacy of BCD-020 comparing to Mabthera in patients with rheumatoid arthritis (BIORA) (clinicaltrials.gov) - P3, N=160 -> 308; Sponsor: Biocad; Recruiting.

Enrollment change • Biosimilar • Rheumatoid Arthritis

Biocad - World leader in biosimilar rituximab sales (PRNewswire) - “Biopharmaceutical company BIOCAD is now the world leader in sales of biosimilar rituximab. Company revenue from sales of Acellbia™, exceeded $155 million in 2014, representing more than 80% of global sales of non-originator rituximab biologicals...Most of BIOCAD's rituximab sales were in Russia, where the company won a series of federal government contracts..."

Sales • Biosimilar • Immunology • Rheumatoid Arthritis

Study of safety and efficacy of BCD-020 comparing to Mabthera in patients with rheumatoid arthritis (BIORA) (clinicaltrials.gov) - P3, N=160; Sponsor: Biocad; Recruiting; Primary completion date: Oct 2013 -> Jun 2015.

Trial primary completion date • Biosimilar • Immunology • Rheumatoid Arthritis

Comparison of efficacy and safety of rituximab biosimilar, BCD-020, and innovator rituximab in patients with active rheumatoid arthritis refractory to TNFA inhibitors (EULAR 2016) - P3, N=160; NCT02744196; Sponsor: Biocad; "ACR20 at Week 24 was reported in 84.14% patients in BCD-020 arm and 87.01% in reference arm. The 95% CI for the difference in proportion of ACR20 between groups was [-13.95; 8.74%], where the limits of 95% CI lie within the pre-specified equivalence margin."

P3 data • Biosimilar • Immunology • Rheumatoid Arthritis

Clinical comparability of BCD-020 to innovator rituximab in patients with indolent Non-Hodgkin’s lymphoma (EHA 2014) - Presentation time: Friday 13 June 2014, 17:45 - 19:00; Abstract #P448; P2/3, N=92; Sponsor: Biocad; NCT01701232; "BCD-020 is non-inferior to RTX in terms of efficacy on day 50±5, with equivalent PK and PD profile and immunogenicity. BCD-020 was well tolerated, with the safety profile comparable with RTX parameters."

P2/3 data • Biosimilar